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Clinical Trial Results:
A 52-Week, Open-Label, Single-Arm Study to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects with Parkinson's Disease

Summary
EudraCT number	2018-002144-85
Trial protocol	GB DK NL ES BE DE IT
Global end of trial date	17 Aug 2022

Results information
Results version number	v2(current)
This version publication date	10 Nov 2023
First version publication date	30 Aug 2023
Other versions	v1
Version creation reason	Correction of full data set Minor clarifying edits to related to units of measure and an endpoint title.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M15-741

ISRCTN number

US NCT number

NCT03781167

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB

Public contact

Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com

Scientific contact

Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

17 Aug 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Aug 2022

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Protection of trial subjects

Subject read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Apr 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 7

Country: Number of subjects enrolled

Canada: 9

Country: Number of subjects enrolled

Australia: 27

Country: Number of subjects enrolled

Denmark: 9

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

Japan: 27

Country: Number of subjects enrolled

Netherlands: 6

Country: Number of subjects enrolled

Russian Federation: 8

Country: Number of subjects enrolled

Spain: 28

Country: Number of subjects enrolled

Sweden: 8

Country: Number of subjects enrolled

United Kingdom: 13

Country: Number of subjects enrolled

United States: 81

Worldwide total number of subjects

244

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

119

From 65 to 84 years

124

85 years and over

Subject disposition

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Recruitment details

Screening details

This study had a 10 to 42-day Screening Period, during which a 6-day Monitoring Period was completed.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

ABBV-951 Low Dose Subgroup

Arm description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

Arm type

Experimental

Investigational medicinal product name

ABBV-951

Investigational medicinal product code

Other name

Foslevodopa/Foscarbidopa

Pharmaceutical forms

Solution for infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Solution for continuous subcutaneous infusion (CSCI)

ABBV-951 High Dose Subgroup

Arm description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Arm type

Experimental

Investigational medicinal product name

ABBV-951

Investigational medicinal product code

Other name

Foslevodopa/Foscarbidopa

Pharmaceutical forms

Solution for infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Solution for continuous subcutaneous infusion (CSCI)

Number of subjects in period 1	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup
Started	131	113
Completed	84	65
Not completed	47	48
Adverse event, non-fatal	23	25
Other, not specified	2	2
Withdrew consent	16	12
Lost to follow-up	-	1
Difficulty with drug delivery system	2	3
Lack of efficacy	4	5

Baseline characteristics

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Reporting group title

ABBV-951 Low Dose Subgroup

Reporting group description

Reporting group title

ABBV-951 High Dose Subgroup

Reporting group description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Reporting group values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	Total
Number of subjects	131	113	244
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	63.5 ( 8.87 )	64.4 ( 9.54 )	-
Gender categorical
Units: Subjects
Female	66	32	98
Male	65	81	146
Ethnicity
Units: Subjects
Hispanic or Latino	8	12	20
Not Hispanic or Latino	123	101	224
Unknown or Not Reported	0	0	0
Race
Units: Subjects
American Indian or Alaska Native	1	0	1
Asian	27	7	34
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	102	105	207
More than one race	1	0	1
Unknown or Not Reported	0	0	0

End points

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Reporting group title

ABBV-951 Low Dose Subgroup

Reporting group description

Reporting group title

ABBV-951 High Dose Subgroup

Reporting group description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Subject analysis set title

ABBV-951 Low Dose Subgroup

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

ABBV-951 High Dose Subgroup

Subject analysis set type

Per protocol

Subject analysis set description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Subject analysis set title

ABBV-951 All Participants

Subject analysis set type

Per protocol

Subject analysis set description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.

Primary: Number of Participants With Adverse Events

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End point title

Number of Participants With Adverse Events ^[1]

End point description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

End point type

Primary

End point timeframe

From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive data are summarized for this end point per protocol.

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[2]	113 ^[3]	244 ^[4]
Units: participants
Any TEAE	121	109	230
TESAE	32	31	63

Notes
[2] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[3] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[4] - Safety Analysis Set: all participants who received any ABBV-951 infusion

No statistical analyses for this end point

Primary: Number of Participants With Adverse Events of Special Interest

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End point title

Number of Participants With Adverse Events of Special Interest ^[5]

End point description

Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.

End point type

Primary

End point timeframe

From first dose of study drug until 30 days following last dose of study drug (up to 480 days)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive data are summarized for this end point per protocol.

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[6]	113 ^[7]	244 ^[8]
Units: participants
Infusion site infections	42	44	86
Infusion site reactions	103	97	200
Hallucinations/psychosis	32	29	61
Falls and associated injuries	37	37	74
Polyneuropathy (peripheral neuropathy)	14	13	27
Weight loss	12	15	27
Somnolence	9	3	12

Notes
[6] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[7] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[8] - Safety Analysis Set: all participants who received any ABBV-951 infusion

No statistical analyses for this end point

Primary: Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale

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End point title

Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale ^[9]

End point description

Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE).

End point type

Primary

End point timeframe

Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive data are summarized for this end point per protocol.

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[10]	113 ^[11]	244 ^[12]
Units: participants	10	15	25

Notes
[10] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[11] - Safety Analysis Set: all participants who received any ABBV-951 infusion
[12] - Safety Analysis Set: all participants who received any ABBV-951 infusion

No statistical analyses for this end point

Primary: Hematocrit (Hematology): Change From Baseline to End of Study

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End point title

Hematocrit (Hematology): Change From Baseline to End of Study ^[13]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol.

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	128 ^[14]	113 ^[15]	241 ^[16]
Units: proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 6 (n=94, 91, 185)	-0.02 ( 0.031 )	-0.02 ( 0.029 )	-0.02 ( 0.030 )
Week 26 (n=69, 61, 130)	-0.01 ( 0.030 )	-0.02 ( 0.026 )	-0.02 ( 0.028 )
Week 39 (n=61, 53, 114)	-0.02 ( 0.028 )	-0.02 ( 0.029 )	-0.02 ( 0.028 )
Week 52 (n=62, 56, 118)	-0.02 ( 0.029 )	-0.02 ( 0.028 )	-0.02 ( 0.029 )

Notes
[14] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[15] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[16] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Hemoglobin (Hematology): Change From Baseline to End of Study

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End point title

Hemoglobin (Hematology): Change From Baseline to End of Study ^[17]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[18]	113 ^[19]	243 ^[20]
Units: g/L
arithmetic mean (standard deviation)
Week 6 (n=98, 93, 191)	-5.00 ( 8.308 )	-6.82 ( 9.222 )	-5.89 ( 8.789 )
Week 26 (n=71, 63, 134)	-5.42 ( 9.296 )	-4.48 ( 7.502 )	-4.98 ( 8.482 )
Week 39 (n=68, 53, 121)	-5.74 ( 8.430 )	-6.58 ( 8.601 )	-6.11 ( 8.480 )
Week 52 (n=69, 56, 125)	-7.96 ( 8.862 )	-5.80 ( 9.308 )	-6.99 ( 9.091 )

Notes
[18] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[19] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[20] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study

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End point title

Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study ^[21]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[22]	113 ^[23]	243 ^[24]
Units: cells*10^12/L
arithmetic mean (standard deviation)
Week 6 (n=96, 93, 189)	-0.15 ( 0.261 )	-0.21 ( 0.296 )	-0.18 ( 0.280 )
Week 26 (n=71, 63, 134)	-0.12 ( 0.295 )	-0.13 ( 0.273 )	-0.13 ( 0.284 )
Week 39 (n=68, 53, 121)	-0.14 ( 0.271 )	-0.19 ( 0.290 )	-0.17 ( 0.279 )
Week 52 (n=69, 56, 125)	-0.21 ( 0.291 )	-0.16 ( 0.293 )	-0.19 ( 0.292 )

Notes
[22] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[23] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[24] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study

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End point title

White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study ^[25]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[26]	113 ^[27]	243 ^[28]
Units: cells*10^9/L
arithmetic mean (standard deviation)
Week 6 (n=98, 93, 191)	0.02 ( 1.705 )	0.32 ( 2.120 )	0.17 ( 1.919 )
Week 26 (n=71, 63, 134)	0.12 ( 1.892 )	0.22 ( 2.990 )	0.17 ( 2.460 )
Week 39 (n=69, 53, 122)	0.35 ( 4.014 )	0.38 ( 1.670 )	0.36 ( 3.202 )
Week 52 (n=69, 56, 125)	-0.08 ( 2.027 )	-0.04 ( 1.568 )	-0.06 ( 1.829 )

Notes
[26] - The statistical analysis results are presented in the endpoint data table, per protocol
[27] - The statistical analysis results are presented in the endpoint data table, per protocol
[28] - The statistical analysis results are presented in the endpoint data table, per protocol

No statistical analyses for this end point

Primary: Neutrophils (Hematology): Change From Baseline to End of Study

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End point title

Neutrophils (Hematology): Change From Baseline to End of Study ^[29]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[30]	113 ^[31]	243 ^[32]
Units: cells*10^9/L
arithmetic mean (standard deviation)
Week 6 (n=97, 92, 189)	0.01 ( 1.720 )	0.33 ( 2.102 )	0.17 ( 1.917 )
Week 26 (n=71, 63, 134)	-0.03 ( 1.813 )	143.08 ( 1133.988 )	67.25 ( 777.558 )
Week 39 (n=68, 53, 121)	-0.23 ( 2.380 )	0.18 ( 1.635 )	-0.05 ( 2.089 )
Week 52 (n=69, 56, 125)	-0.14 ( 1.986 )	-0.04 ( 1.498 )	-0.10 ( 1.778 )

Notes
[30] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[31] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[32] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Lymphocytes (Hematology): Change From Baseline to End of Study

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End point title

Lymphocytes (Hematology): Change From Baseline to End of Study ^[33]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[34]	113 ^[35]	243 ^[36]
Units: cells*10^9/L
arithmetic mean (standard deviation)
Week 6 (n=97, 92, 189)	0.06 ( 0.305 )	-0.07 ( 0.326 )	0.00 ( 0.321 )
Week 26 (n=71, 63, 134)	0.09 ( 0.331 )	13.92 ( 110.588 )	6.59 ( 75.823 )
Week 39 (n=68, 53, 121)	0.03 ( 0.394 )	0.04 ( 0.312 )	0.03 ( 0.359 )
Week 52 (n=69, 56, 125)	0.04 ( 0.394 )	-0.05 ( 0.294 )	0.00 ( 0.354 )

Notes
[34] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[35] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[36] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Monocytes (Hematology): Change From Baseline to End of Study

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End point title

Monocytes (Hematology): Change From Baseline to End of Study ^[37]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[38]	113 ^[39]	243 ^[40]
Units: cells*10^9/L
arithmetic mean (standard deviation)
Week 6 (n=96, 92, 188)	0.01 ( 0.127 )	0.01 ( 0.123 )	0.01 ( 0.125 )
Week 26 (n=71, 63, 134)	0.02 ( 0.095 )	17.43 ( 138.498 )	8.21 ( 94.963 )
Week 39 (n=68, 53, 121)	0.02 ( 0.120 )	0.03 ( 0.122 )	0.02 ( 0.120 )
Week 52 (n=69, 56, 125)	0.00 ( 0.109 )	0.01 ( 0.132 )	0.00 ( 0.119 )

Notes
[38] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[39] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[40] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Absolute Platelet Count (Hematology): Change From Baseline to End of Study

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End point title

Absolute Platelet Count (Hematology): Change From Baseline to End of Study ^[41]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[42]	112 ^[43]	242 ^[44]
Units: cells*10^9/L
arithmetic mean (standard deviation)
Week 6 (n=96, 92, 188)	4.59 ( 36.489 )	0.39 ( 40.844 )	2.54 ( 38.635 )
Week 26 (n=71, 62, 133)	-1.68 ( 43.279 )	-10.39 ( 43.757 )	-5.74 ( 43.556 )
Week 39 (n=68, 52, 120)	-3.90 ( 43.848 )	-7.29 ( 49.222 )	-5.37 ( 46.084 )
Week 52 (n=69, 54, 123)	-3.41 ( 41.120 )	-10.63 ( 44.537 )	-6.58 ( 42.628 )

Notes
[42] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[43] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[44] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study

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End point title

Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study ^[45]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[46]	113 ^[47]	243 ^[48]
Units: picograms
arithmetic mean (standard deviation)
Week 6 (n=96, 92, 188)	-0.09 ( 0.822 )	-0.15 ( 0.825 )	-0.12 ( 0.821 )
Week 26 (n=71, 62, 133)	-0.38 ( 1.033 )	0.05 ( 1.078 )	-0.18 ( 1.072 )
Week 39 (n=68, 53, 121)	-0.34 ( 1.205 )	-0.08 ( 0.978 )	-0.22 ( 1.114 )
Week 52 (n=69, 56, 125)	-0.36 ( 1.124 )	-0.07 ( 1.142 )	-0.23 ( 1.137 )

Notes
[46] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[47] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[48] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study

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End point title

Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study ^[49]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	128 ^[50]	113 ^[51]	241 ^[52]
Units: g/L
arithmetic mean (standard deviation)
Week 6 (n=93, 90, 183)	2.15 ( 11.689 )	1.78 ( 10.870 )	1.97 ( 11.264 )
Week 26 (n=69, 60, 129)	-1.30 ( 14.844 )	2.17 ( 15.741 )	0.31 ( 15.306 )
Week 39 (n=61, 53, 114)	-2.13 ( 13.677 )	-2.64 ( 14.826 )	-2.37 ( 14.161 )
Week 52 (n=62, 56, 118)	-0.16 ( 12.609 )	0.18 ( 13.684 )	0.00 ( 13.074 )

Notes
[50] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[51] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[52] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study

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End point title

Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study ^[53]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[54]	113 ^[55]	244 ^[56]
Units: seconds
arithmetic mean (standard deviation)
Week 6 (n=100, 93, 193)	0.03 ( 0.480 )	-0.09 ( 2.556 )	-0.03 ( 1.803 )
Week 26 (n=70, 57, 127)	-0.08 ( 1.026 )	-0.36 ( 3.187 )	-0.20 ( 2.261 )
Week 39 (n=70, 51, 121)	0.10 ( 0.569 )	-0.21 ( 3.396 )	-0.03 ( 2.239 )
Week 52 (n=72, 52, 124)	0.10 ( 0.889 )	-0.22 ( 3.703 )	-0.04 ( 2.483 )

Notes
[54] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[55] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[56] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study

Top of page

End point title

Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study ^[57]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[58]	113 ^[59]	244 ^[60]
Units: seconds
arithmetic mean (standard deviation)
Week 6 (n=100, 93, 193)	-0.27 ( 2.151 )	0.55 ( 2.483 )	0.13 ( 2.347 )
Week 26 (n=70, 57, 127)	-0.02 ( 1.898 )	0.48 ( 1.932 )	0.20 ( 1.922 )
Week 39 (n=70, 51, 121)	0.14 ( 1.556 )	0.67 ( 3.672 )	0.36 ( 2.661 )
Week 52 (n=71, 51, 122)	-0.09 ( 2.156 )	0.88 ( 2.992 )	0.32 ( 2.573 )

Notes
[58] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[59] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[60] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study ^[61]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[62]	113 ^[63]	244 ^[64]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	0.02 ( 1.348 )	-0.01 ( 1.560 )	0.00 ( 1.450 )
Week 26 (n=75, 62, 137)	0.21 ( 1.489 )	0.17 ( 1.600 )	0.19 ( 1.535 )
Week 39 (n=72, 55, 127)	0.41 ( 1.852 )	0.05 ( 1.659 )	0.25 ( 1.773 )
Week 52 (n=74, 56, 130)	0.16 ( 1.836 )	0.15 ( 1.342 )	0.16 ( 1.636 )

Notes
[62] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[63] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[64] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Creatinine (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Creatinine (Clinical Chemistry): Change From Baseline to End of Study ^[65]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[66]	113 ^[67]	244 ^[68]
Units: μmol/L
arithmetic mean (standard deviation)
Week 6 (n=104, 96, 200)	-4.45 ( 9.227 )	-5.67 ( 10.725 )	-5.04 ( 9.968 )
Week 26 (n=75, 63, 138)	-2.71 ( 10.478 )	-4.07 ( 12.074 )	-3.33 ( 11.213 )
Week 39 (n=72, 55, 127)	-1.47 ( 12.414 )	-4.02 ( 10.182 )	-2.58 ( 11.527 )
Week 52 (n=74, 56, 130)	-4.78 ( 11.446 )	-5.21 ( 9.941 )	-4.96 ( 10.785 )

Notes
[66] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[67] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[68] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study ^[69]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[70]	113 ^[71]	244 ^[72]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	2.52 ( 56.209 )	-11.01 ( 94.662 )	-4.01 ( 77.285 )
Week 26 (n=75, 61, 136)	5.61 ( 51.627 )	-15.44 ( 62.435 )	-3.83 ( 57.480 )
Week 39 (n=72, 54, 126)	8.40 ( 96.021 )	-9.67 ( 75.655 )	0.66 ( 88.002 )
Week 52 (n=74, 56, 130)	30.39 ( 125.044 )	-16.55 ( 85.305 )	10.17 ( 111.783 )

Notes
[70] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[71] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[72] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study ^[73]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[74]	113 ^[75]	244 ^[76]
Units: μmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-0.85 ( 3.420 )	-0.15 ( 3.167 )	-0.51 ( 3.311 )
Week 26 (n=75, 61, 136)	-0.43 ( 3.535 )	0.28 ( 2.814 )	-0.11 ( 3.240 )
Week 39 (n=72, 55, 127)	-0.71 ( 2.881 )	0.31 ( 3.754 )	-0.27 ( 3.313 )
Week 52 (n=74, 56, 130)	-0.30 ( 3.673 )	-0.15 ( 3.250 )	-0.24 ( 3.485 )

Notes
[74] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[75] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[76] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study ^[77]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[78]	113 ^[79]	244 ^[80]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-8.94 ( 8.928 )	-11.28 ( 10.053 )	-10.07 ( 9.535 )
Week 26 (n=75, 61, 136)	-8.95 ( 9.869 )	-11.66 ( 11.294 )	-10.16 ( 10.579 )
Week 39 (n=71, 54, 125)	-9.70 ( 9.145 )	-10.09 ( 13.476 )	-9.87 ( 11.175 )
Week 52 (n=73, 56, 129)	-9.37 ( 10.347 )	-12.11 ( 9.947 )	-10.56 ( 10.227 )

Notes
[78] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[79] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[80] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study ^[81]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[82]	113 ^[83]	244 ^[84]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=102, 95, 197)	-1.89 ( 4.881 )	-2.21 ( 6.163 )	-2.05 ( 5.524 )
Week 26 (n=74, 59, 133)	-0.69 ( 8.569 )	-2.56 ( 7.013 )	-1.52 ( 7.943 )
Week 39 (n=72, 54, 126)	-1.38 ( 6.714 )	-1.17 ( 7.036 )	-1.29 ( 6.827 )
Week 52 (n=73, 55, 128)	-0.81 ( 6.576 )	-0.82 ( 7.794 )	-0.81 ( 7.095 )

Notes
[82] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[83] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[84] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study ^[85]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	129 ^[86]	109 ^[87]	238 ^[88]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=93, 89, 182)	-6.57 ( 26.734 )	-8.58 ( 23.626 )	-7.55 ( 25.213 )
Week 26 (n=67, 56, 123)	-1.66 ( 23.894 )	-4.91 ( 23.613 )	-3.14 ( 23.725 )
Week 39 (n=59, 47, 106)	-2.17 ( 25.010 )	-2.02 ( 26.431 )	-2.10 ( 25.526 )
Week 52 (n=71, 47, 118)	0.14 ( 22.788 )	3.32 ( 26.413 )	1.41 ( 24.237 )

Notes
[86] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[87] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[88] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study ^[89]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[90]	113 ^[91]	244 ^[92]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-1.07 ( 9.516 )	-3.13 ( 9.393 )	-2.06 ( 9.489 )
Week 26 (n=75, 62, 137)	-1.47 ( 11.487 )	-5.02 ( 15.370 )	-3.07 ( 13.450 )
Week 39 (n=72, 54, 126)	-1.92 ( 10.860 )	-4.67 ( 12.516 )	-3.10 ( 11.631 )
Week 52 (n=74, 56, 130)	1.69 ( 23.235 )	-3.09 ( 14.538 )	-0.37 ( 20.031 )

Notes
[90] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[91] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[92] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study ^[93]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[94]	113 ^[95]	244 ^[96]
Units: U/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-1.91 ( 12.394 )	-4.56 ( 12.340 )	-3.19 ( 12.408 )
Week 26 (n=75, 63, 138)	1.68 ( 18.995 )	-2.86 ( 14.157 )	-0.39 ( 17.051 )
Week 39 (n=72, 55, 127)	-2.28 ( 12.252 )	-5.02 ( 16.088 )	-3.46 ( 14.049 )
Week 52 (n=74, 56, 130)	0.55 ( 18.637 )	-1.54 ( 13.796 )	-0.35 ( 16.697 )

Notes
[94] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[95] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[96] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Sodium (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Sodium (Clinical Chemistry): Change From Baseline to End of Study ^[97]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[98]	113 ^[99]	244 ^[100]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 95, 198)	-0.52 ( 3.168 )	-1.06 ( 2.592 )	-0.78 ( 2.911 )
Week 26 (n=74, 61, 135)	-0.35 ( 3.173 )	-1.26 ( 2.744 )	-0.76 ( 3.010 )
Week 39 (n=72, 53, 125)	-0.90 ( 2.984 )	-0.68 ( 2.772 )	-0.81 ( 2.887 )
Week 52 (n=73, 56, 129)	-0.55 ( 2.774 )	-0.84 ( 2.164 )	-0.67 ( 2.522 )

Notes
[98] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[99] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[100] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Potassium (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Potassium (Clinical Chemistry): Change From Baseline to End of Study ^[101]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[101] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[102]	113 ^[103]	244 ^[104]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-0.02 ( 0.335 )	-0.08 ( 0.330 )	-0.05 ( 0.333 )
Week 26 (n=74, 61, 135)	0.01 ( 0.367 )	0.00 ( 0.373 )	0.00 ( 0.368 )
Week 39 (n=72, 52, 124)	-0.01 ( 0.389 )	-0.09 ( 0.382 )	-0.04 ( 0.387 )
Week 52 (n=73, 56, 129)	-0.10 ( 0.369 )	-0.03 ( 0.338 )	-0.07 ( 0.357 )

Notes
[102] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[103] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[104] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Calcium (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Calcium (Clinical Chemistry): Change From Baseline to End of Study ^[105]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[105] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[106]	113 ^[107]	244 ^[108]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-0.02 ( 0.079 )	-0.04 ( 0.086 )	-0.03 ( 0.083 )
Week 26 (n=75, 63, 138)	-0.03 ( 0.080 )	-0.04 ( 0.091 )	-0.03 ( 0.085 )
Week 39 (n=72, 55, 127)	-0.04 ( 0.091 )	-0.05 ( 0.087 )	-0.05 ( 0.089 )
Week 52 (n=74, 56, 130)	-0.06 ( 0.084 )	-0.04 ( 0.092 )	-0.05 ( 0.088 )

Notes
[106] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[107] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[108] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study ^[109]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[109] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[110]	113 ^[111]	244 ^[112]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	0.08 ( 0.173 )	0.08 ( 0.168 )	0.08 ( 0.170 )
Week 26 (n=75, 62, 137)	0.09 ( 0.182 )	0.09 ( 0.170 )	0.09 ( 0.176 )
Week 39 (n=72, 55, 127)	0.07 ( 0.165 )	0.08 ( 0.155 )	0.08 ( 0.160 )
Week 52 (n=74, 56, 130)	0.09 ( 0.169 )	0.08 ( 0.172 )	0.08 ( 0.170 )

Notes
[110] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[111] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[112] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Uric Acid (Clinical Chemistry): Change From Baseline to End of Study

Top of page

End point title

Uric Acid (Clinical Chemistry): Change From Baseline to End of Study ^[113]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[113] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[114]	113 ^[115]	244 ^[116]
Units: μmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-28.36 ( 51.219 )	-37.43 ( 37.302 )	-32.73 ( 45.163 )
Week 26 (n=75, 62, 137)	-16.66 ( 60.922 )	-32.91 ( 34.446 )	-24.01 ( 51.163 )
Week 39 (n=72, 55, 127)	-13.55 ( 57.830 )	-35.80 ( 40.965 )	-23.18 ( 52.213 )
Week 52 (n=74, 56, 130)	-15.27 ( 56.459 )	-31.23 ( 29.780 )	-22.15 ( 47.380 )

Notes
[114] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[115] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[116] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study ^[117]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[117] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[118]	113 ^[119]	244 ^[120]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=102, 95, 197)	-0.37 ( 0.688 )	-0.57 ( 0.556 )	-0.47 ( 0.634 )
Week 26 (n=74, 62, 136)	-0.19 ( 0.657 )	-0.31 ( 0.661 )	-0.25 ( 0.659 )
Week 39 (n=72, 53, 125)	-0.33 ( 0.565 )	-0.41 ( 0.552 )	-0.36 ( 0.559 )
Week 52 (n=73, 56, 129)	-0.31 ( 0.660 )	-0.25 ( 0.594 )	-0.29 ( 0.630 )

Notes
[118] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[119] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[120] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Albumin (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Albumin (Clinical Chemistry): Change From Baseline to End of Study ^[121]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[122]	113 ^[123]	244 ^[124]
Units: g/L
arithmetic mean (standard deviation)
Week 6 (n=103, 96, 199)	-1.65 ( 2.782 )	-1.95 ( 2.885 )	-1.79 ( 2.829 )
Week 26 (n=75, 63, 138)	-1.31 ( 2.541 )	-1.14 ( 2.558 )	-1.23 ( 2.541 )
Week 39 (n=72, 55, 127)	-1.75 ( 2.782 )	-1.56 ( 2.507 )	-1.67 ( 2.658 )
Week 52 (n=74, 56, 130)	-1.96 ( 2.949 )	-1.02 ( 3.205 )	-1.55 ( 3.086 )

Notes
[122] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[123] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[124] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Glucose (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Glucose (Clinical Chemistry): Change From Baseline to End of Study ^[125]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[126]	113 ^[127]	244 ^[128]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 97, 200)	-0.39 ( 1.186 )	-0.39 ( 1.438 )	-0.39 ( 1.311 )
Week 26 (n=75, 63, 138)	-0.37 ( 1.271 )	-0.14 ( 1.486 )	-0.27 ( 1.373 )
Week 39 (n=72, 55, 127)	-0.33 ( 1.181 )	-0.60 ( 1.327 )	-0.45 ( 1.249 )
Week 52 (n=74, 56, 130)	-0.32 ( 1.917 )	-0.55 ( 1.479 )	-0.42 ( 1.740 )

Notes
[126] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[127] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[128] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study ^[129]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[130]	113 ^[131]	243 ^[132]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=100, 94, 194)	1.19 ( 2.372 )	0.97 ( 2.518 )	1.09 ( 2.440 )
Week 26 (n=71, 60, 131)	0.77 ( 2.418 )	0.28 ( 2.744 )	0.55 ( 2.574 )
Week 39 (n=67, 50, 117)	0.90 ( 2.240 )	0.63 ( 2.874 )	0.78 ( 2.522 )
Week 52 (n=72, 55, 127)	0.78 ( 2.374 )	0.57 ( 2.304 )	0.69 ( 2.337 )

Notes
[130] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[131] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[132] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Magnesium (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Magnesium (Clinical Chemistry): Change From Baseline to End of Study ^[133]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[134]	113 ^[135]	244 ^[136]
Units: mmol/L
arithmetic mean (standard deviation)
Week 6 (n=103, 95, 198)	-0.03 ( 0.067 )	-0.03 ( 0.058 )	-0.03 ( 0.063 )
Week 26 (n=74, 61, 135)	-0.03 ( 0.064 )	-0.02 ( 0.062 )	-0.02 ( 0.063 )
Week 39 (n=72, 53, 125)	-0.02 ( 0.076 )	-0.01 ( 0.073 )	-0.02 ( 0.075 )
Week 52 (n=73, 56, 129)	-0.03 ( 0.078 )	-0.01 ( 0.057 )	-0.02 ( 0.070 )

Notes
[134] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[135] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[136] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study ^[137]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results. "99999" indicates values that could not be estimated due to low number of participants.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[137] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	1 ^[138]	1 ^[139]	2 ^[140]
Units: mL/sec/1.73m^2
arithmetic mean (standard deviation)
Week 6 (n=1, 1, 2)	-0.08 ( 99999 )	0.00 ( 99999 )	-0.04 ( 0.059 )
Week 26 (n=0, 1, 1)	99999 ( 99999 )	-0.17 ( 99999 )	-0.17 ( 99999 )
Week 39 (n=0, 0, 0)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Week 52 (n=0, 0, 0)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[138] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[139] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[140] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Homocysteine (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Homocysteine (Clinical Chemistry): Change From Baseline to End of Study ^[141]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, and 52

Notes
[141] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[142]	113 ^[143]	244 ^[144]
Units: μmol/L
arithmetic mean (standard deviation)
Week 6 (n=105, 95, 200)	3.07 ( 5.301 )	6.70 ( 11.040 )	4.79 ( 8.692 )
Week 26 (n=76, 61, 137)	4.22 ( 7.549 )	6.69 ( 6.306 )	5.32 ( 7.106 )
Week 52 (n=73, 52, 125)	4.88 ( 6.103 )	7.24 ( 8.687 )	5.86 ( 7.351 )

Notes
[142] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[143] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[144] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study ^[145]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, and 52

Notes
[145] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[146]	113 ^[147]	244 ^[148]
Units: nmol/L
arithmetic mean (standard deviation)
Week 6 (n=104, 94, 198)	0.30 ( 129.306 )	4.68 ( 87.199 )	2.38 ( 111.069 )
Week 26 (n=76, 62, 138)	-4.50 ( 89.013 )	14.10 ( 103.462 )	3.86 ( 95.865 )
Week 52 (n=71, 54, 125)	-0.32 ( 124.059 )	44.30 ( 124.456 )	18.95 ( 125.703 )

Notes
[146] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[147] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[148] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study

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End point title

Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study ^[149]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, and 52

Notes
[149] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[150]	113 ^[151]	244 ^[152]
Units: pmol/L
arithmetic mean (standard deviation)
Week 6 (n=104, 94, 198)	-229.58 ( 1349.008 )	-206.30 ( 2217.016 )	-218.53 ( 1808.859 )
Week 26 (n=76, 63, 139)	-147.38 ( 845.662 )	-143.30 ( 1033.488 )	-145.53 ( 931.955 )
Week 52 (n=74, 54, 128)	-268.44 ( 1684.785 )	-212.84 ( 1096.656 )	-244.98 ( 1460.902 )

Notes
[150] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[151] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[152] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: pH (Urinalysis): Change From Baseline to End of Study

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End point title

pH (Urinalysis): Change From Baseline to End of Study ^[153]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[153] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[154]	113 ^[155]	244 ^[156]
Units: no units
arithmetic mean (standard deviation)
Week 6 (n=98, 88, 186)	0.07 ( 0.601 )	0.19 ( 0.575 )	0.13 ( 0.590 )
Week 26 (n=69, 61, 130)	0.20 ( 0.537 )	0.24 ( 0.560 )	0.22 ( 0.546 )
Week 39 (n=67, 54, 121)	0.13 ( 0.566 )	0.31 ( 0.617 )	0.21 ( 0.594 )
Week 52 (n=71, 56, 127)	0.18 ( 0.682 )	0.20 ( 0.537 )	0.19 ( 0.620 )

Notes
[154] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[155] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[156] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Specific Gravity (Urinalysis): Change From Baseline to End of Study

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End point title

Specific Gravity (Urinalysis): Change From Baseline to End of Study ^[157]

End point description

Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.

End point type

Primary

End point timeframe

Baseline, Weeks 6, 26, 39, and 52

Notes
[157] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[158]	113 ^[159]	244 ^[160]
Units: No units
arithmetic mean (standard deviation)
Week 6 (n=98, 88, 186)	0.00 ( 0.009 )	0.00 ( 0.007 )	0.00 ( 0.008 )
Week 26 (n=69, 61, 130)	0.00 ( 0.009 )	0.00 ( 0.009 )	0.00 ( 0.009 )
Week 39 (n=68, 54, 122)	0.00 ( 0.009 )	0.00 ( 0.009 )	0.00 ( 0.009 )
Week 52 (n=71, 56, 127)	0.00 ( 0.010 )	0.00 ( 0.009 )	0.00 ( 0.009 )

Notes
[158] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[159] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[160] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study

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End point title

Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study ^[161]

End point description

Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Notes
[161] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	128 ^[162]	112 ^[163]	240 ^[164]
Units: mmHg
arithmetic mean (standard deviation)
Week 1- orthostatic (n=119, 106, 225)	-1.5 ( 12.00 )	3.5 ( 16.01 )	0.9 ( 14.22 )
Week 6- orthostatic (n=97, 89, 186)	-1.5 ( 11.85 )	2.6 ( 17.33 )	0.5 ( 14.83 )
Week 26- orthostatic (n=69, 61, 130)	-2.4 ( 16.25 )	-0.3 ( 14.38 )	-1.4 ( 15.38 )
Week 52- orthostatic (n=70, 58, 128)	-1.3 ( 14.59 )	0.7 ( 13.75 )	-0.4 ( 14.19 )
Week 1- standing (n=122, 106, 228)	-2.3 ( 17.05 )	-1.3 ( 25.50 )	-1.9 ( 21.35 )
Week 6- standing (n=99, 90, 189)	-2.9 ( 18.32 )	-3.1 ( 25.89 )	-3.0 ( 22.19 )
Week 26- standing (n=71, 61, 132)	-4.7 ( 19.23 )	-4.0 ( 21.01 )	-4.4 ( 20.00 )
Week 52- standing (n=72, 58, 130)	-3.9 ( 19.81 )	-1.5 ( 20.91 )	-2.8 ( 20.26 )
Week 2- supine (n=121, 109, 230)	-1.0 ( 16.75 )	-4.5 ( 21.94 )	-2.7 ( 19.42 )
Week 4- supine (n=99, 89, 188)	-1.2 ( 16.67 )	-6.7 ( 22.99 )	-3.8 ( 20.05 )
Week 13- supine (n=29, 17, 46)	-4.0 ( 18.34 )	-1.8 ( 24.89 )	-3.2 ( 20.75 )
Week 39- supine (n=77, 66, 143)	-1.7 ( 19.12 )	-1.8 ( 22.08 )	-1.7 ( 20.47 )

Notes
[162] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[163] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[164] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study

Top of page

End point title

Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study ^[165]

End point description

End point type

Primary

End point timeframe

Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Notes
[165] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	128 ^[166]	112 ^[167]	240 ^[168]
Units: mmHg
arithmetic mean (standard deviation)
Week 1- orthostatic (n=119, 106, 225)	-1.9 ( 10.61 )	-0.7 ( 13.27 )	-1.3 ( 11.92 )
Week 6- orthostatic (n=97, 89, 186)	0.0 ( 10.91 )	-0.6 ( 10.00 )	-0.3 ( 10.46 )
Week 26- orthostatic (n=69, 61, 130)	-1.7 ( 12.99 )	0.3 ( 10.16 )	-0.7 ( 11.75 )
Week 52- orthostatic (n=70, 58, 128)	-1.5 ( 10.44 )	0.8 ( 11.42 )	-0.4 ( 10.91 )
Week 1- standing (n=122, 106, 228)	-2.6 ( 12.00 )	-2.1 ( 13.87 )	-2.4 ( 12.88 )
Week 6- standing (n=99, 90, 189)	-0.8 ( 12.27 )	-2.2 ( 14.76 )	-1.5 ( 13.50 )
Week 26- standing (n=71, 61, 132)	-4.0 ( 12.20 )	-1.2 ( 14.67 )	-2.7 ( 13.42 )
Week 52- standing (n=72, 58, 130)	-1.7 ( 12.55 )	1.1 ( 12.01 )	-0.4 ( 12.34 )
Week 2- supine (n=121, 109, 230)	-1.1 ( 12.46 )	-1.3 ( 13.46 )	-1.2 ( 12.91 )
Week 4- supine (n=99, 89, 188)	-1.4 ( 12.06 )	-2.1 ( 12.80 )	-1.7 ( 12.38 )
Week 13- supine (n=29, 17, 46)	-2.6 ( 12.52 )	-0.5 ( 9.59 )	-1.8 ( 11.46 )
Week 39- supine (n=77, 66, 143)	0.2 ( 12.16 )	0.2 ( 12.77 )	0.2 ( 12.40 )

Notes
[166] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[167] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[168] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study

Top of page

End point title

Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study ^[169]

End point description

Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.

End point type

Primary

End point timeframe

Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)

Notes
[169] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	128 ^[170]	112 ^[171]	240 ^[172]
Units: beats/minute
arithmetic mean (standard deviation)
Week 1- orthostatic (n=119, 106, 225)	-1.5 ( 8.49 )	-1.8 ( 10.49 )	-1.6 ( 9.46 )
Week 6- orthostatic (n=97, 89, 186)	-0.5 ( 10.86 )	0.2 ( 10.16 )	-0.1 ( 10.51 )
Week 26- orthostatic (n=69, 61, 130)	-0.9 ( 8.90 )	0.3 ( 9.32 )	-0.4 ( 9.08 )
Week 52- orthostatic (n=70, 58, 128)	0.5 ( 9.72 )	-0.5 ( 8.55 )	0.0 ( 9.19 )
Week 1- standing (n=122, 106, 228)	-5.1 ( 11.43 )	-2.6 ( 12.50 )	-3.9 ( 11.98 )
Week 6- standing (n=99, 90, 189)	-3.1 ( 12.45 )	-3.0 ( 12.23 )	-3.1 ( 12.31 )
Week 26- standing (n=71, 61, 132)	-2.9 ( 12.29 )	-2.4 ( 12.43 )	-2.7 ( 12.31 )
Week 52- standing (n=72, 58, 130)	-3.8 ( 12.88 )	-4.3 ( 11.56 )	-4.0 ( 12.27 )
Week 2- supine (n=121, 109, 230)	-3.3 ( 10.05 )	-0.6 ( 11.10 )	-2.0 ( 10.62 )
Week 4- supine (n=99, 89, 188)	-2.6 ( 10.06 )	-3.3 ( 12.60 )	-3.0 ( 11.31 )
Week 13- supine (n=29, 17, 46)	1.1 ( 11.72 )	-4.8 ( 7.60 )	-1.1 ( 10.68 )
Week 39- supine (n=77, 66, 143)	-3.7 ( 11.76 )	-3.2 ( 11.16 )	-3.4 ( 11.45 )

Notes
[170] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[171] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[172] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Main Heart Rate: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Main Heart Rate: Change From Baseline to End of Study ^[173]

End point description

12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[173] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[174]	113 ^[175]	244 ^[176]
Units: beats/minute
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	2.1 ( 9.51 )	2.2 ( 9.76 )	2.1 ( 9.61 )
Week 6 (n=100, 88, 188)	-2.3 ( 8.60 )	-2.2 ( 10.28 )	-2.2 ( 9.40 )
Week 52 (n=73, 58, 131)	-3.7 ( 9.51 )	-0.7 ( 11.36 )	-2.3 ( 10.44 )

Notes
[174] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[175] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[176] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study ^[177]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[177] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	130 ^[178]	107 ^[179]	237 ^[180]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=125, 105, 230)	0.4 ( 14.08 )	-0.1 ( 13.76 )	0.2 ( 13.91 )
Week 6 (n=99, 84, 183)	0.5 ( 13.97 )	1.1 ( 16.84 )	0.8 ( 15.31 )
Week 52 (n=72, 54, 126)	1.5 ( 12.48 )	-5.8 ( 20.54 )	-1.6 ( 16.75 )

Notes
[178] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[179] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[180] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study ^[181]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[181] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[182]	113 ^[183]	244 ^[184]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	-2.3 ( 7.32 )	-0.8 ( 8.41 )	-1.6 ( 7.87 )
Week 6 (n=100, 88, 188)	-0.5 ( 8.32 )	1.6 ( 8.96 )	0.5 ( 8.67 )
Week 52 (n=72, 58, 130)	-0.2 ( 6.85 )	0.9 ( 7.29 )	0.3 ( 7.04 )

Notes
[182] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[183] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[184] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study ^[185]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[185] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[186]	113 ^[187]	244 ^[188]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	-5.3 ( 20.72 )	-4.2 ( 23.99 )	-4.8 ( 22.27 )
Week 6 (n=99, 88, 187)	6.4 ( 20.96 )	6.4 ( 24.61 )	6.4 ( 22.69 )
Week 52 (n=72, 58, 130)	9.8 ( 24.66 )	4.3 ( 26.24 )	7.3 ( 25.42 )

Notes
[186] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[187] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[188] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study ^[189]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[189] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[190]	113 ^[191]	244 ^[192]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	1.2 ( 17.96 )	2.0 ( 17.21 )	1.6 ( 17.58 )
Week 6 (n=99, 88, 187)	1.0 ( 19.91 )	0.6 ( 18.34 )	0.8 ( 19.14 )
Week 52 (n=72, 58, 130)	-0.1 ( 20.84 )	2.1 ( 18.33 )	0.9 ( 19.72 )

Notes
[190] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[191] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[192] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study ^[193]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[193] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[194]	113 ^[195]	244 ^[196]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	-1.0 ( 14.03 )	-0.2 ( 15.75 )	-0.6 ( 14.84 )
Week 6 (n=99, 88, 187)	3.1 ( 16.49 )	2.6 ( 15.63 )	2.9 ( 16.05 )
Week 52 (n=72, 58, 130)	3.4 ( 18.05 )	2.9 ( 15.40 )	3.2 ( 16.86 )

Notes
[194] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[195] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[196] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Primary: Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study

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End point title

Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study ^[197]

End point description

End point type

Primary

End point timeframe

Baseline, Day 1 (postdose), Weeks 6 and 52

Notes
[197] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The statistical analysis results are presented in the endpoint data table, per protocol

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[198]	113 ^[199]	244 ^[200]
Units: milliseconds
arithmetic mean (standard deviation)
Day 1 (postdose) (n=126, 111, 237)	-30.7 ( 122.48 )	-28.3 ( 113.02 )	-29.6 ( 117.90 )
Week 6 (n=100, 88, 188)	22.6 ( 112.51 )	26.1 ( 129.35 )	24.2 ( 120.37 )
Week 52 (n=73, 58, 131)	41.8 ( 122.96 )	9.4 ( 141.91 )	27.5 ( 132.15 )

Notes
[198] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[199] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data
[200] - Safety Analysis Set: all participants who received any ABBV-951 infusion with available data

No statistical analyses for this end point

Secondary: Average Daily Normalized "Off" Time: Change From Baseline to End of Study

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End point title

Average Daily Normalized "Off" Time: Change From Baseline to End of Study

End point description

Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson’s Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	126 ^[201]	110 ^[202]	236 ^[203]
Units: hours
arithmetic mean (standard deviation)
Week 1 (n=120, 105, 225)	-2.04 ( 3.51 )	-1.84 ( 3.88 )	-1.95 ( 3.68 )
Week 6 (n=110, 95, 205)	-2.43 ( 3.66 )	-2.36 ( 3.56 )	-2.40 ( 3.61 )
Week 13 (n=63, 51, 114)	-2.50 ( 3.83 )	-2.34 ( 3.57 )	-2.43 ( 3.70 )
Week 26 (n=69, 62, 131)	-3.31 ( 3.36 )	-3.38 ( 3.15 )	-3.35 ( 3.25 )
Week 39 (n=68, 54, 122)	-3.25 ( 3.43 )	-3.52 ( 2.92 )	-3.37 ( 3.21 )
Week 52 (n=62, 54, 116)	-3.43 ( 3.16 )	-3.59 ( 3.11 )	-3.51 ( 3.12 )

Attachments

Average Daily Normalized Off Time

Notes
[201] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[202] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[203] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study

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End point title

Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study

End point description

Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson’s Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	126 ^[204]	110 ^[205]	236 ^[206]
Units: hours
arithmetic mean (standard deviation)
Week 1 (n=120, 105, 225)	-0.00 ( 2.10 )	0.11 ( 1.64 )	0.05 ( 1.89 )
Week 6 (n=110, 95, 205)	-0.56 ( 1.95 )	-0.23 ( 1.05 )	-0.41 ( 1.60 )
Week 13 (n=63, 51, 114)	-0.60 ( 1.72 )	-0.38 ( 1.04 )	-0.50 ( 1.45 )
Week 26 (n=69, 62, 131)	-0.61 ( 1.95 )	-0.27 ( 1.73 )	-0.45 ( 1.85 )
Week 39 (n=68, 54, 122)	-0.49 ( 1.07 )	-0.17 ( 1.59 )	-0.35 ( 1.33 )
Week 52 (n=62, 54, 116)	-0.64 ( 1.73 )	0.17 ( 2.53 )	-0.27 ( 2.16 )

Attachments

Average Daily Normalized On Time With TD

Notes
[204] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[205] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[206] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study

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End point title

Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study

End point description

Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson’s Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	126 ^[207]	110 ^[208]	236 ^[209]
Units: hours
arithmetic mean (standard deviation)
Week 1 (n=120, 105, 225)	2.04 ( 3.55 )	1.74 ( 4.04 )	1.90 ( 3.78 )
Week 6 (n=110, 95, 205)	2.99 ( 3.60 )	2.60 ( 3.58 )	2.81 ( 3.59 )
Week 13 (n=63, 51, 114)	3.10 ( 3.32 )	2.72 ( 3.68 )	2.93 ( 3.48 )
Week 26 (n=69, 62, 131)	3.92 ( 3.76 )	3.65 ( 3.31 )	3.79 ( 3.55 )
Week 39 (n=68, 54, 122)	3.74 ( 3.40 )	3.69 ( 3.32 )	3.71 ( 3.35 )
Week 52 (n=62, 54, 116)	4.08 ( 3.28 )	3.43 ( 3.28 )	3.77 ( 3.28 )

Attachments

Average Daily Normalized On Time Without TD

Notes
[207] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[208] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[209] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study

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End point title

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study

End point description

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson’s Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[210]	113 ^[211]	244 ^[212]
Units: units on a scale
arithmetic mean (standard deviation)
Day 2 (n=120, 102, 222)	-2.6 ( 4.28 )	-1.8 ( 3.61 )	-2.3 ( 4.00 )
Week 1 (n=120, 106, 226)	-2.6 ( 5.84 )	-3.3 ( 5.50 )	-2.9 ( 5.68 )
Week 2 (n=117, 95, 212)	-2.5 ( 5.29 )	-2.1 ( 5.10 )	-2.3 ( 5.20 )
Week 3 (n=107, 96, 203)	-2.3 ( 5.65 )	-2.9 ( 5.91 )	-2.6 ( 5.77 )
Week 4 (n=109, 94, 203)	-1.7 ( 6.22 )	-3.0 ( 5.42 )	-2.3 ( 5.88 )
Week 6 (n=104, 89, 193)	-1.1 ( 7.00 )	-1.7 ( 5.15 )	-1.4 ( 6.21 )
Week 13 (n=93, 77, 170)	-1.8 ( 5.80 )	-1.7 ( 5.59 )	-1.7 ( 5.69 )
Week 26 (n=79, 69, 148)	-1.1 ( 5.01 )	-0.7 ( 5.88 )	-0.9 ( 5.42 )
Week 39 (n=75, 60, 135)	-0.7 ( 5.64 )	0.1 ( 6.00 )	-0.4 ( 5.80 )
Week 52 (n=75, 58, 133)	-0.5 ( 5.30 )	-1.3 ( 6.22 )	-0.9 ( 5.71 )

Attachments

MDS-UPDRS Part I Score

Notes
[210] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[211] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[212] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study

Top of page

End point title

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study

End point description

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson’s Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[213]	113 ^[214]	244 ^[215]
Units: units on a scale
arithmetic mean (standard deviation)
Day 2 (n=120, 102, 222)	-2.8 ( 4.55 )	-1.2 ( 4.25 )	-2.1 ( 4.47 )
Week 1 (n=120, 106, 226)	-3.6 ( 4.98 )	-3.9 ( 5.85 )	-3.7 ( 5.40 )
Week 2 (n=117, 95, 212)	-3.3 ( 6.06 )	-3.4 ( 6.53 )	-3.3 ( 6.26 )
Week 3 (n=107, 96, 203)	-3.5 ( 5.83 )	-3.9 ( 6.63 )	-3.7 ( 6.21 )
Week 4 (n=109, 84, 203)	-2.6 ( 5.50 )	-4.9 ( 6.32 )	-3.7 ( 5.98 )
Week 6 (n=104, 89, 193)	-2.5 ( 6.60 )	-4.2 ( 6.09 )	-3.3 ( 6.41 )
Week 13 (n=93, 77, 170)	-3.2 ( 6.44 )	-4.3 ( 6.57 )	-3.7 ( 6.50 )
Week 26 (n=79, 69, 148)	-2.6 ( 6.27 )	-3.9 ( 7.05 )	-3.2 ( 6.65 )
Week 39 (n=75, 60, 135)	-2.6 ( 6.32 )	-4.0 ( 6.93 )	-3.2 ( 6.61 )
Week 52 (n=75, 58, 133)	-2.1 ( 6.94 )	-4.5 ( 7.07 )	-3.2 ( 7.07 )

Attachments

MDS-UPDRS Part II Score

Notes
[213] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[214] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[215] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study

Top of page

End point title

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study

End point description

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson’s Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[216]	113 ^[217]	244 ^[218]
Units: units on a scale
arithmetic mean (standard deviation)
Day 2 (n=120, 102, 222)	-0.6 ( 8.45 )	-0.8 ( 9.20 )	-0.7 ( 8.78 )
Week 1 (n=119, 106, 225)	2.0 ( 11.55 )	3.8 ( 11.00 )	2.8 ( 11.31 )
Week 2 (n=117, 94, 211)	4.1 ( 13.02 )	1.4 ( 10.93 )	2.9 ( 12.18 )
Week 3 (n=107, 96, 203)	3.9 ( 11.98 )	2.2 ( 12.07 )	3.1 ( 12.02 )
Week 4 (n=107, 93, 200)	2.7 ( 12.84 )	0.0 ( 10.97 )	1.5 ( 12.05 )
Week 6 (n=104, 89, 193)	2.4 ( 13.74 )	-0.7 ( 9.58 )	0.9 ( 12.07 )
Week 13 (n=89, 70, 159)	1.4 ( 13.79 )	-1.6 ( 11.82 )	0.1 ( 13.01 )
Week 26 (n=75, 64, 139)	1.4 ( 12.71 )	0.1 ( 11.61 )	0.8 ( 12.19 )
Week 39 (n=75, 55, 130)	1.9 ( 12.70 )	2.3 ( 13.26 )	2.1 ( 12.89 )
Week 52 (n=75, 58, 133)	1.8 ( 12.53 )	1.7 ( 13.02 )	1.7 ( 12.69 )

Attachments

MDS-UPDRS Part III Score

Notes
[216] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[217] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[218] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study

Top of page

End point title

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study

End point description

The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson’s Disease (PD). Part IV assesses the participant’s motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.

End point type

Secondary

End point timeframe

Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[219]	113 ^[220]	244 ^[221]
Units: units on a scale
arithmetic mean (standard deviation)
Day 2 (n=117, 101, 218)	-1.8 ( 3.57 )	-1.1 ( 3.45 )	-1.5 ( 3.52 )
Week 1 (n=117, 105, 222)	-1.7 ( 3.86 )	-1.7 ( 4.10 )	-1.7 ( 3.96 )
Week 2 (n=115, 93, 208)	-2.5 ( 3.58 )	-2.3 ( 3.56 )	-2.4 ( 3.57 )
Week 3 (n=102, 96, 198)	-2.1 ( 4.06 )	-2.3 ( 3.74 )	-2.2 ( 3.90 )
Week 4 (n=106, 94, 200)	-3.0 ( 3.69 )	-2.6 ( 3.78 )	-2.8 ( 3.73 )
Week 6 (n=101, 89, 190)	-2.6 ( 3.34 )	-2.8 ( 3.90 )	-2.7 ( 3.61 )
Week 13 (n=89, 77, 166)	-3.7 ( 3.47 )	-3.3 ( 4.04 )	-3.5 ( 3.74 )
Week 26 (n=77, 69, 146)	-3.5 ( 3.43 )	-3.5 ( 4.12 )	-3.5 ( 3.76 )
Week 39 (n=73, 59, 132)	-3.5 ( 4.06 )	-3.5 ( 4.11 )	-3.5 ( 4.07 )
Week 52 (n=72, 58, 130)	-4.1 ( 3.75 )	-3.8 ( 4.71 )	-3.9 ( 4.19 )

Attachments

MDS-UPDRS Part IV Score

Notes
[219] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[220] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[221] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study

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End point title

Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study

End point description

The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson’s Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.

End point type

Secondary

End point timeframe

Baseline, Weeks 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[222]	112 ^[223]	243 ^[224]
Units: units on a scale
arithmetic mean (standard deviation)
Week 6 (n=105, 91, 196)	-5.0 ( 11.39 )	-7.3 ( 8.81 )	-6.1 ( 10.31 )
Week 13 (n=93, 77, 170)	-6.9 ( 10.76 )	-8.2 ( 8.89 )	-7.5 ( 9.94 )
Week 26 (n=80, 69, 149)	-5.0 ( 13.06 )	-8.4 ( 8.07 )	-6.6 ( 11.12 )
Week 39 (n=76, 61, 137)	-7.0 ( 11.19 )	-7.2 ( 9.21 )	-7.1 ( 10.32 )
Week 52 (n=74, 57, 131)	-6.5 ( 12.34 )	-8.7 ( 8.19 )	-7.5 ( 10.75 )

Attachments

Sleep Symptoms as Assessed by PDSS-2 Total Score

Notes
[222] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[223] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[224] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study

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End point title

Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study

End point description

The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson’s Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.

End point type

Secondary

End point timeframe

Baseline, Weeks 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	131 ^[225]	112 ^[226]	243 ^[227]
Units: units on a scale
arithmetic mean (standard deviation)
Week 6 (n=105, 91, 196)	-7.0 ( 14.53 )	-8.4 ( 10.53 )	-7.6 ( 12.81 )
Week 13 (n=93, 77, 170)	-8.3 ( 15.33 )	-8.2 ( 11.18 )	-8.3 ( 13.57 )
Week 26 (n=79, 69, 148)	-7.4 ( 13.00 )	-7.1 ( 12.27 )	-7.3 ( 12.62 )
Week 39 (n=76, 61, 137)	-7.8 ( 13.81 )	-7.5 ( 13.58 )	-7.7 ( 13.66 )
Week 52 (n=75, 57, 132)	-7.2 ( 14.65 )	-7.2 ( 12.35 )	-7.2 ( 13.65 )

Attachments

QoL Assessed by PDQ-39 Summary Index Score

Notes
[225] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[226] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[227] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Secondary: The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study

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End point title

The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study

End point description

The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant’s current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.

End point type

Secondary

End point timeframe

Baseline, Weeks 6, 13, 26, 39, and 52

End point values	ABBV-951 Low Dose Subgroup	ABBV-951 High Dose Subgroup	ABBV-951 All Participants
Number of subjects analysed	125 ^[228]	104 ^[229]	229 ^[230]
Units: units on a scale
arithmetic mean (standard deviation)
Week 6 (n=93, 82, 175)	0.060 ( 0.1921 )	0.113 ( 0.1780 )	0.085 ( 0.1870 )
Week 13 (n=80, 66, 146)	0.064 ( 0.2153 )	0.122 ( 0.1984 )	0.090 ( 0.2092 )
Week 26 (n=70, 58, 128)	0.074 ( 0.1771 )	0.122 ( 0.1803 )	0.096 ( 0.1795 )
Week 39 (n=72, 49, 121)	0.075 ( 0.1842 )	0.129 ( 0.1995 )	0.097 ( 0.1916 )
Week 52 (n=70, 52, 122)	0.076 ( 0.2062 )	0.126 ( 0.2213 )	0.097 ( 0.2134 )

Attachments

EQ-5D-5L Quality of Life Summary Index

Notes
[228] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[229] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM
[230] - FAS: participants receiving any infusion and had a BL and tx observation for at least 1 efficacy OM

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-cause mortality is reported from enrollment to end of study; median time on follow-up was 367.0 days for the ABBV-951 Low Dose Subgroup, the ABBV-951 High Dose Subgroup, and the ABBV-951 All Participants group.

Adverse event reporting additional description

TEAEs and SAEs were collected from first dose of study drug until 30 days after the last infusion; mean time on treatment was 244.9 days for the ABBV-951 Low Dose Subgroup, 240.6 days for the ABBV-951 High Dose Subgroup, and 242.9 days for the ABBV-951 All Participants group.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

ABBV-951 Low Dose Subgroup

Reporting group description

Reporting group title

ABBV-951 All Participants

Reporting group description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period.

Reporting group title

ABBV-951 High Dose Subgroup

Reporting group description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Serious adverse events	ABBV-951 Low Dose Subgroup	ABBV-951 All Participants	ABBV-951 High Dose Subgroup
Total subjects affected by serious adverse events
subjects affected / exposed	32 / 131 (24.43%)	63 / 244 (25.82%)	31 / 113 (27.43%)
number of deaths (all causes)	0	5	5
number of deaths resulting from adverse events	0	3	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
ORTHOSTATIC HYPOTENSION
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HAEMORRHAGE
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HAEMATOMA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CHEST DISCOMFORT
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CHEST PAIN
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HYPOTHERMIA
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFUSION SITE HAEMATOMA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFUSION SITE INJURY
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DYSPNOEA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
BRONCHIECTASIS
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HYPERVENTILATION
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
DOPAMINE DYSREGULATION SYNDROME
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DELUSIONAL DISORDER, UNSPECIFIED TYPE
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DELUSION
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DELIRIUM
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CONFUSIONAL STATE
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ANXIETY
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HALLUCINATION
subjects affected / exposed	6 / 131 (4.58%)	7 / 244 (2.87%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	5 / 6	6 / 7	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PSYCHOTIC DISORDER
subjects affected / exposed	4 / 131 (3.05%)	6 / 244 (2.46%)	2 / 113 (1.77%)
occurrences causally related to treatment / all	5 / 5	7 / 7	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SUICIDE ATTEMPT
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
BLOOD SODIUM DECREASED
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
FACE INJURY
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
FALL
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SUBDURAL HAEMATOMA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
Cardiac disorders
CORONARY ARTERY DISEASE
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CARDIO-RESPIRATORY ARREST
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
CARDIAC ARREST
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ACUTE MYOCARDIAL INFARCTION
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
CEREBRAL MASS EFFECT
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1
COGNITIVE DISORDER
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DIZZINESS
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DYSARTHRIA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
DYSTONIA
subjects affected / exposed	0 / 131 (0.00%)	2 / 244 (0.82%)	2 / 113 (1.77%)
occurrences causally related to treatment / all	0 / 0	2 / 3	2 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PARKINSON'S DISEASE
subjects affected / exposed	5 / 131 (3.82%)	6 / 244 (2.46%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	2 / 6	2 / 7	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PARAESTHESIA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PARKINSONISM
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PSYCHOGENIC SEIZURE
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
GENERALISED TONIC-CLONIC SEIZURE
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HEMIANAESTHESIA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HEMIPARESIS
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LOSS OF CONSCIOUSNESS
subjects affected / exposed	1 / 131 (0.76%)	2 / 244 (0.82%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	1 / 1	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
LUMBOSACRAL RADICULOPATHY
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ON AND OFF PHENOMENON
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
PERIORBITAL PAIN
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PERIORBITAL SWELLING
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
COLITIS ISCHAEMIC
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INTESTINAL HAEMORRHAGE
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
ARTHRITIS REACTIVE
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
RHABDOMYOLYSIS
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SACROILIAC JOINT DYSFUNCTION
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
INFUSION SITE CELLULITIS
subjects affected / exposed	4 / 131 (3.05%)	10 / 244 (4.10%)	6 / 113 (5.31%)
occurrences causally related to treatment / all	4 / 4	9 / 10	5 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFUSION SITE INFECTION
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	2 / 131 (1.53%)	3 / 244 (1.23%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEPSIS
subjects affected / exposed	3 / 131 (2.29%)	3 / 244 (1.23%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	2 / 3	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
SEPTIC SHOCK
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
URINARY TRACT INFECTION
subjects affected / exposed	2 / 131 (1.53%)	4 / 244 (1.64%)	2 / 113 (1.77%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
INFUSION SITE ABSCESS
subjects affected / exposed	5 / 131 (3.82%)	8 / 244 (3.28%)	3 / 113 (2.65%)
occurrences causally related to treatment / all	5 / 5	9 / 10	4 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
CELLULITIS
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
ABSCESS LIMB
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
PAROTID ABSCESS
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
DEHYDRATION
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HYPOKALAEMIA
subjects affected / exposed	0 / 131 (0.00%)	1 / 244 (0.41%)	1 / 113 (0.88%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
HYPONATRAEMIA
subjects affected / exposed	1 / 131 (0.76%)	1 / 244 (0.41%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	ABBV-951 Low Dose Subgroup	ABBV-951 All Participants	ABBV-951 High Dose Subgroup
Total subjects affected by non serious adverse events
subjects affected / exposed	111 / 131 (84.73%)	218 / 244 (89.34%)	107 / 113 (94.69%)
Investigations
WEIGHT DECREASED
subjects affected / exposed	10 / 131 (7.63%)	24 / 244 (9.84%)	14 / 113 (12.39%)
occurrences all number	10	24	14
VITAMIN B6 DECREASED
subjects affected / exposed	5 / 131 (3.82%)	11 / 244 (4.51%)	6 / 113 (5.31%)
occurrences all number	5	11	6
Injury, poisoning and procedural complications
SKIN LACERATION
subjects affected / exposed	1 / 131 (0.76%)	7 / 244 (2.87%)	6 / 113 (5.31%)
occurrences all number	1	7	6
FALL
subjects affected / exposed	16 / 131 (12.21%)	39 / 244 (15.98%)	23 / 113 (20.35%)
occurrences all number	42	77	35
CONTUSION
subjects affected / exposed	2 / 131 (1.53%)	8 / 244 (3.28%)	6 / 113 (5.31%)
occurrences all number	3	12	9
Vascular disorders
ORTHOSTATIC HYPOTENSION
subjects affected / exposed	6 / 131 (4.58%)	12 / 244 (4.92%)	6 / 113 (5.31%)
occurrences all number	6	13	7
Nervous system disorders
SOMNOLENCE
subjects affected / exposed	9 / 131 (6.87%)	12 / 244 (4.92%)	3 / 113 (2.65%)
occurrences all number	11	14	3
PARKINSON'S DISEASE
subjects affected / exposed	7 / 131 (5.34%)	11 / 244 (4.51%)	4 / 113 (3.54%)
occurrences all number	8	12	4
HEADACHE
subjects affected / exposed	7 / 131 (5.34%)	14 / 244 (5.74%)	7 / 113 (6.19%)
occurrences all number	7	17	10
DIZZINESS
subjects affected / exposed	14 / 131 (10.69%)	24 / 244 (9.84%)	10 / 113 (8.85%)
occurrences all number	18	28	10
DYSKINESIA
subjects affected / exposed	12 / 131 (9.16%)	18 / 244 (7.38%)	6 / 113 (5.31%)
occurrences all number	20	27	7
General disorders and administration site conditions
INFUSION SITE PAIN
subjects affected / exposed	18 / 131 (13.74%)	38 / 244 (15.57%)	20 / 113 (17.70%)
occurrences all number	41	68	27
INFUSION SITE OEDEMA
subjects affected / exposed	19 / 131 (14.50%)	47 / 244 (19.26%)	28 / 113 (24.78%)
occurrences all number	78	123	45
INFUSION SITE NODULE
subjects affected / exposed	36 / 131 (27.48%)	70 / 244 (28.69%)	34 / 113 (30.09%)
occurrences all number	65	123	58
INFUSION SITE INFLAMMATION
subjects affected / exposed	3 / 131 (2.29%)	9 / 244 (3.69%)	6 / 113 (5.31%)
occurrences all number	3	12	9
INFUSION SITE HAEMATOMA
subjects affected / exposed	10 / 131 (7.63%)	17 / 244 (6.97%)	7 / 113 (6.19%)
occurrences all number	10	22	12
INFUSION SITE ERYTHEMA
subjects affected / exposed	64 / 131 (48.85%)	127 / 244 (52.05%)	63 / 113 (55.75%)
occurrences all number	175	343	168
INFUSION SITE BRUISING
subjects affected / exposed	10 / 131 (7.63%)	18 / 244 (7.38%)	8 / 113 (7.08%)
occurrences all number	15	30	15
INFUSION SITE PAPULE
subjects affected / exposed	7 / 131 (5.34%)	18 / 244 (7.38%)	11 / 113 (9.73%)
occurrences all number	8	26	18
INFUSION SITE EXTRAVASATION
subjects affected / exposed	8 / 131 (6.11%)	20 / 244 (8.20%)	12 / 113 (10.62%)
occurrences all number	10	25	15
INFUSION SITE REACTION
subjects affected / exposed	13 / 131 (9.92%)	30 / 244 (12.30%)	17 / 113 (15.04%)
occurrences all number	26	62	36
INJECTION SITE ERYTHEMA
subjects affected / exposed	6 / 131 (4.58%)	14 / 244 (5.74%)	8 / 113 (7.08%)
occurrences all number	22	36	14
INJECTION SITE NODULE
subjects affected / exposed	3 / 131 (2.29%)	9 / 244 (3.69%)	6 / 113 (5.31%)
occurrences all number	15	23	8
INJECTION SITE PAIN
subjects affected / exposed	2 / 131 (1.53%)	8 / 244 (3.28%)	6 / 113 (5.31%)
occurrences all number	2	8	6
Gastrointestinal disorders
NAUSEA
subjects affected / exposed	8 / 131 (6.11%)	19 / 244 (7.79%)	11 / 113 (9.73%)
occurrences all number	11	24	13
CONSTIPATION
subjects affected / exposed	8 / 131 (6.11%)	20 / 244 (8.20%)	12 / 113 (10.62%)
occurrences all number	8	20	12
Psychiatric disorders
ANXIETY
subjects affected / exposed	10 / 131 (7.63%)	28 / 244 (11.48%)	18 / 113 (15.93%)
occurrences all number	12	34	22
HALLUCINATION, VISUAL
subjects affected / exposed	10 / 131 (7.63%)	15 / 244 (6.15%)	5 / 113 (4.42%)
occurrences all number	14	20	6
HALLUCINATION
subjects affected / exposed	14 / 131 (10.69%)	35 / 244 (14.34%)	21 / 113 (18.58%)
occurrences all number	22	49	27
DELUSION
subjects affected / exposed	7 / 131 (5.34%)	8 / 244 (3.28%)	1 / 113 (0.88%)
occurrences all number	8	9	1
INSOMNIA
subjects affected / exposed	9 / 131 (6.87%)	18 / 244 (7.38%)	9 / 113 (7.96%)
occurrences all number	9	18	9
Musculoskeletal and connective tissue disorders
BACK PAIN
subjects affected / exposed	8 / 131 (6.11%)	13 / 244 (5.33%)	5 / 113 (4.42%)
occurrences all number	8	14	6
Infections and infestations
URINARY TRACT INFECTION
subjects affected / exposed	6 / 131 (4.58%)	15 / 244 (6.15%)	9 / 113 (7.96%)
occurrences all number	7	21	14
INFUSION SITE INFECTION
subjects affected / exposed	7 / 131 (5.34%)	17 / 244 (6.97%)	10 / 113 (8.85%)
occurrences all number	8	24	16
INFUSION SITE CELLULITIS
subjects affected / exposed	25 / 131 (19.08%)	46 / 244 (18.85%)	21 / 113 (18.58%)
occurrences all number	33	64	31
INFUSION SITE ABSCESS
subjects affected / exposed	9 / 131 (6.87%)	19 / 244 (7.79%)	10 / 113 (8.85%)
occurrences all number	9	21	12

More information

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Were there any global substantial amendments to the protocol? Yes

15 Nov 2018

Version 2.0 -Allowed subjects from Study M15-738 and M15-739 to continue receiving ABBV-951 -Added minimum programmable lockout time of 60 minutes -Changed maximum infusion rate from 1.18 to 1.04 mL/hr -Added "Health-related quality of life as assessed by the EuroQOL 5-dimensions questionnaire (EQ-5D-5L)" as a secondary endpoint -Added A 9-mm Cleo 90 infusion set to Table 8

11 Feb 2019

Version 3.0 -Added Hallucinations/psychosis and somnolence as AESIs -Replace the Minnesota Impulse Disorder Interview (MIDI) with the QUIP-RS -Changed the neurological examination from "symptom-directed" to mandatory and added this to the Week 13 and 39 Visits -Removed assessment of orthostatic vital signs from Visits 6, 7, and 8 (V6, V7, and V8) based on safety data from the Phase 1b study (Study M15-739) -Clarified that during the Monitoring Period (i.e., 6 days before Visit 3 [V3]), subjects should be active (engaged in usual activities of daily living and not sitting or resting on a couch or chair or lying in bed) for at least 30 minutes before taking their first oral dose

28 Aug 2019

Version 4.0 -Removed the allowance of a legally authorized person to provided informed consent for a subject to participate in the study to ensure that appropriate subjects are enrolled -Added eligibility criterion 17 to clarify and exclude medical conditions for which levodopa is contraindicated -Modified eligibility criterion 22 to add that a female subject cannot donate eggs during the study or within 30 days after the end of study drug infusion and to clarify that a female subject does not intend to become pregnant within 30 days after the end of study drug infusion -Modified eligibility criterion 23 to clarify that a male subject does not intend to donate sperm or father a child within 30 days after the end of study drug infusion -Added language to clarify that MAO-A inhibitors are prohibited from 2 weeks prior to the start of levodopa therapy to the end of the Treatment Period -Added zosinamide to the list of allowable concomitant medications during the Treatment Period -Added device causality definitions were added -Incorporated procedures for reporting of events related to the study device -Reduced the duration of the Monitoring Period between Visits 2 and 3 was reduced from 6 to 2 days in situations where the PKG watch is not allowed, per country regulations. A minimum of a 2-day Monitoring Period is required prior to Visit 3 (Day 1) so that PD Diary data are collected. -Increased the frequency of pregnancy testing for women of childbearing potential to every month during the Treatment Period -Modified the instructions on priming of the infusion set -Added language to state that subjects will be instructed on how to return all devices and ancillaries and that study personnel must document compliance -Modified language to indicate that a loading dose is required if drug is suspended for 3 or more hours -Added language to reflect that 2 interim analyses will be performed during the course of the study.

09 Apr 2020

Version 6.0 -Added Neria Guard to the list of study devices -Added a post-treatment follow-up call after Week 52 (V13) to the activity schedule -Removed Unscheduled Visits from the Activity Schedule; added text to protocol to describe unscheduled visits -Removed text related to B12 re-testing outside of the 42-day screening period and clarified the B12 levels that are considered eligible at re-test -Removed text about sites submitting digital images; added that sites will request medical records from the dermatologic visit. Upon receipt of records or reports generated from the dermatologic visit, sites will promptly submit them to AbbVie or designee consistent with typical study data reporting requirements

12 Feb 2021

Version 7.0 -Updated sample size to approximately 240 subjects -Clarified that F3 infusion rate may be reduced beyond the 20% limit from the prescribed base infusion rate (F1) if medically necessary and only with approval from the AbbVie TA MD -Included information on the re-evaluation of the benefit and risk to subjects participating in the study to reflect that there is no additional risk to subjects due to COVID-19 -Modified/added eligibility criteria to minimize additional risk to study subjects or exclude subjects positive for COVID-19 -Clarified that protocol deviations may include modifications due to COVID-19 -Added instructions for COVID-19 pandemic-related acceptable protocol modifications and to refer to the Operations Manual for details on how to handle necessary changes to activities or procedures -Noted that AbbVie will modify the study protocol as necessary due to the COVID-19 pandemic. Investigators must also notify AbbVie if any urgent safety measures are taken -Noted that remote monitoring during the COVID-19 pandemic may be employed as needed -Updated Operations Manual to include details on how to perform specific activities/procedures that may be impacted by changes in global/local regulations due to the COVID-19 pandemic -Added additional details regarding ABBV-951 and infusion site reactions -Added hallucinations/psychosis as a common symptom in patients with PD and included general guidance -Added text to clarify that the appropriate cannula length will be selected by the investigator based on individual subject characteristics (thickness of the abdominal subcutaneous fat tissue) and noted that the investigator should consider instructing the subject to rotate the infusion site more frequently -Added alternative infusion site locations and considerations guidance -Removed references to "caregivers" throughout protocol and Operations Manual -Changed the reporting timeframe for product complaints to 24 hours

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A 52-Week, Open-Label, Single-Arm Study to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects with Parkinson's Disease

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Adverse Events

Primary: Number of Participants With Adverse Events

Primary: Number of Participants With Adverse Events of Special Interest

Primary: Number of Participants With Adverse Events of Special Interest

Primary: Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale

Primary: Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale

Primary: Hematocrit (Hematology): Change From Baseline to End of Study

Primary: Hematocrit (Hematology): Change From Baseline to End of Study

Primary: Hemoglobin (Hematology): Change From Baseline to End of Study

Primary: Hemoglobin (Hematology): Change From Baseline to End of Study

Primary: Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study

Primary: Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study

Primary: White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study

Primary: White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study

Primary: Neutrophils (Hematology): Change From Baseline to End of Study

Primary: Neutrophils (Hematology): Change From Baseline to End of Study

Primary: Lymphocytes (Hematology): Change From Baseline to End of Study

Primary: Lymphocytes (Hematology): Change From Baseline to End of Study

Primary: Monocytes (Hematology): Change From Baseline to End of Study

Primary: Monocytes (Hematology): Change From Baseline to End of Study

Primary: Absolute Platelet Count (Hematology): Change From Baseline to End of Study

Primary: Absolute Platelet Count (Hematology): Change From Baseline to End of Study

Primary: Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study

Primary: Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study

Primary: Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study

Primary: Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study

Primary: Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study

Primary: Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study

Primary: Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study

Primary: Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study

Primary: Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study

Primary: Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatinine (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatinine (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study

Primary: Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study

Primary: Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study

Primary: Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study

Primary: Sodium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Sodium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Potassium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Potassium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Calcium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Calcium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study

Primary: Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study

Primary: Uric Acid (Clinical Chemistry): Change From Baseline to End of Study

Primary: Uric Acid (Clinical Chemistry): Change From Baseline to End of Study

Primary: Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study

Primary: Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study

Primary: Albumin (Clinical Chemistry): Change From Baseline to End of Study

Primary: Albumin (Clinical Chemistry): Change From Baseline to End of Study

Primary: Glucose (Clinical Chemistry): Change From Baseline to End of Study

Primary: Glucose (Clinical Chemistry): Change From Baseline to End of Study

Primary: Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study

Primary: Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study

Primary: Magnesium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Magnesium (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study

Primary: Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study

Clinical Trial Results:
A 52-Week, Open-Label, Single-Arm Study to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects with Parkinson's Disease