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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Plaque Psoriasis

Summary
EudraCT number	2013-000537-12
Trial protocol	HU DE PL FR
Global end of trial date	18 Mar 2015

Results information
Results version number	v1(current)
This version publication date	01 Apr 2016
First version publication date	01 Apr 2016
Other versions

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

20120263

ISRCTN number

US NCT number

NCT01970488

WHO universal trial number (UTN)

Sponsor organisation name

Amgen, Inc.

Sponsor organisation address

One Amgen Center Drive, Thousand Oaks, CA, United States, 91320

Public contact

IHQ Medical Info-Clinical Trials, Amgen (Europe) GmbH, Medinfointernational@amgen.com

Scientific contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, Medinfointernational@amgen.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

18 Mar 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

18 Mar 2015

Was the trial ended prematurely?

Main objective of the trial

The primary objective for this study was to evaluate the efficacy of ABP 501 in subjects with moderate to severe plaque psoriasis, as measured by the percent improvement from baseline in the Psoriasis Area and Severity Index (PASI), compared with adalimumab.

Protection of trial subjects

This study was conducted in accordance with the Note for Guidance on GCP, the general guidelines indicated in the Declaration of Helsinki and all applicable regulatory requirements. Before initiating the study, the investigator/institution obtained written and dated approval/favorable opinion from the IRB/IEC for the study protocol, amendments, and the informed consent form (ICF). The investigator explained the benefits and risks of study participation to each subject or the subject’s legal representative. Written informed consent was obtained before the subject entered the study and before initiation of any study-related procedure.

Background therapy

Evidence for comparator

Actual start date of recruitment

18 Oct 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 100

Country: Number of subjects enrolled

France: 6

Country: Number of subjects enrolled

Germany: 80

Country: Number of subjects enrolled

Hungary: 41

Country: Number of subjects enrolled

Canada: 89

Country: Number of subjects enrolled

Australia: 34

Worldwide total number of subjects

350

EEA total number of subjects

227

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)

327

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

After a 4-week screening period, subjects were randomized (1:1) to ABP 501 or adalimumab. Randomization was stratified based on prior biologic use for psoriasis and geographic region. At week 16, participants with a PASI50 response (50% or greater improvement from baseline in PASI score) were re-randomized to receive either ABP 501 or adalimumab.

Period 1 title

Part 1: Through Week 16

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Part 1: ABP 501

Arm description

Participants received ABP 501 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Arm type

Experimental

Investigational medicinal product name

ABP 501

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Initial loading dose of 80 mg administered by subcutaneous injection on Week 1/Day 1 and 40 mg at Week 2 and every 2 weeks thereafter.

Part 1: Adalimumab

Arm description

Participants received adalimumab 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Humira

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Initial loading dose of 80 mg administered by subcutaneous injection on Week 1/Day 1 and 40 mg at Week 2 and every 2 weeks thereafter.

Number of subjects in period 1	Part 1: ABP 501	Part 1: Adalimumab
Started	175	175
Received Treatment	174	173
Completed	164	162
Not completed	11	13
Consent withdrawn by subject	3	2
Adverse event, non-fatal	6	5
Protocol violations	1	2
Lost to follow-up	-	2
Protocol-specified criteria	1	2

Period 2 title

Part 2: Post Week 16

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Subjects who continued treatment beyond week 16 were re-randomized in a blinded fashion such that all subjects initially randomized to ABP 501 continued treatment with ABP 501 and subjects initially randomized to adalimumab were re-randomized (1:1) in a blinded fashion to continue treatment with adalimumab or transition to ABP 501.

Are arms mutually exclusive

Yes

Part 2: ABP 501/ABP 501

Arm description

Participants who received ABP 501 in Part 1 with a PASI50 response at Week 16 continued to receive ABP 501, 40 mg every 2 weeks until Week 48.

Arm type

Experimental

Investigational medicinal product name

ABP 501

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

40 mg administered by subcutaneous injection every 2 weeks.

Part 2: Adalimumab/Adalimumab

Arm description

Participants who received adalimumab in Part 1 with a PASI50 response at Week 16 continued to receive adalimumab, 40 mg every 2 weeks until Week 48.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Humira

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

40 mg administered by subcutaneous injection every 2 weeks.

Part 2: Adalimumab/ABP 501

Arm description

Participants who received adalimumab in Part 1 with a PASI50 response at Week 16 were transitioned to receive ABP 501, 40 mg every 2 weeks until Week 48.

Arm type

Experimental

Investigational medicinal product name

ABP 501

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

40 mg administered by subcutaneous injection every 2 weeks.

Number of subjects in period 2 ^[1]	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Started	152	79	77
Completed	135	71	69
Not completed	17	8	8
Consent withdrawn by subject	8	3	3
Physician decision	-	-	1
Adverse event, non-fatal	5	1	1
Non-compliance	1	-	-
Lost to follow-up	1	1	2
Lack of efficacy	2	3	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Only participants with a PASI50 response continued into Part 2 of the study.

Baseline characteristics

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Reporting group title

Part 1: ABP 501

Reporting group description

Participants received ABP 501 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group title

Part 1: Adalimumab

Reporting group description

Participants received adalimumab 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group values	Part 1: ABP 501	Part 1: Adalimumab	Total
Number of subjects	175	175	350
Age categorical
Units: Subjects
< 65 years	164	163	327
≥ 65 years	11	12	23
Age continuous
Units: years
arithmetic mean (standard deviation)	45.1 ± 12.95	44 ± 13.68	-
Gender categorical
Units: Subjects
Female	63	59	122
Male	112	116	228
Race
Units: Subjects
White	167	157	324
Black or African American	0	2	2
Asian	5	8	13
Native Hawaiian or Other Pacific Islander	0	1	1
Mixed Race	0	1	1
Other	1	3	4
Unknown	2	3	5
Prior Biological Use for Psoriasis
Units: Subjects
Yes	33	30	63
No	142	145	287
Region
Units: Subjects
Eastern Europe	71	70	141
Western Europe	43	43	86
Other	61	62	123
Static Physician’s Global Assessment (sPGA)
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).
Units: Subjects
Clear	0	0	0
Almost Clear	0	0	0
Mild	0	0	0
Mderate	106	102	208
Severe	61	61	122
Very Severe	7	10	17
Missing	1	2	3
Psoriasis Area and Severity Index (PASI) Score
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Data are reported for 174 and 173 participants in each reporting group respectively.
Units: units on a scale
arithmetic mean (standard deviation)	19.68 ± 8.1	20.48 ± 7.88	-
Body Surface Area (BSA) Affected by Psoriasis
Data are reported for 174 and 173 participants in each treatment group respectively.
Units: percentage of BSA
arithmetic mean (standard deviation)	25.3 ± 15.02	28.5 ± 16.82	-

End points

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Reporting group title

Part 1: ABP 501

Reporting group description

Participants received ABP 501 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group title

Part 1: Adalimumab

Reporting group description

Participants received adalimumab 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group title

Part 2: ABP 501/ABP 501

Reporting group description

Participants who received ABP 501 in Part 1 with a PASI50 response at Week 16 continued to receive ABP 501, 40 mg every 2 weeks until Week 48.

Reporting group title

Part 2: Adalimumab/Adalimumab

Reporting group description

Participants who received adalimumab in Part 1 with a PASI50 response at Week 16 continued to receive adalimumab, 40 mg every 2 weeks until Week 48.

Reporting group title

Part 2: Adalimumab/ABP 501

Reporting group description

Participants who received adalimumab in Part 1 with a PASI50 response at Week 16 were transitioned to receive ABP 501, 40 mg every 2 weeks until Week 48.

Primary: Percent Improvement from Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

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End point title

Percent Improvement from Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

End point description

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) X 100 / (value at baseline). This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used.

End point type

Primary

End point timeframe

Baseline and Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[1]	173 ^[2]
Units: percent change
arithmetic mean (standard deviation)	80.91 ± 24.237	83.06 ± 25.195

Notes
[1] - Full analysis set with at least 1 post-baseline value
[2] - Full analysis set with at least 1 post-baseline value

Treatment Difference

Comparison groups

Part 1: ABP 501 v Part 1: Adalimumab

Number of subjects included in analysis

345

Analysis specification

Pre-specified

Analysis type

equivalence ^[3]

Method

Parameter type

Least-squares (LS) mean difference

Point estimate

-2.18

Confidence interval

level

95%

sides

2-sided

lower limit

-7.39

upper limit

3.02

Notes
[3] - Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.

Secondary: Percentage of Participants With a PASI 75 Response at Week 16

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End point title

Percentage of Participants With a PASI 75 Response at Week 16

End point description

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. This analysis was performed in the full analysis set using LOCF.

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[4]	173 ^[5]
Units: percentage of participants
number (not applicable)	74.4	82.7

Notes
[4] - Full analysis set with at least 1 post-baseline value
[5] - Full analysis set with at least 1 post-baseline value

No statistical analyses for this end point

Secondary: Percentage of Participants With a PASI 75 Response at Week 32

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End point title

Percentage of Participants With a PASI 75 Response at Week 32

End point description

End point type

Secondary

End point timeframe

Baseline and Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[6]	72 ^[7]	71 ^[8]
Units: percentage of participants
number (not applicable)	82.5	84.7	84.5

Notes
[6] - Re-randomized analysis set with available data
[7] - Re-randomized analysis set with available data
[8] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Percentage of Participants With a PASI 75 Response at Week 50

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End point title

Percentage of Participants With a PASI 75 Response at Week 50

End point description

End point type

Secondary

End point timeframe

Baseline and Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[9]	70 ^[10]	69 ^[11]
Units: percentage of participants
number (not applicable)	85.1	87.1	81.2

Notes
[9] - Re-randomized analysis set with available data
[10] - Re-randomized analysis set with available data
[11] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Percent Improvement From Baseline in PASI at Week 32

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End point title

Percent Improvement From Baseline in PASI at Week 32

End point description

End point type

Secondary

End point timeframe

Baseline and Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[12]	72 ^[13]	71 ^[14]
Units: percent change
arithmetic mean (standard deviation)	87.62 ± 18.387	88.16 ± 18.181	86.98 ± 16.637

Notes
[12] - Re-randomized analysis set with available data
[13] - Re-randomized analysis set with available data
[14] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Percent Improvement From Baseline in PASI at Week 50

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End point title

Percent Improvement From Baseline in PASI at Week 50

End point description

End point type

Secondary

End point timeframe

Baseline and Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[15]	70 ^[16]	69 ^[17]
Units: percent change
arithmetic mean (standard deviation)	87.16 ± 19.559	88.11 ± 20.957	85.82 ± 21.864

Notes
[15] - Re-randomized analysis set with available data
[16] - Re-randomized analysis set with available data
[17] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Percentage of Participants with a Static Physician’s Global Assessment (sPGA) Response at Week 16

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End point title

Percentage of Participants with a Static Physician’s Global Assessment (sPGA) Response at Week 16

End point description

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1). This analysis was performed using the full analysis set; LOCF imputation was used.

End point type

Secondary

End point timeframe

Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[18]	173 ^[19]
Units: percentage of participants
number (not applicable)	58.7	65.3

Notes
[18] - Full analysis set with at least 1 post-baseline value
[19] - Full analysis set with at least 1 post-baseline value

No statistical analyses for this end point

Secondary: Percentage of Participants with a sPGA Response at Week 32

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End point title

Percentage of Participants with a sPGA Response at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[20]	72 ^[21]	71 ^[22]
Units: percentage of participants
number (not applicable)	66.4	72.2	70.4

Notes
[20] - Re-randomized analysis set with available data
[21] - Re-randomized analysis set with available data
[22] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Percentage of Participants with a sPGA Response at Week 50

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End point title

Percentage of Participants with a sPGA Response at Week 50

End point description

End point type

Secondary

End point timeframe

Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[23]	70 ^[24]	69 ^[25]
Units: percentage of participants
number (not applicable)	68.7	74.3	69.6

Notes
[23] - Re-randomized analysis set with available data
[24] - Re-randomized analysis set with available data
[25] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16

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End point title

Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16

End point description

A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. A decrease from Baseline (negative value) indicates improvement. This analysis was performed in the full analysis set; LOCF imputation was used.

End point type

Secondary

End point timeframe

Baseline and Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[26]	173 ^[27]
Units: Percentage of BSA
arithmetic mean (standard deviation)	-18 ± 13.57	-22.1 ± 17.11

Notes
[26] - Full analysis set with at least 1 post-baseline value
[27] - Full analysis set with at least 1 post-baseline value

No statistical analyses for this end point

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32

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End point title

Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32

End point description

End point type

Secondary

End point timeframe

Baseline and Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[28]	72 ^[29]	71 ^[30]
Units: percentage of BSA
arithmetic mean (standard deviation)	-20.6 ± 13.87	-25.3 ± 15.94	-23.8 ± 16.17

Notes
[28] - Re-randomized analysis set with available data
[29] - Re-randomized analysis set with available data
[30] - Re-randomized analysis set with available data

No statistical analyses for this end point

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50

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End point title

Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50

End point description

End point type

Secondary

End point timeframe

Baseline and Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[31]	70 ^[32]	69 ^[33]
Units: percentage of BSA
arithmetic mean (standard deviation)	-20.7 ± 13.58	-25.5 ± 16.14	-25.1 ± 17.43

Notes
[31] - Re-randomized anlaysis set with available data
[32] - Re-randomized anlaysis set with available data
[33] - Re-randomized anlaysis set with available data

No statistical analyses for this end point

Secondary: Number of Participants with Adverse Events

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End point title

Number of Participants with Adverse Events

End point description

The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product (TRAE). AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. A serious AE is defined as an AE that meets at least 1 of the following serious criteria: - fatal - life threatening (places the subject at immediate risk of death) - requires inpatient hospitalization or prolongation of existing hospitalization - results in persistent or significant disability/incapacity - congenital anomaly/birth defect - other medically important serious event. Results are reported from Day 1 to Week 16 for the ABP 501 and Adalimumab groups, and from post Week 16 to the end of study (Week 52) for the ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups. The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.

End point type

Secondary

End point timeframe

From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.

End point values	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	174 ^[34]	173 ^[35]	152 ^[36]	79 ^[37]	77 ^[38]
Units: participants
Any adverse event	117	110	108	52	54
Grade ≥ 3 adverse event	8	5	7	2	3
Treatment-related adverse event	43	43	28	18	20
Grade ≥ 3 treatment-related adverse event	4	2	3	1	1
Serious adverse event	6	5	4	4	4
Treatment-related serious adverse event	4	0	2	1	1
AE leading to discontinuation of study drug	7	5	7	1	3
TRAE leading to discontinuation of study drug	4	3	3	1	2
AE leading to discontinuation from study	7	5	4	1	2
TRAE leading to discontinuation from study	4	3	2	1	1

Notes
[34] - Safety analysis set
[35] - Safety analysis set
[36] - Safety analysis set
[37] - Safety analysis set
[38] - Safety analysis set

No statistical analyses for this end point

Secondary: Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab

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End point title

Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab

End point description

Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay). Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point. Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.

End point type

Secondary

End point timeframe

For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.

End point values	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	174 ^[39]	173 ^[40]	152 ^[41]	79 ^[42]	77 ^[43]
Units: percentage of participants
number (not applicable)
Binding Antibody Positive	55.2	63.6	68.4	74.7	72.7
Neutralizing Antibody Positive	9.8	13.9	13.8	20.3	24.7

Notes
[39] - Anti-drug antibody analysis set
[40] - Anti-drug antibody analysis set
[41] - Anti-drug antibody analysis set; re-randomized participants
[42] - Anti-drug antibody analysis set; re-randomized participants
[43] - Anti-drug antibody analysis set; re-randomized participants

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 16

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End point title

Percentage of Participants With a PASI 90 Response at Week 16

End point description

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. This analysis was performed in the full analysis set using LOCF imputation.

End point type

Post-hoc

End point timeframe

Baseline and Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[44]	173 ^[45]
Units: percentage of participants
number (not applicable)	47.1	47.4

Notes
[44] - Full analysis set with at least 1 post-baseline value
[45] - Full analysis set with at least 1 post-baseline value

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 32

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End point title

Percentage of Participants With a PASI 90 Response at Week 32

End point description

End point type

Post-hoc

End point timeframe

Baseline and Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[46]	72 ^[47]	71 ^[48]
Units: percentage of participants
number (not applicable)	62.2	65.3	57.7

Notes
[46] - Re-randomized analysis set with available data
[47] - Re-randomized analysis set with available data
[48] - Re-randomized analysis set with available data

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 50

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End point title

Percentage of Participants With a PASI 90 Response at Week 50

End point description

End point type

Post-hoc

End point timeframe

Baseline and Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[49]	70 ^[50]	69 ^[51]
Units: percentage of participants
number (not applicable)	59	64.3	66.7

Notes
[49] - Re-randomized analysis set with available data
[50] - Re-randomized analysis set with available data
[51] - Re-randomized analysis set with available data

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 16

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End point title

Percentage of Participants With a PASI 100 Response at Week 16

End point description

A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. This analysis was performed in the full analysis set using LOCF imputation.

End point type

Post-hoc

End point timeframe

Baseline and Week 16

End point values	Part 1: ABP 501	Part 1: Adalimumab
Number of subjects analysed	172 ^[52]	173 ^[53]
Units: percentage of participants
number (not applicable)	16.9	19.7

Notes
[52] - Full analysis set with at least 1 post-baseline value
[53] - Full analysis set with at least 1 post-baseline value

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 32

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End point title

Percentage of Participants With a PASI 100 Response at Week 32

End point description

End point type

Post-hoc

End point timeframe

Baseline and Week 32

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	143 ^[54]	72 ^[55]	71 ^[56]
Units: percentage of participants
number (not applicable)	32.9	33.3	25.4

Notes
[54] - Re-randomized analysis set with available data
[55] - Re-randomized analysis set with available data
[56] - Re-randomized analysis set with available data

No statistical analyses for this end point

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 50

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End point title

Percentage of Participants With a PASI 100 Response at Week 50

End point description

End point type

Post-hoc

End point timeframe

Baseline and Week 50

End point values	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Number of subjects analysed	134 ^[57]	70 ^[58]	69 ^[59]
Units: percentage of participants
number (not applicable)	32.8	35.7	34.8

Notes
[57] - Re-randomized analysis set with available data
[58] - Re-randomized analysis set with available data
[59] - Re-randomized analysis set with available data

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Part 1: ABP 501

Reporting group description

In Part 1 (Weeks 1-16) participants received ABP 501 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group title

Part 1: Adalimumab

Reporting group description

In Part 1 (Weeks 1-16) participants received adalimumab 80 mg subcutaneously on Week 1/Day 1 (initial loading dose) and 40 mg at Week 2 and every 2 weeks thereafter until Week 16.

Reporting group title

Part 2: ABP 501/ABP 501

Reporting group description

In Part 2 participants who received ABP 501 in Part 1 with a PASI50 response at Week 16 continued to receive ABP 501, 40 mg every 2 weeks until Week 48.

Reporting group title

Part 2: Adalimumab/Adalimumab

Reporting group description

In Part 2 participants who received adalimumab in Part 1 with a PASI50 response at Week 16 continued to receive adalimumab, 40 mg every 2 weeks until Week 48.

Reporting group title

Part 2: Adalimumab/ABP 501

Reporting group description

In Part 2 participants who received adalimumab in Part 1 with a PASI50 response at Week 16 were transitioned to receive ABP 501, 40 mg every 2 weeks until Week 48.

Serious adverse events	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 174 (3.45%)	5 / 173 (2.89%)	4 / 152 (2.63%)	4 / 79 (5.06%)	4 / 77 (5.19%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral ischaemia
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	1 / 79 (1.27%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	1 / 79 (1.27%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 174 (0.00%)	1 / 173 (0.58%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	1 / 77 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Metrorrhagia
subjects affected / exposed	0 / 174 (0.00%)	1 / 173 (0.58%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	1 / 77 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Drug-induced liver injury
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	1 / 79 (1.27%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	1 / 79 (1.27%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 174 (0.00%)	1 / 173 (0.58%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Patellofemoral pain syndrome
subjects affected / exposed	0 / 174 (0.00%)	1 / 173 (0.58%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 174 (0.00%)	1 / 173 (0.58%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	1 / 77 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 174 (0.57%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	0 / 152 (0.00%)	0 / 79 (0.00%)	1 / 77 (1.30%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dyslipidaemia
subjects affected / exposed	0 / 174 (0.00%)	0 / 173 (0.00%)	1 / 152 (0.66%)	0 / 79 (0.00%)	0 / 77 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Part 1: ABP 501	Part 1: Adalimumab	Part 2: ABP 501/ABP 501	Part 2: Adalimumab/Adalimumab	Part 2: Adalimumab/ABP 501
Total subjects affected by non serious adverse events
subjects affected / exposed	50 / 174 (28.74%)	60 / 173 (34.68%)	48 / 152 (31.58%)	31 / 79 (39.24%)	34 / 77 (44.16%)
Nervous system disorders
Headache
subjects affected / exposed	12 / 174 (6.90%)	18 / 173 (10.40%)	5 / 152 (3.29%)	8 / 79 (10.13%)	2 / 77 (2.60%)
occurrences all number	13	22	9	10	11
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 174 (1.15%)	3 / 173 (1.73%)	3 / 152 (1.97%)	4 / 79 (5.06%)	8 / 77 (10.39%)
occurrences all number	2	3	3	4	8
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	2 / 174 (1.15%)	2 / 173 (1.16%)	10 / 152 (6.58%)	5 / 79 (6.33%)	4 / 77 (5.19%)
occurrences all number	2	2	12	6	4
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	5 / 174 (2.87%)	7 / 173 (4.05%)	4 / 152 (2.63%)	5 / 79 (6.33%)	2 / 77 (2.60%)
occurrences all number	5	10	5	5	2
Back pain
subjects affected / exposed	7 / 174 (4.02%)	1 / 173 (0.58%)	5 / 152 (3.29%)	5 / 79 (6.33%)	1 / 77 (1.30%)
occurrences all number	7	1	6	5	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	25 / 174 (14.37%)	27 / 173 (15.61%)	25 / 152 (16.45%)	14 / 79 (17.72%)	18 / 77 (23.38%)
occurrences all number	30	29	30	18	22
Upper respiratory tract infection
subjects affected / exposed	9 / 174 (5.17%)	9 / 173 (5.20%)	9 / 152 (5.92%)	6 / 79 (7.59%)	7 / 77 (9.09%)
occurrences all number	9	10	10	6	11

More information

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Were there any global substantial amendments to the protocol? Yes

03 Dec 2013

The following are the substantive changes covered by this amendment: - deleted PASI percent change as a secondary efficacy parameter - narrowed the equivalence margin used to assess clinical equivalence of PASI percent improvement to ± 15 - added additional efficacy assessments at the week 32 visit - clarified specific entry criteria - no evidence of active tuberculosis on chest radiograph was allowed within 3 months before screening - the presence or absence of active substance abuse was based on the investigator’s opinion - contraception was required until 5 months after the last dose of study medication (not the end of study) - clarified that change in vital signs from baseline was a safety assessment rather than clinically significant changes in vital signs - specified that the primary analysis would be based on randomized treatment assignment - reduced the allowable window for day 8 treatment to days 8 to 11 after the first dose of investigational product and specified that no fewer than 7 days must elapse between any 2 doses of study medication - modified the prohibited concomitant medications to allow, if needed, live attenuated vaccines after the week 16 visit provided there was a treatment interruption of at least 28 days before and after vaccination - defined the determination of BSA as based on measurement of the subject’s palm, excluding fingers and thumb - specified that the primary analysis would occur after all subjects completed week 20 - deleted the planned interim analysis - clarified that concomitant were to be reported from 4 weeks before screening

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 Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percent Improvement from Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

Primary: Percent Improvement from Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

Secondary: Percentage of Participants With a PASI 75 Response at Week 16

Secondary: Percentage of Participants With a PASI 75 Response at Week 16

Secondary: Percentage of Participants With a PASI 75 Response at Week 32

Secondary: Percentage of Participants With a PASI 75 Response at Week 32

Secondary: Percentage of Participants With a PASI 75 Response at Week 50

Secondary: Percentage of Participants With a PASI 75 Response at Week 50

Secondary: Percent Improvement From Baseline in PASI at Week 32

Secondary: Percent Improvement From Baseline in PASI at Week 32

Secondary: Percent Improvement From Baseline in PASI at Week 50

Secondary: Percent Improvement From Baseline in PASI at Week 50

Secondary: Percentage of Participants with a Static Physician’s Global Assessment (sPGA) Response at Week 16

Secondary: Percentage of Participants with a Static Physician’s Global Assessment (sPGA) Response at Week 16

Secondary: Percentage of Participants with a sPGA Response at Week 32

Secondary: Percentage of Participants with a sPGA Response at Week 32

Secondary: Percentage of Participants with a sPGA Response at Week 50

Secondary: Percentage of Participants with a sPGA Response at Week 50

Secondary: Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16

Secondary: Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50

Secondary: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50

Secondary: Number of Participants with Adverse Events

Secondary: Number of Participants with Adverse Events

Secondary: Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab

Secondary: Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 16

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 16

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 32

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 32

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 50

Post-hoc: Percentage of Participants With a PASI 90 Response at Week 50

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 16

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 16

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 32

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 32

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 50

Post-hoc: Percentage of Participants With a PASI 100 Response at Week 50

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Plaque Psoriasis