Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis (NCT NCT03022045)

NCT ID: NCT03022045

Last Updated: 2021-11-18

Results Overview

GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count \[WBC\], serum C-reactive protein \[CRP\], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and \< 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 18 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2021-11-18

Participant Flow

A total of 18 subjects were enrolled; 1 subject failed screening and are excluded from the analyses.

Participant milestones

Measure	Risankizumab 75 mg Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Risankizumab 150 mg Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Overall Study STARTED	9	8
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Risankizumab 75 mg Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Risankizumab 150 mg Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Baseline characteristics by cohort

Measure	Risankizumab 75 mg n=9 Participants Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Risankizumab 150 mg n=8 Participants Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Total n=17 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 20.76 • n=5 Participants	44.1 years STANDARD_DEVIATION 20.13 • n=7 Participants	48.40 years STANDARD_DEVIATION 20.24 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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

PRIMARY outcome

Timeframe: Week 16

GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count [WBC], serum C-reactive protein [CRP], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.

Outcome measures

Measure	GPP Risankizumab 75 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16	100 percentage of participants	100 percentage of participants

PRIMARY outcome

Timeframe: Week 16

EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data.

Outcome measures

Measure	GPP Risankizumab 75 mg n=5 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 52

GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to JDA total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, WBC, serum CRP, and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

EP Clinical Response, defined as at least "Minimally Improved" in CGI-GI for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16

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.

Outcome measures

Measure	GPP Risankizumab 75 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16	100 percentage of participants	75 percentage of participants

SECONDARY outcome

Timeframe: Week 16

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. NRI was used for missing data.

Outcome measures

Measure	GPP Risankizumab 75 mg n=5 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 Participants Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Percentage of Participants With EP Achieving PASI90 at Week 16	60 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 52

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

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.

Outcome measures

Outcome data not reported

Adverse Events

GPP Risankizumab 75 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

GPP Risankizumab 150 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

EP Risankizumab 75 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

EP Risankizumab 150 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	GPP Risankizumab 75 mg n=4 participants at risk Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 participants at risk Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	EP Risankizumab 75 mg n=5 participants at risk Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	EP Risankizumab 150 mg n=4 participants at risk Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Endocrine disorders Adrenal insufficiency	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Hepatobiliary disorders Alcoholic liver disease	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Renal and urinary disorders Calculus urinary	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.

Other adverse events

Measure	GPP Risankizumab 75 mg n=4 participants at risk Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	GPP Risankizumab 150 mg n=4 participants at risk Participants with generalized pustular psoriasis (GPP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	EP Risankizumab 75 mg n=5 participants at risk Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	EP Risankizumab 150 mg n=4 participants at risk Participants with erythrodermic psoriasis (EP) randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
General disorders Inflammation	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
General disorders Pyrexia	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Bronchitis viral	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Ear infection	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Otitis media	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	50.0% 2/4 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Infections and infestations Viral upper respiratory tract infection	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	60.0% 3/5 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	75.0% 3/4 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Investigations Gamma-glutamyltransferase increased	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	50.0% 2/4 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Psychiatric disorders Depression	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	20.0% 1/5 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Erythema	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	25.0% 1/4 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.	0.00% 0/4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 105 days after the last dose of study drug (up to 187 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening from the time that the first dose of risankizumab is administered until 105 days after the last dose of study drug.

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• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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