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Clinical Trial Results:
BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis

Summary
EudraCT number	2014-005117-23
Trial protocol	DE CZ
Global end of trial date	18 Sep 2017

Results information
Results version number	v2(current)
This version publication date	17 Jul 2019
First version publication date	21 Sep 2018
Other versions	v1
Version creation reason

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

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Trial information

Top of page

Sponsor protocol code

1311.3

ISRCTN number

US NCT number

NCT02684370

WHO universal trial number (UTN)

Sponsor organisation name

Boehringer Ingelheim

Sponsor organisation address

Binger Strasse 173, Ingelheim am Rhein, Germany, 55216

Public contact

QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 800 243 0127, clintriage.rdg@boehringer-ingelheim.com

Scientific contact

QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 800 243 0127, clintriage.rdg@boehringer-ingelheim.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 Oct 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Dec 2016

Global end of trial reached?

Yes

Global end of trial date

18 Sep 2017

Was the trial ended prematurely?

Main objective of the trial

The main objectives of this study were to assess the efficacy and safety of risankizumab, compared to ustekinumab and placebo, in subjects with moderate to severe chronic plaque psoriasis. In addition, this study was to assess pharmacokinetics (PK) and the emergence of anti-drug antibodies and their effect on efficacy and safety.

Protection of trial subjects

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were informed that they were free to withdraw their consent at any time during the study without penalty or prejudice. The subjects were informed that their personal trial related data would be considered confidential and used by BI in accordance with the local data protection laws. The level of disclosure was explained to the subjects. The subjects were also informed that their medical records could be examined by Clinical Quality Assurance auditors appointed by BI, by members of the appropriate Independent Ethics Committee (IEC), and by inspectors from regulatory authorities. Confidentiality of subject data was ensured by the use of depersonalised subject identification codes (subject numbers). If a subject continued to take trial medication, close monitoring was adhered to and all adverse events recorded. The terms and conditions of the insurance cover were available to the investigator and the subjects in the Investigator Site File (ISF).

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Feb 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 46

Country: Number of subjects enrolled

Canada: 108

Country: Number of subjects enrolled

Czech Republic: 12

Country: Number of subjects enrolled

France: 17

Country: Number of subjects enrolled

Germany: 42

Country: Number of subjects enrolled

Japan: 51

Country: Number of subjects enrolled

Korea, Republic of: 52

Country: Number of subjects enrolled

United States: 232

Worldwide total number of subjects

560

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)

492

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Participants were randomized to placebo, ustekinumab or risankizumab in Part A. Participants who received placebo in Part A switched to risankizumab in Part B participants who received ustekinumab and risankizumab in Part A continued the same in Part B. Total 560 subjects were enrolled 54 subjects failed screening and are excluded from the analyses

Period 1 title

Part A

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab.

Are arms mutually exclusive

Yes

Placebo (Part A)

Arm description

Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo were administered by subcutaneous (SC) injection at Weeks 0 and 4

Ustekinumab (Part A)

Arm description

Participants randomized to receive double-blind (DB) ustekinumab 45 milligram (mg) or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind ( ustekinumab and placebo for risankizumab)

Arm type

Active comparator

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Ustekinumab 45 mg or 90 mg were administered by subcutaneous (SC) injection at Weeks 0 and 4

Investigational medicinal product name

Placebo for Risankizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized to receive Placebo for Risankizumab subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Risankizumab (Part A)

Arm description

Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). They received 2 sets of injections to maintain the blind (risankizumab and placebo for ustekinumab)

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Risankizumab 150 mg were administered by subcutaneous (SC) injection at Weeks 0 and 4

Investigational medicinal product name

Placebo for Ustekinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized to receive Placebo for Ustekinumab subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Number of subjects in period 1 ^[1]	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)
Started	102	100	304
Completed	98	99	299
Not completed	4	1	5
Adverse event, non-fatal	2	-	1
Not specified	-	-	1
Lost to follow-up	1	1	-
Withdrawal by subject	1	-	3

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Baseline characteristics are based on the patients who were randomised at week 0 after successfully completing the screening period

Period 2 title

Part B

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

Are arms mutually exclusive

Yes

Placebo/Risankizumab (Part B)

Arm description

Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40.

Ustekinumab/Ustekinumab (Part B)

Arm description

Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Arm type

Experimental

Investigational medicinal product name

Ustekinumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28 and 40.

Risankizumab/Risankizumab (Part B)

Arm description

Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40.

Number of subjects in period 2 ^[2]	Placebo/Risankizumab (Part B)	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Started	97	99	297
Completed	95	94	289
Not completed	2	5	8
Adverse event, non-fatal	-	2	1
Subject Withdrawal	1	1	2
Lost to follow-up	1	2	5

Notes
[2] - 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: The number of subjects starting the period 1 (Part A) have switched their treatments in period 2 (Part B).

Baseline characteristics

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Reporting group title

Placebo (Part A)

Reporting group description

Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Reporting group title

Ustekinumab (Part A)

Reporting group description

Reporting group title

Risankizumab (Part A)

Reporting group description

Reporting group values	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)	Total
Number of subjects	102	100	304	506
Age categorical
Units: Subjects
Age Continuous
Age of all patients included in the study. Intent-to-treat (ITT) population: All participants who were randomized at Week 0.
Units: years
arithmetic mean (standard deviation)	49.3 ± 13.63	46.5 ± 13.42	48.3 ± 13.39	-
Sex: Female, Male
Gender distribution of all patients included in the study. ITT population was used for this assessment.
Units: Subjects
Female	23	30	92	145
Male	79	70	212	361
Ethnicity (NIH/OMB)
Ethnicity of all patients included in the study. ITT population was used for this assessment.
Units: Subjects
Hispanic or Latino	12	12	23	47
Not Hispanic or Latino	90	88	281	459
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB)
Race of all patients included in the study. ITT population was used for this assessment.
Units: Subjects
American Indian or Alaska Native	2	2	7	11
Asian	28	22	86	136
Native Hawaiian or Other Pacific Islander	0	1	1	2
Black or African American	1	1	10	12
White	71	74	200	345
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

End points

Top of page

Reporting group title

Placebo (Part A)

Reporting group description

Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Reporting group title

Ustekinumab (Part A)

Reporting group description

Reporting group title

Risankizumab (Part A)

Reporting group description

Reporting group title

Placebo/Risankizumab (Part B)

Reporting group description

Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Reporting group title

Ustekinumab/Ustekinumab (Part B)

Reporting group description

Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Reporting group title

Risankizumab/Risankizumab (Part B)

Reporting group description

Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Subject analysis set title

Ustekinumab/Ustekinumab (Part B)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Subject analysis set title

Risankizumab/Risankizumab (Part B)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A). ^[1]

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data. ITT population (Intent-to-treat (ITT): All participants who were randomized at Week 0) was used for this assessment.

End point type

Primary

End point timeframe

Baseline and Week 16

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[2]	304 ^[3]
Units: percentage of participants
number (not applicable)	4.9	75.3

Notes
[2] - ITT
[3] - ITT

Statistical analysis 1

Statistical analysis description

Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kilo gram (kg) versus (vs) >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

70.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

76.7

Notes
[4] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

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End point title

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A). ^[5]

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. ITT population was used for this assessment.

End point type

Primary

End point timeframe

Week 16

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[6]	304 ^[7]
Units: percentage of participants
number (not applicable)	7.8	87.8

Notes
[6] - ITT
[7] - ITT

Statistical analysis 1

Statistical analysis description

Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

other ^[8]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

79.9

Confidence interval

level

95%

sides

2-sided

lower limit

73.5

upper limit

86.3

Notes
[8] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A). ^[9]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[10]	304 ^[11]
Units: percentage of participants
number (not applicable)	2.0	36.8

Notes
[10] - ITT
[11] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

other ^[12]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

34.7

Confidence interval

level

95%

sides

2-sided

lower limit

28.6

upper limit

40.8

Notes
[12] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

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End point title

Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) ^[13]

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. ITT population was used for this assessment.

End point type

Secondary

End point timeframe

Week 16

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[14]	304 ^[15]
Units: percentage of participants
number (not applicable)	0.0	35.9

Notes
[14] - ITT
[15] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

^[16]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

35.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Notes
[16] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

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End point title

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) ^[17]

End point description

DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient’s life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient’s life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data. ITT population was used for this assessment.

End point type

Secondary

End point timeframe

Week 16

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[18]	304 ^[19]
Units: percentage of participants
number (not applicable)	7.8	65.8

Notes
[18] - ITT
[19] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

other ^[20]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

57.9

Confidence interval

level

95%

sides

2-sided

lower limit

50.4

upper limit

65.3

Notes
[20] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

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End point title

Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) ^[21]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	102 ^[22]	304 ^[23]
Units: percentage of participants
number (not applicable)	2.0	29.3

Notes
[22] - ITT
[23] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

406

Analysis specification

Pre-specified

Analysis type

other ^[24]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

27.1

Confidence interval

level

95%

sides

2-sided

lower limit

21.2

upper limit

32.9

Notes
[24] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in placebo group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Top of page

End point title

Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[25]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[26]	304 ^[27]
Units: percentage of participants
number (not applicable)	42.0	75.3

Notes
[26] - ITT
[27] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[28]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

33.5

Confidence interval

level

95%

sides

2-sided

lower limit

22.7

upper limit

44.3

Notes
[28] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

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End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[29]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[30]	304 ^[31]
Units: percentage of participants
number (not applicable)	63.0	87.8

Notes
[30] - ITT
[31] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[32]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

25.1

Confidence interval

level

95%

sides

2-sided

lower limit

15.2

upper limit

Notes
[32] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

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End point title

Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[33]

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. ITT population was used for this assessment.

End point type

Secondary

End point timeframe

Week 16

Notes
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[34]	304 ^[35]
Units: percentage of participants
number (not applicable)	12.0	35.9

Notes
[34] - ITT
[35] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[36]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

23.8

Confidence interval

level

95%

sides

2-sided

lower limit

15.5

upper limit

32.1

Notes
[36] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[37]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[38]	304 ^[39]
Units: percentage of participants
number (not applicable)	14.0	36.8

Notes
[38] - ITT
[39] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[40]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

22.9

Confidence interval

level

95%

sides

2-sided

lower limit

14.3

upper limit

31.6

Notes
[40] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

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End point title

Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data. ITT population was used for this assessment. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.

End point type

Secondary

End point timeframe

Week 52

End point values	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Number of subjects analysed	100 ^[41]	304 ^[42]
Units: percentage of participants
number (not applicable)	44.0	81.9

Notes
[41] - ITT
[42] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[43]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

38.3

Confidence interval

level

95%

sides

2-sided

lower limit

27.9

upper limit

48.6

Notes
[43] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Top of page

End point title

Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data. ITT population was used for this assessment. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.

End point type

Secondary

End point timeframe

Week 52

End point values	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Number of subjects analysed	100 ^[44]	304 ^[45]
Units: percentage of participants
number (not applicable)	21.0	56.3

Notes
[44] - ITT
[45] - ITT

Statistical analysis 1

Statistical analysis description

Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.

Comparison groups

Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[46]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

35.1

Confidence interval

level

95%

sides

2-sided

lower limit

25.7

upper limit

44.6

Notes
[46] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Number of subjects analysed	100 ^[47]	304 ^[48]
Units: percentage of participants
number (not applicable)	21.0	57.6

Notes
[47] - ITT
[48] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab/Ustekinumab (Part B) v Risankizumab/Risankizumab (Part B)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[49]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

36.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

45.9

Notes
[49] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Top of page

End point title

Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[50]

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. ITT population was used for this assessment.

End point type

Secondary

End point timeframe

Week 12

Notes
[50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[51]	304 ^[52]
Units: percentage of participants
number (not applicable)	70.0	86.8

Notes
[51] - ITT
[52] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[53]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

7.4

upper limit

26.6

Notes
[53] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[54]

End point description

End point type

Secondary

End point timeframe

Week 12

Notes
[54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[55]	304 ^[56]
Units: percentage of participants
number (not applicable)	65.0	82.2

Notes
[55] - ITT
[56] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[57]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

17.3

Confidence interval

level

95%

sides

2-sided

lower limit

7.3

upper limit

27.3

Notes
[57] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: Percentage of Participants Achieving DLQI score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Top of page

End point title

Percentage of Participants Achieving DLQI score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A) ^[58]

End point description

End point type

Secondary

End point timeframe

Week 16

Notes
[58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Ustekinumab (Part A)	Risankizumab (Part A)
Number of subjects analysed	100 ^[59]	304 ^[60]
Units: percentage of participants
number (not applicable)	43.0	65.8

Notes
[59] - ITT
[60] - ITT

Statistical analysis 1

Statistical analysis description

Comparison groups

Ustekinumab (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

404

Analysis specification

Pre-specified

Analysis type

other ^[61]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

adjusted difference in percentage

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

11.9

upper limit

Notes
[61] - 95% confedence interval (CI) for adjusted difference of 2 treatment groups, calculated by subtracting % of patients in Ustekinumab group from % of patients in Risankizumab group using Cochran-Mantel-Haenszel test adjusted for strata.

Secondary: PSS Total Score: Change from Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Top of page

End point title

PSS Total Score: Change from Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) ^[62]

End point description

The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert –type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data. ITT population was used for this assessment. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one postbaseline PSS observation on or prior to Week 16.

End point type

Secondary

End point timeframe

Baseline and Week 16

Notes
[62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only those arms for which the comparisons are presented in the clinical trial report thus, those that would yield meaningful results were reported.

End point values	Placebo (Part A)	Risankizumab (Part A)
Number of subjects analysed	83 ^[63]	251 ^[64]
Units: units on a scale
least squares mean (standard error)	0.157 ± 0.3476	-5.608 ± 0.2254

Notes
[63] - ITT
[64] - ITT

Statistical analysis 1

Comparison groups

Placebo (Part A) v Risankizumab (Part A)

Number of subjects included in analysis

334

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001 ^[65]

Method

van Elteren test

Parameter type

Mean difference (final values)

Point estimate

-5.765

Confidence interval

level

95%

sides

2-sided

lower limit

-6.496

upper limit

-5.035

Notes
[65] - P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).

Adverse events

Top of page

Timeframe for reporting adverse events

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 55 weeks).

Adverse event reporting additional description

TES/AEs in Part A are defined as events from first dose of study drug in Part A until prior to first dose in Part B or up to 105 days after last dose of study drug if the participant discontinued in Part A; TEAEs and TESAEs in Part B are defined as events from first dose of study drug in Part B until up to 105 days after last dose of study drug

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Placebo (Part A)

Reporting group description

Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Reporting group title

Ustekinumab (Part A)

Reporting group description

Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Reporting group title

Risankizumab (Part A)

Reporting group description

Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).

Reporting group title

Placebo/Risankizumab (Part B)

Reporting group description

Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Reporting group title

Ustekinumab/Ustekinumab (Part B)

Reporting group description

Participants randomized to receive ustekinumab in Part A continued to receive ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Reporting group title

Risankizumab/Risankizumab (Part B)

Reporting group description

Participants randomized to receive risankizumab in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).

Serious adverse events	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)	Placebo/Risankizumab (Part B)	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 102 (2.94%)	8 / 100 (8.00%)	7 / 304 (2.30%)	3 / 97 (3.09%)	4 / 99 (4.04%)	16 / 297 (5.39%)
number of deaths (all causes)	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	1 / 97 (1.03%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 102 (0.98%)	0 / 100 (0.00%)	1 / 304 (0.33%)	1 / 97 (1.03%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Abortion induced
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Reproductive system and breast disorders
Female genital tract fistula
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 102 (0.98%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 1	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	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	1 / 99 (1.01%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	1 / 99 (1.01%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Schizoaffective disorder
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	1 / 99 (1.01%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Injury, poisoning and procedural complications
Wound complication
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	1 / 97 (1.03%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Wrist fracture
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Angina unstable
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Left ventricular failure
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Prinzmetal angina
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Nervous system disorders
Post herpetic neuralgia
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Ear and labyrinth disorders
Hypoacusis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Gastrointestinal disorders
Enteritis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	1 / 102 (0.98%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	1 / 102 (0.98%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	1 / 97 (1.03%)	1 / 99 (1.01%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	1 / 102 (0.98%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Cellulitis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	1 / 304 (0.33%)	1 / 97 (1.03%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	1 / 97 (1.03%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Sepsis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	1 / 297 (0.34%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Sinusitis
subjects affected / exposed	0 / 102 (0.00%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	0 / 99 (0.00%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0
Tonsillitis
subjects affected / exposed	0 / 102 (0.00%)	0 / 100 (0.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	1 / 99 (1.01%)	0 / 297 (0.00%)
occurrences causally related to treatment / all	0 / 0	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	0 / 0

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

Non-serious adverse events	Placebo (Part A)	Ustekinumab (Part A)	Risankizumab (Part A)	Placebo/Risankizumab (Part B)	Ustekinumab/Ustekinumab (Part B)	Risankizumab/Risankizumab (Part B)
Total subjects affected by non serious adverse events
subjects affected / exposed	16 / 102 (15.69%)	16 / 100 (16.00%)	45 / 304 (14.80%)	25 / 97 (25.77%)	36 / 99 (36.36%)	75 / 297 (25.25%)
Nervous system disorders
Headache
subjects affected / exposed	2 / 102 (1.96%)	2 / 100 (2.00%)	9 / 304 (2.96%)	3 / 97 (3.09%)	5 / 99 (5.05%)	5 / 297 (1.68%)
occurrences all number	2	2	9	3	5	5
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	6 / 102 (5.88%)	1 / 100 (1.00%)	0 / 304 (0.00%)	0 / 97 (0.00%)	1 / 99 (1.01%)	1 / 297 (0.34%)
occurrences all number	6	1	0	0	1	1
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	2 / 102 (1.96%)	6 / 100 (6.00%)	17 / 304 (5.59%)	8 / 97 (8.25%)	11 / 99 (11.11%)	30 / 297 (10.10%)
occurrences all number	2	6	20	10	14	32
Urinary tract infection
subjects affected / exposed	1 / 102 (0.98%)	2 / 100 (2.00%)	1 / 304 (0.33%)	0 / 97 (0.00%)	5 / 99 (5.05%)	3 / 297 (1.01%)
occurrences all number	1	2	1	0	5	4
Viral upper respiratory tract infection
subjects affected / exposed	6 / 102 (5.88%)	6 / 100 (6.00%)	20 / 304 (6.58%)	15 / 97 (15.46%)	18 / 99 (18.18%)	40 / 297 (13.47%)
occurrences all number	7	8	24	17	20	45

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Were there any global substantial amendments to the protocol? Yes

13 May 2016

Anti-drug antibody sampling added to Week 4. Line item biologic therapy changed to psoriasis therapy. % Body surface area involvement added as line item. Remove Week 0. Remove Interactive Response Technology call from Follow-Up 3 Visit. Patient with a positive or suspected history of Psoriatic Arthritis (PsA) will be evaluated via ClASsification of Psoriatic Arthritis. Revised text to specify timing of vital sign measurements and hypersensitivity monitoring at dosing visits. Replaced criteria for eligibility in Open Label Extension study of without having missed more than one study treatment with without early treatment discontinuation. Removed prior to receiving BI 655066. Clarification on how efficacy data will be used on submission as well as additional information on unblinding. Added thrombotic events. Patients that discontinue study medication should complete all study visits and procedures as initially planned. Added region and instructions for injections. Added that dosing injections should be performed within approximately 5 minutes. Added tofacitinib Xeljanz® and apremilast Otezla® Removed efalizumab Raptiva®. Additional medications requiring washout Medication not available. Added absolute PASI of <3 at all visits collected. Revised text to specify the timing of vital sign measurements and hypersensitivity monitoring at dosing visits. Added absolute count to the Differential Manual. Added Activated to Partial Thromboplastin Time. Added test done in clinic for urine pregnancy. Moved creatinine from dipstick urinalysis to urine section. Added albumin/creatinine ratio to urine section. Specified Purified Protein Derivative skin test is not provided or performed by central laboratory. Removed For Japan only, the reason for the decision on causal relationship for unlisted AEs needs to be provided in the eCRF. Removed At visit 2 these questionnaires should be obtained after having the patient randomised. Removed maximum of 2 visits for screening.

11 Oct 2016

Changed BI drug or BI investigational product or BI 655066 to refer to either names for this compound: BI 655066/ ABBV-066/risankizumab. Changed sponsor from Boehringer Ingelheim (BI) to AbbVie in the US and BI for all other participating countries. Changed text to specify Statistical Evaluation will be done by AbbVie according to their SOPs. Updated text to “AbbVie/Boehringer Ingelheim reserves the right to discontinue the trial overall or at a particular trial site at any time for the following reasons”. Changed DNA banking sample storage from Boehringer Ingelheim to AbbVie or a third party delegate (e.g. Boehringer Ingelheim Pharma GmbH & Co. KG; Birkendorfer Str. 65, 88397 Biberach, Germany). Changed text to specify that AbbVie summary tables and listings will be produced and analyses based on AbbVie standards.

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: BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Primary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A).

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)

Secondary: Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving DLQI score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: Percentage of Participants Achieving DLQI score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)

Secondary: PSS Total Score: Change from Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Secondary: PSS Total Score: Change from Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind Trial for Maintenance Use in Moderate to Severe Plaque Type Psoriasis