Trial Outcomes & Findings for Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement (NCT NCT04713592)

Last Updated: 2024-06-14

Results Overview

The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), and scaling of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

174 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2024-06-14

Participant Flow

Eligible participants were randomized at the Baseline visit in a 1:1 ratio to receive either risankizumab 150 mg as a single SC injection, or matching placebo during the Double-blind Period. Study drug administration occurred at Baseline and Week 4. Starting at Week 16, participants received open-label risankizumab 150 mg once every 12 weeks (q12w) at Weeks 16, 28, and 40. The final efficacy evaluation took place at Week 52.

Participant milestones

Participant milestones
Measure	Placebo Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Double-blind Period (Baseline - Week 16) STARTED	87	87	0	0
Double-blind Period (Baseline - Week 16) COMPLETED	81	84	0	0
Double-blind Period (Baseline - Week 16) NOT COMPLETED	6	3	0	0
Open-label Period (Week 16 - Week 52) STARTED	0	0	81	84
Open-label Period (Week 16 - Week 52) Entered Open-label Period and Received Study Drug	0	0	81	81
Open-label Period (Week 16 - Week 52) COMPLETED	0	0	59	61
Open-label Period (Week 16 - Week 52) NOT COMPLETED	0	0	22	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Double-blind Period (Baseline - Week 16) Adverse Event	0	1	0	0
Double-blind Period (Baseline - Week 16) Withdrawal by Subject	6	2	0	0
Open-label Period (Week 16 - Week 52) Adverse Event	0	0	1	2
Open-label Period (Week 16 - Week 52) Withdrawal by Subject	0	0	3	5
Open-label Period (Week 16 - Week 52) Lost to Follow-up	0	0	1	1
Open-label Period (Week 16 - Week 52) Lack of Efficacy	0	0	1	1
Open-label Period (Week 16 - Week 52) Other, not specified	0	0	16	14

Baseline Characteristics

Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. Starting at Week 16, all participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Total n=174 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 14.30 • n=5 Participants	56.9 years STANDARD_DEVIATION 12.93 • n=7 Participants	55.4 years STANDARD_DEVIATION 13.67 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	40 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants	59 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline ppIGA score Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline ppIGA score Almost Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline ppIGA score Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline ppIGA score Moderate	68 Participants n=5 Participants	67 Participants n=7 Participants	135 Participants n=5 Participants
Baseline ppIGA score Severe	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Baseline PPASI score	22.46 units on a scale STANDARD_DEVIATION 12.141 • n=5 Participants	22.48 units on a scale STANDARD_DEVIATION 13.647 • n=7 Participants	22.47 units on a scale STANDARD_DEVIATION 12.878 • n=5 Participants
Baseline sPGA score Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline sPGA score Almost Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline sPGA score Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline sPGA score Moderate	75 Participants n=5 Participants	77 Participants n=7 Participants	152 Participants n=5 Participants
Baseline sPGA score Severe	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Intent-to-Treat (ITT) Population: all randomized participants. Non-Responder Imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16	16.1 percentage of participants Interval 8.4 to 23.8	33.3 percentage of participants Interval 23.4 to 43.2	—	—

PRIMARY outcome

Timeframe: From the first dose of study drug in the Double-blind Period up to 140 days after the last dose; from the first dose of study drug in the Open-label Period up to 140 days after the last dose and the end of study date (up to 60 weeks)

Population: All participants who were randomized and received at least 1 dose of study drug in the Double-blind Period; all participants who received at least 1 dose of study drug in the Open-label Period.

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

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=86 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab n=81 Participants Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab n=81 Participants Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Number of Participants With Treatment-Emergent Adverse Events Any TEAE	20 Participants	25 Participants	29 Participants	40 Participants
Number of Participants With Treatment-Emergent Adverse Events TESAE	0 Participants	5 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

PPASI is a linear combination of percent of surface area of hands and feet that are affected and the severity of erythema, induration, and desquamation with scores ranging from 0 to 72. Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Percentage of Participants Achieving ≥ 75% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 75) Response at Week 16	14.9 percentage of participants Interval 7.5 to 22.4	42.5 percentage of participants Interval 32.1 to 52.9	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Percentage of Participants Achieving ≥ 90% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 90) Response at Week 16	5.7 percentage of participants Interval 0.9 to 10.6	27.6 percentage of participants Interval 18.2 to 37.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of "Clear" or "Almost Clear" (0 or 1) With at Least a 2-point Reduction From Baseline at Week 16	11.5 percentage of participants Interval 4.8 to 18.2	32.2 percentage of participants Interval 22.4 to 42.0	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Risankizumab n=87 Participants Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4.	Placebo/Risankizumab Participants received placebo injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.	Risankizumab/Risankizumab Participants received risankizumab injections during the Double-blind Period. Starting at Week 16, participants received open-label risankizumab 150 mg subcutaneous injections once every 12 weeks (q12w) at Weeks 16, 28, and 40.
Percentage of Participants Achieving 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI 100) Response at Week 16	1.1 percentage of participants Interval 0.0 to 3.4	17.2 percentage of participants Interval 9.3 to 25.2	—	—

Adverse Events

Placebo (Double-blind Period)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Risankizumab (Double-blind Period)

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo/Risankizumab (Open-label Period)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Risankizumab/Risankizumab (Open-label Period)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Double-blind Period) n=87 participants at risk Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period.	Risankizumab (Double-blind Period) n=87 participants at risk Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period.	Placebo/Risankizumab (Open-label Period) n=81 participants at risk Participants received placebo injections during the Double-blind Period and risankizumab injections during the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period.	Risankizumab/Risankizumab (Open-label Period) n=84 participants at risk Participants received risankizumab injections during both the Double-blind Period and the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period.
Cardiac disorders ANGINA UNSTABLE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/84 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/84 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/84 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
General disorders CHEST PAIN	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Nervous system disorders SYNCOPE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.2% 1/84 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/87 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	1.1% 1/87 • Number of events 1 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/81 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	0.00% 0/84 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.

Other adverse events

Other adverse events
Measure	Placebo (Double-blind Period) n=87 participants at risk Participants received subcutaneous placebo injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period.	Risankizumab (Double-blind Period) n=87 participants at risk Participants received risankizumab 150 mg subcutaneous injections during the 16-week Double-blind Period at Baseline (Day 1) and Week 4. AEs and SAEs were collected from the time of informed consent and during the Double-blind period, as long as it did not exceed the start date of the Open-label period.	Placebo/Risankizumab (Open-label Period) n=81 participants at risk Participants received placebo injections during the Double-blind Period and risankizumab injections during the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period.	Risankizumab/Risankizumab (Open-label Period) n=84 participants at risk Participants received risankizumab injections during both the Double-blind Period and the Open-label Period. AEs and SAEs were collected from the start date of the Open-label period.
Infections and infestations COVID-19	2.3% 2/87 • Number of events 2 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	2.3% 2/87 • Number of events 2 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	9.9% 8/81 • Number of events 10 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.	14.3% 12/84 • Number of events 13 • All-cause mortality and adverse events based on Intent-to-Treat (ITT) during the two study periods from the time of informed consent. Those randomized to Placebo in the Double-blind Period who didn't continue into the Open-label Period weren't included in Open-label Period ITT population. Median time on follow-up was 112 days for placebo and risankizumab groups during the Double-blind Period and 309 days for placebo/risankizumab and risankizumab/risankizumab groups during the Open-label Period.

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