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Clinical Trial Results:
BI 655066 [risankizumab] versus placebo in a multicenter randomized double-blind study in participants with moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawal and re-treatment.

Summary
EudraCT number	2014-005102-38
Trial protocol	DE BE CZ
Global end of trial date	26 Jul 2018

Results information
Results version number	v2(current)
This version publication date	11 Nov 2019
First version publication date	01 Aug 2019
Other versions	v1
Version creation reason

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

1311.4

ISRCTN number

US NCT number

NCT02672852

WHO universal trial number (UTN)

Sponsor organisation name

Boehringer Ingelheim

Sponsor organisation address

Binger Strasse 173, Ingelheim am Rhein, Germany, Ingelheim am Rhein

Public contact

QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com

Scientific contact

QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, 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

26 Jul 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

02 Aug 2017

Global end of trial reached?

Yes

Global end of trial date

26 Jul 2018

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 with placebo in participants with moderate to severe chronic plaque psoriasis, the maintenance of response following drug withdrawal after Week 28 through Week 104, and the response after re-treatment in participants who experienced relapse after drug withdrawal and were re-treated with risankizumab. In addition, this study was designed to assess the pharmacokinetics (PK) of risankizumab, emergence of anti-drug antibodies, and the effect of anti-drug antibodies on efficacy and safety.

Protection of trial subjects

Only participants that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All participants were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all participants was adhered to throughout the trial conduct. Rescue medication was allowed for all participants as required.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 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: 32

Country: Number of subjects enrolled

Belgium: 1

Country: Number of subjects enrolled

Canada: 117

Country: Number of subjects enrolled

Czech Republic: 15

Country: Number of subjects enrolled

France: 12

Country: Number of subjects enrolled

Germany: 27

Country: Number of subjects enrolled

Japan: 15

Country: Number of subjects enrolled

Korea, Republic of: 56

Country: Number of subjects enrolled

United States: 288

Worldwide total number of subjects

563

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)

493

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.

Period 1 title

Part A1

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Blinding implementation details

This was double-blind part of the study.

Are arms mutually exclusive

Yes

Placebo (Part A1)

Arm description

Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

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

Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Risankizumab (Part A1)

Arm description

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Arm type

Experimental

Investigational medicinal product name

Rrisankizumab

Investigational medicinal product code

Other name

BI 655066

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Number of subjects in period 1 ^[1]	Placebo (Part A1)	Risankizumab (Part A1)
Started	100	407
Completed	97	403
Not completed	3	4
Consent withdrawn by subject	1	1
Adverse event, non-fatal	-	1
Disease worsening	1	-
Lost to follow-up	1	2

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 patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

Period 2 title

Part A2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Blinding implementation details

This was double-blind part of the study.

Are arms mutually exclusive

Yes

Placebo/Risankizumab Part A2/Part B

Arm description

Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg by subcutaneous injection at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B).

Arm type

Placebo

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

BI 655066

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Risankizumab/Risankizumab Part A2

Arm description

Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg by subcutaneous injection at Weeks 16 (Part A2).

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

BI 655066

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg by subcutaneous injection at Weeks 16 (Part A2).

Number of subjects in period 2 ^[2]	Placebo/Risankizumab Part A2/Part B	Risankizumab/Risankizumab Part A2
Started	93	403
Completed	83	399
Not completed	10	4
Consent withdrawn by subject	1	-
Adverse event, non-fatal	3	-
Not entered in Part B	-	4
Not specified	3	-
Disease worsening	1	-
Lost to follow-up	2	-

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: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

Period 3 title

Part B

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Blinding implementation details

This was double-blind part of the study.

Are arms mutually exclusive

Yes

Risankizumab/Placebo (Part B; Rerandomized Responders)

Arm description

Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo by subcutaneous injection at Week 28 and every 12 weeks up to Week 88 (Part B).

Arm type

Experimental

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

Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Arm description

Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg by subcutaneous injection at Week 28 and every 12 weeks up to Week 88 (Part B).

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

BI 655066

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Risankizumab/Risankizumab Part B (Nonresponders)

Arm description

Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg by subcutaneous injection at Week 28 and every 12 weeks up to Week 88 (Part B).

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

BI 655066

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 3 ^[3]	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)	Risankizumab/Risankizumab Part B (Nonresponders)
Started	225	111	63
Completed	209	100	51
Not completed	16	11	12
Consent withdrawn by subject	5	-	7
Not specified	4	1	2
Other adverse event	3	5	1
Worsening pre-existing condition	-	1	-
Disease worsening	1	-	1
Lost to follow-up	3	4	1

Notes
[3] - 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: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

Baseline characteristics

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Reporting group title

Placebo (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group title

Risankizumab (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group values	Placebo (Part A1)	Risankizumab (Part A1)	Total
Number of subjects	100	407	507
Age categorical
Units: Subjects
Age Continuous
Intent to Treat (ITT) Population in Part A1 (ITT_A1): All participants who were randomized at Baseline
Units: years
arithmetic mean (standard deviation)	47.9 ( 13.78 )	49.6 ( 13.17 )	-
Sex: Female, Male
ITT_A1
Units: Subjects
Female	27	124	151
Male	73	283	356
Ethnicity (NIH/OMB)
ITT_A1
Units: Subjects
Hispanic or Latino	11	45	56
Not Hispanic or Latino	89	362	451
Unknown or Not Reported	0	0	0
Race (NIH/OMB)
ITT_A1
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	15	64	79
Native Hawaiian or Other Pacific Islander	1	3	4
Black or African American	2	18	20
White	82	320	402
More than one race	0	2	2
Unknown or Not Reported	0	0	0

End points

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Reporting group title

Placebo (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group title

Risankizumab (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group title

Placebo/Risankizumab Part A2/Part B

Reporting group description

Reporting group title

Risankizumab/Risankizumab Part A2

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg by subcutaneous injection at Weeks 16 (Part A2).

Reporting group title

Risankizumab/Placebo (Part B; Rerandomized Responders)

Reporting group description

Reporting group title

Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Reporting group description

Reporting group title

Risankizumab/Risankizumab Part B (Nonresponders)

Reporting group description

Primary: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

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End point title

Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

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. Non-responder imputation (NRI) was used for missing data. Intent to treat (ITT) Population in Part A1(ITT_A1): all participants who were randomized at Baseline.

End point type

Primary

End point timeframe

Baseline, Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[1]	407 ^[2]
Units: Percentage of participants
number (not applicable)	2.0	73.2

Notes
[1] - ITT_A1
[2] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).

Comparison groups

Risankizumab (Part A1) v Placebo (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

70.8

Confidence interval

level

95%

sides

2-sided

lower limit

65.7

upper limit

Primary: Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

Top of page

End point title

Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

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.

End point type

Primary

End point timeframe

Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[3]	407 ^[4]
Units: Percentage of participants
number (not applicable)	7.0	83.5

Notes
[3] - ITT_A1
[4] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).

Comparison groups

Placebo (Part A1) v Risankizumab (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

76.5

Confidence interval

level

95%

sides

2-sided

lower limit

70.4

upper limit

82.5

Primary: Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

Top of page

End point title

Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

End point description

End point type

Primary

End point timeframe

Week 52

End point values	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Number of subjects analysed	225 ^[5]	111 ^[6]
Units: Percentage of participants
number (not applicable)	61.3	87.4

Notes
[5] - ITT_B_R
[6] - ITT_B_R

Statistical Analysis 1

Statistical analysis description

Comparison groups

Risankizumab/Placebo (Part B; Rerandomized Responders) v Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

25.9

Confidence interval

level

95%

sides

2-sided

lower limit

17.3

upper limit

34.6

Secondary: Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

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 75% 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.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[7]	407 ^[8]
Units: Percentage of participants
number (not applicable)	8.0	88.7

Notes
[7] - ITT_A1
[8] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A1) v Risankizumab (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

80.6

Confidence interval

level

95%

sides

2-sided

lower limit

74.5

upper limit

86.6

Secondary: Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

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End point title

Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

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.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[9]	407 ^[10]
Units: Percentage of participants
number (not applicable)	1.0	47.2

Notes
[9] - ITT_A1
[10] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A1) v Risankizumab (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

45.5

Confidence interval

level

95%

sides

2-sided

lower limit

40.3

upper limit

50.8

Secondary: Percentage of Participants Achieving an sPGA score of clear at Week 16

Top of page

End point title

Percentage of Participants Achieving an sPGA score of clear at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[11]	407 ^[12]
Units: Percentage of participants
number (not applicable)	1.0	46.4

Notes
[11] - ITT_A1
[12] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A1) v Risankizumab (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

44.8

Confidence interval

level

95%

sides

2-sided

lower limit

39.5

upper limit

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

Top of page

End point title

Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

End point description

The 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 1 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. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo (Part A1)	Risankizumab (Part A1)
Number of subjects analysed	100 ^[13]	407 ^[14]
Units: Percentage of participants
number (not applicable)	3.0	65.4

Notes
[13] - ITT_A1
[14] - ITT_A1

Statistical Analysis 1

Statistical analysis description

Comparison groups

Placebo (Part A1) v Risankizumab (Part A1)

Number of subjects included in analysis

507

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

62.1

Confidence interval

level

95%

sides

2-sided

lower limit

56.4

upper limit

67.9

Secondary: Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

Top of page

End point title

Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

End point description

End point type

Secondary

End point timeframe

Week 104

End point values	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Number of subjects analysed	225 ^[15]	111 ^[16]
Units: Percentage of participants
number (not applicable)	7.1	81.1

Notes
[15] - ITT_B_R
[16] - ITT_B_R

Statistical Analysis 1

Statistical analysis description

Comparison groups

Risankizumab/Placebo (Part B; Rerandomized Responders) v Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

73.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

81.9

Secondary: Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

Top of page

End point title

Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

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 75% 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.

End point type

Secondary

End point timeframe

Week 52

End point values	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Number of subjects analysed	225 ^[17]	111 ^[18]
Units: Percentage of participants
number (not applicable)	71.6	92.8

Notes
[17] - ITT_B_R
[18] - ITT_B_R

Statistical Analysis 1

Statistical analysis description

Comparison groups

Risankizumab/Placebo (Part B; Rerandomized Responders) v Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

21.2

Confidence interval

level

95%

sides

2-sided

lower limit

13.7

upper limit

28.7

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Number of subjects analysed	225 ^[19]	111 ^[20]
Units: Percentage of participants
number (not applicable)	52.4	85.6

Notes
[19] - ITT_B_R
[20] - ITT_B_R

Statistical Analysis 1

Statistical analysis description

Comparison groups

Risankizumab/Placebo (Part B; Rerandomized Responders) v Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

33.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

42.2

Secondary: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

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End point title

Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

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.

End point type

Secondary

End point timeframe

Week 52

End point values	Risankizumab/Placebo (Part B; Rerandomized Responders)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)
Number of subjects analysed	225 ^[21]	111 ^[22]
Units: Percentage of participants
number (not applicable)	30.2	64.0

Notes
[21] - ITT_B_R
[22] - ITT_B_R

Statistical Analysis 1

Statistical analysis description

Comparison groups

Risankizumab/Placebo (Part B; Rerandomized Responders) v Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Number of subjects included in analysis

336

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

33.7

Confidence interval

level

95%

sides

2-sided

lower limit

23.2

upper limit

44.2

Adverse events

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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 103 weeks).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Placebo (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group title

Risankizumab (Part A1)

Reporting group description

Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).

Reporting group title

Risankizumab/Risankizumab (Part B; Rerandomized Responders)

Reporting group description

Reporting group title

Risankizumab/Placebo (Part B; Rerandomized Responders)

Reporting group description

Reporting group title

Any Risankizumab

Reporting group description

Participants who received at least one dose of risankizumab during the study.

Serious adverse events	Placebo (Part A1)	Risankizumab (Part A1)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)	Risankizumab/Placebo (Part B; Rerandomized Responders)	Any Risankizumab
Total subjects affected by serious adverse events
subjects affected / exposed	8 / 100 (8.00%)	8 / 407 (1.97%)	13 / 111 (11.71%)	17 / 225 (7.56%)	55 / 500 (11.00%)
number of deaths (all causes)	0	0	2	0	4
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Basal cell carcinoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	3 / 500 (0.60%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer stage I
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Gastric cancer
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Hepatic cancer metastatic
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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 / 1
Intestinal adenocarcinoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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 / 1
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Malignant melanoma in situ
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Metastases to lymph nodes
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Prostate cancer
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	2 / 225 (0.89%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 2	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	1 / 225 (0.44%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Surgical and medical procedures
Alcohol detoxification
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
General disorders and administration site conditions
Death
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cervical dysplasia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Menometrorrhagia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Chylothorax
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Pneumothorax
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Pulmonary embolism
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Psychiatric disorders
Alcoholism
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Anxiety
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Delirium tremens
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Insomnia
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Somatic symptom disorder
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Suicidal ideation
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Burns second degree
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Fall
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Incisional hernia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Muscle strain
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Open globe injury
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Congenital, familial and genetic disorders
Benign familial pemphigus
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Huntington's disease
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Aortic valve disease mixed
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Atrial fibrillation
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Cardiac arrest
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Coronary artery disease
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Intracardiac thrombus
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Basal ganglia infarction
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Carotid artery occlusion
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Cerebral infarction
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dementia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Encephalitis autoimmune
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Epilepsy
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
Hemiplegia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Seizure
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tension headache
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Transient ischaemic attack
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Blood and lymphatic system disorders
Disseminated intravascular coagulation
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Eye disorders
Amaurosis fugax
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Diabetic retinopathy
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Retinal detachment
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Alcoholic pancreatitis
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Haemorrhoids
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Inguinal hernia
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Intestinal obstruction
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Bile duct stone
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Cholecystitis acute
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver injury
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	0 / 500 (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
Skin and subcutaneous tissue disorders
Skin ulcer
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Bursitis
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Gouty tophus
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Jaw cyst
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Rotator cuff syndrome
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Abscess neck
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Appendicitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Bronchitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Cellulitis
subjects affected / exposed	1 / 100 (1.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Meningitis bacterial
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	1 / 111 (0.90%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Periorbital cellulitis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	1 / 225 (0.44%)	0 / 500 (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
Sepsis
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	2 / 500 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 100 (0.00%)	0 / 407 (0.00%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
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
Dehydration
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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
Hypokalaemia
subjects affected / exposed	0 / 100 (0.00%)	1 / 407 (0.25%)	0 / 111 (0.00%)	0 / 225 (0.00%)	1 / 500 (0.20%)
occurrences causally related to treatment / all	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

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

Non-serious adverse events	Placebo (Part A1)	Risankizumab (Part A1)	Risankizumab/Risankizumab (Part B; Rerandomized Responders)	Risankizumab/Placebo (Part B; Rerandomized Responders)	Any Risankizumab
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 100 (17.00%)	52 / 407 (12.78%)	52 / 111 (46.85%)	92 / 225 (40.89%)	242 / 500 (48.40%)
Nervous system disorders
Headache
subjects affected / exposed	0 / 100 (0.00%)	14 / 407 (3.44%)	8 / 111 (7.21%)	7 / 225 (3.11%)	34 / 500 (6.80%)
occurrences all number	0	15	15	9	47
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	5 / 100 (5.00%)	2 / 407 (0.49%)	0 / 111 (0.00%)	8 / 225 (3.56%)	4 / 500 (0.80%)
occurrences all number	6	2	0	8	4
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	2 / 100 (2.00%)	7 / 407 (1.72%)	10 / 111 (9.01%)	13 / 225 (5.78%)	35 / 500 (7.00%)
occurrences all number	2	7	10	16	37
Back pain
subjects affected / exposed	0 / 100 (0.00%)	2 / 407 (0.49%)	4 / 111 (3.60%)	12 / 225 (5.33%)	28 / 500 (5.60%)
occurrences all number	0	2	7	13	31
Infections and infestations
Influenza
subjects affected / exposed	1 / 100 (1.00%)	3 / 407 (0.74%)	7 / 111 (6.31%)	8 / 225 (3.56%)	22 / 500 (4.40%)
occurrences all number	1	3	8	10	24
Nasopharyngitis
subjects affected / exposed	6 / 100 (6.00%)	21 / 407 (5.16%)	23 / 111 (20.72%)	45 / 225 (20.00%)	116 / 500 (23.20%)
occurrences all number	6	21	36	53	170
Upper respiratory tract infection
subjects affected / exposed	5 / 100 (5.00%)	6 / 407 (1.47%)	16 / 111 (14.41%)	23 / 225 (10.22%)	77 / 500 (15.40%)
occurrences all number	5	6	19	29	97

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Were there any global substantial amendments to the protocol? Yes

11 Mar 2016

Added Infection Testing (Tuberculosis (TB)) to Screening. Several footnotes added. Vital Status information updated. Justification provide for Section 2.3. Section 3.1.2 and 3.1.3 clarified. Section 3.3.4.1, 5.1.3, 7.5 and 4.1.4 updated. Added tofacitinib (Xeljanz®), apremilast (Otezla®) and removed efalizumab (Raptiva®)in Table 4.2.2.1:1. Added a paragraph for TB testing in Section 6.2. Maximum of 2 visits a patient may need for screening was deleted. Updated Section 6.2.3, Follow-up Period and Trial Completion. Separated out re-randomized hypothesis from hypotheses tested on all randomized patients. Definition of analysis sets clarified. Wording “IPV’s would be provided in trial statistical analysis plan (TSAP) and added verbiage about IPVs and PPS sensitivity analyses” and data monitoring committee (DMC) information deleted. Added “The hypothesis tests as described in Section 7.2 will be repeated on the PPS or RRSPPS populations, as appropriate". Order of Psoriatic arthritis (PsA) assessments changed at Visit 2. Investigator Brochure document ID was changed. References added. Added risankizumab after BI 655066.

28 Jul 2016

Footnotes were revised. Abbreviation added and corrected. Figure 3.1:1 was replaced with new trial design. Summary and Overall trial design and plan were updated. Section 3.3.4.2 updated. Section 4.1.2 re-written according to new study design to be consistent with section 3.1. 650666 changed to 655066 in section 4.1.3. Section 4.1.4 Drug assignment and administration of doses for each patient updated. Section 4.1.5.1 Blinding and 7.6 Randomisation re-written according to new study design to be consistent with section 3.1, clarifying the criteria for receiving open label. Deleted reference to Section 3.3.3, and corrected to 3.3.2. Text added in section 5.1.3 Further endpoints. Section 5.3.2 Vital Signs updated to specify timing of vitals relative to injection times and also timing of monitoring hypersensitivity with respect to injection times. Added absolute count to differential, activated to aPTT, calculated to LDL, creatinineand Albumin/creatinine ratio to urinalysis. Deleted “MB” from Troponin reflex and creatinine” from urinalysis stix in Table 5.3.3:1 laboratory tests. Added paragraph to note that efficacy questionnaires are direct data capture on an electronic device. Wording revised due to implementation of continuing blinded treatment. Further instructions given for staying in the trial or terminating from the trial when a patient ends treatment early updated. Added “and who have not discontinued drug prematurely” to definition of trial completion. Section 7.1, Section 7.3 Planned Analyses, 7.3.3 Further endpoint analyses, 7.3.3 Further endpoint analyses and 7.5 Handling of Missing Data updated. In Table 7.7.1 changed PBO to “placebo”. Wording from “scored” to “scores” corrected. Response categories for Dermatology life quality index (DLQI) updated. Blind break for week 28 responders was updated.

11 Oct 2016

The compound name was revised to add “ABBV-066” to BI 655066 (risankizumab). Changed sponsor from Boehringer Ingelheim (BI) to AbbVie in the USA and BI for non-USA participating countries. 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 [risankizumab] versus placebo in a multicenter randomized double-blind study in participants with moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawal and re-treatment.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

Primary: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

Primary: Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

Primary: Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

Primary: Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

Primary: Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

Secondary: Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

Secondary: Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

Secondary: Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

Secondary: Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear at Week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear at Week 16

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

Secondary: Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

Secondary: Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

Secondary: Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

Secondary: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

Secondary: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Outside EU/EEA

Clinical trials

Clinical Trial Results: BI 655066 [risankizumab] versus placebo in a multicenter randomized double-blind study in participants with moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawal and re-treatment.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

Primary: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) score (PASI90) from baseline to week 16

Primary: Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

Primary: Percentage of Participants Achieving static Physician Global Assessment (sPGA) score of clear or almost clear at week 16

Primary: Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

Primary: Percentage of Participants Achieving sPGA score of clear or almost clear at week 52

Secondary: Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

Secondary: Percentage of Participants Achieving 75% Improvement in PASI score (PASI75) at week 16

Secondary: Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

Secondary: Percentage of Participants Achieving 100% improvement in PASI score (PASI100) at week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear at Week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear at Week 16

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1 at Week 16

Secondary: Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

Secondary: Percentage of Participants Achieving an sPGA score of clear or almost clear at Week 104

Secondary: Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

Secondary: Percentage of Participants Achieving 75% improvement in PASI Score (PASI75) at Week 52

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52

Secondary: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

Secondary: Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
BI 655066 [risankizumab] versus placebo in a multicenter randomized double-blind study in participants with moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with randomized withdrawal and re-treatment.