Trial Outcomes & Findings for Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease. (NCT NCT02031276)

NCT ID: NCT02031276

Last Updated: 2018-11-23

Results Overview

The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: \< 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and \> 450 indicates severely active disease. CDAI clinical remission is defined as CDAI \< 150 at Week 12. Nonresponder imputation (NRI): missing values were counted as nonresponders.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 121 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2018-11-23

Participant Flow

Participants were randomized to 1 of 3 double-blind treatment arms in Period 1; those who achieved deep remission in Period 1 entered Period 2 washout; those who did not achieve deep remission in Period 1 entered Period 2 open-label (OL) treatment. Participants who were in clinical remission at the end of Period 2 continued to Period 3 OL treatment

Participant milestones

Measure	Double-blind Placebo IV Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 200 mg IV Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 600 mg IV Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
Period 1 Double-blind IV STARTED	39	41	41
Period 1 Double-blind IV COMPLETED	33	35	40
Period 1 Double-blind IV NOT COMPLETED	6	6	1
Period 2 Open-label Risankizumab IV STARTED	33	35	39
Period 2 Open-label Risankizumab IV COMPLETED	29	33	38
Period 2 Open-label Risankizumab IV NOT COMPLETED	4	2	1
Period 3 Open-label Risankizumab SC STARTED	19	22	21
Period 3 Open-label Risankizumab SC COMPLETED	16	19	19
Period 3 Open-label Risankizumab SC NOT COMPLETED	3	3	2

Reasons for withdrawal

Measure	Double-blind Placebo IV Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 200 mg IV Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 600 mg IV Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.
Period 1 Double-blind IV Adverse Event	6	5	1
Period 1 Double-blind IV Other	0	1	0
Period 2 Open-label Risankizumab IV Adverse Event	1	0	0
Period 2 Open-label Risankizumab IV Withdrawal by Subject	3	0	0
Period 2 Open-label Risankizumab IV Other	0	2	1
Period 3 Open-label Risankizumab SC Adverse Event	0	2	0
Period 3 Open-label Risankizumab SC Protocol Violation	2	0	0
Period 3 Open-label Risankizumab SC Withdrawal by Subject	1	1	1
Period 3 Open-label Risankizumab SC Other	0	0	1

Baseline Characteristics

Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.

Baseline characteristics by cohort

Measure	Double-blind Placebo IV n=39 Participants Participants randomized in Period 1 to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 200 mg IV n=41 Participants Participants randomized in Period 1 to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Double-blind Risankizumab 600 mg IV n=41 Participants Participants randomized in Period 1 to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks in Period 1, followed by open-label risankizumab 600 mg IV in Period 2, then open-label risankizumab 180 mg by subcutaneous (SC) injection in Period 3.	Total n=121 Participants Total of all reporting groups
Age, Continuous	35.5 years STANDARD_DEVIATION 13.86 • n=5 Participants	38.8 years STANDARD_DEVIATION 13.27 • n=7 Participants	39.9 years STANDARD_DEVIATION 13.26 • n=5 Participants	38.1 years STANDARD_DEVIATION 13.48 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	47 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set-Period 1 (FAS-P1): All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: < 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and > 450 indicates severely active disease. CDAI clinical remission is defined as CDAI < 150 at Week 12. Nonresponder imputation (NRI): missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12	15.4 percentage of participants Interval 5.9 to 30.5	19.5 percentage of participants Interval 8.8 to 34.9	36.6 percentage of participants Interval 22.1 to 53.1	28.0 percentage of participants Interval 18.7 to 39.1

SECONDARY outcome

Timeframe: Week 12

Population: FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: < 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and > 450 indicates severely active disease. CDAI clinical response is defined as either a CDAI < 150 or a CDAI reduction from Baseline of at least 100 points at Week 12. NRI: missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving CDAI Clinical Response at Week 12	23.1 percentage of participants Interval 11.1 to 39.3	31.7 percentage of participants Interval 18.1 to 48.1	41.5 percentage of participants Interval 26.3 to 57.9	36.6 percentage of participants Interval 26.2 to 48.0

SECONDARY outcome

Timeframe: Week 12

Population: FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The results of the individual segments of the colon are divided by the number of segments investigated; the presence of stenosis increases the score at the end of the computation. CDEIS remission is defined as a CDEIS ≤ 4 (or, for patients with initial isolated ileitis, a CDEIS ≤ 2) at Week 12. NRI: missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission at Week 12	2.6 percentage of participants Interval 0.1 to 13.5	9.8 percentage of participants Interval 2.7 to 23.1	19.5 percentage of participants Interval 8.8 to 34.9	14.6 percentage of participants Interval 7.8 to 24.2

SECONDARY outcome

Timeframe: Week 12

Population: FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The results of the individual segments of the colon are divided by the number of segments investigated; the presence of stenosis increases the score at the end of the computation. CDEIS response is defined as defined as ≥ 50% reduction of CDEIS from Baseline to Week 12. NRI: missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving CDEIS Response at Week 12	12.8 percentage of participants Interval 4.3 to 27.4	26.8 percentage of participants Interval 14.2 to 42.9	36.6 percentage of participants Interval 22.1 to 53.1	31.7 percentage of participants Interval 21.9 to 42.9

SECONDARY outcome

Timeframe: Week 12

Population: FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

Mucosal healing was defined as the absence of mucosal ulceration, i.e., a CDEIS ulceration sub-score (deep ulceration, superficial ulceration, ulcerated stenosis) of 0 at Week 12. NRI: missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving Mucosal Healing at Week 12	2.6 percentage of participants Interval 0.1 to 13.5	2.4 percentage of participants Interval 0.1 to 12.9	7.3 percentage of participants Interval 1.5 to 19.9	4.9 percentage of participants Interval 1.3 to 12.0

SECONDARY outcome

Timeframe: Week 12

Population: FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).

Deep remission is defined as clinical remission (CDAI < 150) AND CDEIS remission (CDEIS ≤ 4, or ≤ 2 in participants with initial isolated ileitis) at Week 12. NRI: missing values were counted as nonresponders.

Outcome measures

Measure	Double-blind Placebo IV (Period 1) n=39 Participants Participants randomized to receive double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 Participants Participants randomized to receive double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 + 600 mg IV (Period 1) n=82 Participants Participants randomized to receive double-blind risankizumab 200 mg and 600 mg by intravenous (IV) injection for 12 weeks.
Percentage of Participants Achieving Deep Remission at Week 12	0 percentage of participants Interval 0.0 to 9.0	2.4 percentage of participants Interval 0.1 to 12.9	12.2 percentage of participants Interval 4.1 to 26.2	7.3 percentage of participants Interval 2.7 to 15.2

Adverse Events

Double-blind Placebo IV (Period 1)

Serious events: 13 serious events

Other events: 28 other events

Deaths: 0 deaths

Double-blind Risankizumab 200 mg IV (Period 1)

Serious events: 10 serious events

Other events: 25 other events

Deaths: 0 deaths

Double-blind Risankizumab 600 mg IV (Period 1)

Serious events: 4 serious events

Other events: 21 other events

Deaths: 0 deaths

Open-label Risankizumab 600 mg IV (Period 2)

Serious events: 11 serious events

Other events: 48 other events

Deaths: 0 deaths

Open-label Risankizumab 180 mg SC (Period 3)

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

All Risankizumab

Serious events: 31 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Measure	Double-blind Placebo IV (Period 1) n=39 participants at risk Participants received double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 participants at risk Participants received double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 participants at risk Participants administered double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Open-label Risankizumab 600 mg IV (Period 2) n=101 participants at risk Participants administered open-label risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Open-label Risankizumab 180 mg SC (Period 3) n=62 participants at risk Participants administered open-label risankizumab 600 mg by subcutaneous (SC) injection for 12 weeks.	All Risankizumab n=115 participants at risk Participants administered at least one dose of risankizumab.
Blood and lymphatic system disorders ANAEMIA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Blood and lymphatic system disorders NEUTROPENIA	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Cardiac disorders TACHYCARDIA	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Eye disorders BLINDNESS TRANSIENT	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Eye disorders DIPLOPIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders ANAL FISTULA	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders APHTHOUS ULCER	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders CROHN'S DISEASE	12.8% 5/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.1% 7/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders INTESTINAL OBSTRUCTION	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.6% 3/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders INTESTINAL PERFORATION	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.7% 2/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders PROCTALGIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.6% 3/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders ASTHENIA	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders PAIN	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders PYREXIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Hepatobiliary disorders CHOLELITHIASIS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Immune system disorders ANAPHYLACTIC REACTION	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations ABDOMINAL ABSCESS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations ANAL ABSCESS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations APPENDICITIS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations INCISION SITE ABSCESS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations OSTEOMYELITIS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations PNEUMONIA	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations RECTAL ABSCESS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations VAGINAL ABSCESS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Investigations BLOOD MAGNESIUM DECREASED	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders MALNUTRITION	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.7% 2/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders CEREBROSPINAL FLUID LEAKAGE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders HEADACHE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders HEMIPARESIS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders MIGRAINE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Psychiatric disorders PSYCHIATRIC DECOMPENSATION	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Psychiatric disorders SUICIDE ATTEMPT	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Renal and urinary disorders RENAL COLIC	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Renal and urinary disorders RENAL FAILURE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Surgical and medical procedures ABORTION INDUCED	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Vascular disorders CIRCULATORY COLLAPSE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Vascular disorders DEEP VEIN THROMBOSIS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).

Other adverse events

Measure	Double-blind Placebo IV (Period 1) n=39 participants at risk Participants received double-blind placebo for risankizumab by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 200 mg IV (Period 1) n=41 participants at risk Participants received double-blind risankizumab 200 mg by intravenous (IV) injection for 12 weeks.	Double-blind Risankizumab 600 mg IV (Period 1) n=41 participants at risk Participants administered double-blind risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Open-label Risankizumab 600 mg IV (Period 2) n=101 participants at risk Participants administered open-label risankizumab 600 mg by intravenous (IV) injection for 12 weeks.	Open-label Risankizumab 180 mg SC (Period 3) n=62 participants at risk Participants administered open-label risankizumab 600 mg by subcutaneous (SC) injection for 12 weeks.	All Risankizumab n=115 participants at risk Participants administered at least one dose of risankizumab.
Blood and lymphatic system disorders ANAEMIA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	5.2% 6/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders ABDOMINAL PAIN	12.8% 5/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	14.6% 6/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.8% 4/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	10.9% 11/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	8.1% 5/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	18.3% 21/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.8% 3/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.0% 8/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders CROHN'S DISEASE	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.5% 4/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.5% 4/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders DIARRHOEA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.0% 4/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.8% 9/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders HAEMATOCHEZIA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.5% 4/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders NAUSEA	10.3% 4/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	22.0% 9/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.8% 4/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	5.9% 6/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	15.7% 18/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Gastrointestinal disorders VOMITING	10.3% 4/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.8% 4/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.9% 7/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.6% 11/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders ASTHENIA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.8% 4/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.8% 9/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders FATIGUE	7.7% 3/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	8.1% 5/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.0% 8/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders INFLUENZA LIKE ILLNESS	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.6% 3/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders MALAISE	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.0% 4/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.2% 2/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.1% 7/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders PERIPHERAL SWELLING	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
General disorders PYREXIA	7.7% 3/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	5.9% 6/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.8% 3/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	12.2% 14/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations NASOPHARYNGITIS	7.7% 3/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.9% 8/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	14.5% 9/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	15.7% 18/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Infections and infestations SINUSITIS	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.8% 3/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.1% 7/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Injury, poisoning and procedural complications INFUSION RELATED REACTION	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.5% 4/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.6% 3/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Metabolism and nutrition disorders HYPOKALAEMIA	7.7% 3/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.7% 2/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	10.3% 4/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	14.6% 6/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	19.5% 8/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.9% 7/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.7% 6/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	21.7% 25/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.2% 2/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.8% 9/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.5% 4/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders DIZZINESS	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	5.0% 5/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.8% 9/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders HEADACHE	12.8% 5/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	14.6% 6/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	12.2% 5/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.9% 7/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	9.7% 6/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	19.1% 22/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Nervous system disorders LETHARGY	7.7% 3/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.0% 2/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.6% 1/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	1.7% 2/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Psychiatric disorders INSOMNIA	0.00% 0/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.3% 3/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.99% 1/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.2% 2/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	5.2% 6/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Psychiatric disorders SLEEP DISORDER	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.87% 1/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	10.3% 4/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.8% 3/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	6.1% 7/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	2.6% 1/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.9% 2/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	4.0% 4/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.2% 2/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	7.0% 8/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).
Skin and subcutaneous tissue disorders ALOPECIA	5.1% 2/39 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	2.4% 1/41 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.0% 3/101 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	0.00% 0/62 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).	3.5% 4/115 • Treatment-emergent AEs (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 15 weeks after the last dose of study drug (up to 67 weeks). TEAEs and TESAEs: AEs and SAEs with onset/worsening from the first dose of DB study drug until either the first dose of open-label (OL) risankizumab or 15 weeks after the last dose of DB study drug (up to 27 weeks); for All Risankizumab, from the first dose of DB or OL risankizumab until 15 weeks after the last dose of risankizumab (up to 67 weeks).

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: +1 800 243 0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER