Trial Outcomes & Findings for A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (NCT NCT04435600)

NCT ID: NCT04435600

Last Updated: 2025-05-20

Results Overview

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

139 participants

Primary outcome timeframe

Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Results posted on

2025-05-20

Participant Flow

A total of 139 participants were sequentially enrolled in the trial. Two participants in Part 4 were excluded from the Intent To Treat (ITT) Population because they were not from the same age cohort as the population studied in Part 4 (children) but were added to Part 4 for administrative reasons (closure of Part 2 enrollment).

Participant milestones

Participant milestones
Measure
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab; Period B: Risankizumab
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injectionat Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 1 (Baseline to Week 40)
STARTED
12
0
0
0
0
0
0
0
0
0
Part 1 (Baseline to Week 40)
COMPLETED
12
0
0
0
0
0
0
0
0
0
Part 1 (Baseline to Week 40)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
Part 2: Period A (Baseline to Week 16)
STARTED
0
28
54
0
0
0
0
0
0
0
Part 2: Period A (Baseline to Week 16)
COMPLETED
0
28
53
0
0
0
0
0
0
0
Part 2: Period A (Baseline to Week 16)
NOT COMPLETED
0
0
1
0
0
0
0
0
0
0
Part 2: Period B (Week 16 to Week 52)
STARTED
0
0
0
28
10
22
21
0
0
0
Part 2: Period B (Week 16 to Week 52)
COMPLETED
0
0
0
28
10
22
21
0
0
0
Part 2: Period B (Week 16 to Week 52)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
Part 2: Period C (Week 52 to Week 68)
STARTED
0
0
0
0
0
0
0
8
0
0
Part 2: Period C (Week 52 to Week 68)
COMPLETED
0
0
0
0
0
0
0
8
0
0
Part 2: Period C (Week 52 to Week 68)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
Part 3 (Baseline to Week 52)
STARTED
0
0
0
0
0
0
0
0
13
0
Part 3 (Baseline to Week 52)
COMPLETED
0
0
0
0
0
0
0
0
13
0
Part 3 (Baseline to Week 52)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
Part 4 (Baseline to Week 52)
STARTED
0
0
0
0
0
0
0
0
0
32
Part 4 (Baseline to Week 52)
COMPLETED
0
0
0
0
0
0
0
0
0
29
Part 4 (Baseline to Week 52)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab; Period B: Risankizumab
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injectionat Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
Part 2 Period C: Risankizumab
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 2: Period A (Baseline to Week 16)
Lost to Follow-up
0
0
1
0
0
0
0
0
0
0
Part 4 (Baseline to Week 52)
Withdrawal by Subject
0
0
0
0
0
0
0
0
0
1
Part 4 (Baseline to Week 52)
Lost to Follow-up
0
0
0
0
0
0
0
0
0
1
Part 4 (Baseline to Week 52)
Other than specified
0
0
0
0
0
0
0
0
0
1

Baseline Characteristics

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Total
n=137 Participants
Total of all reporting groups
Age, Customized
6 to < 9 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
10 Participants
n=21 Participants
13 Participants
n=8 Participants
Age, Customized
9 to < 12 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
10 Participants
n=4 Participants
20 Participants
n=21 Participants
30 Participants
n=8 Participants
Age, Customized
12 to <15 years
5 Participants
n=5 Participants
14 Participants
n=7 Participants
22 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
41 Participants
n=8 Participants
Age, Customized
15 to <18 years
7 Participants
n=5 Participants
14 Participants
n=7 Participants
32 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
53 Participants
n=8 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
15 Participants
n=7 Participants
31 Participants
n=5 Participants
9 Participants
n=4 Participants
18 Participants
n=21 Participants
80 Participants
n=8 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
13 Participants
n=7 Participants
23 Participants
n=5 Participants
4 Participants
n=4 Participants
12 Participants
n=21 Participants
57 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
17 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=5 Participants
22 Participants
n=7 Participants
46 Participants
n=5 Participants
12 Participants
n=4 Participants
30 Participants
n=21 Participants
120 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
6 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
7 Participants
n=21 Participants
19 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
8 Participants
n=8 Participants
Race (NIH/OMB)
White
6 Participants
n=5 Participants
20 Participants
n=7 Participants
48 Participants
n=5 Participants
10 Participants
n=4 Participants
20 Participants
n=21 Participants
104 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Psoriasis Area and Severity Index (PASI) Score
21.43 score on a scale
STANDARD_DEVIATION 8.124 • n=5 Participants
16.55 score on a scale
STANDARD_DEVIATION 7.229 • n=7 Participants
16.39 score on a scale
STANDARD_DEVIATION 4.909 • n=5 Participants
26.21 score on a scale
STANDARD_DEVIATION 9.158 • n=4 Participants
18.59 score on a scale
STANDARD_DEVIATION 9.211 • n=21 Participants
18.28 score on a scale
STANDARD_DEVIATION 7.716 • n=8 Participants
Static Physician Global Assessment (sPGA) Category
0
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Static Physician Global Assessment (sPGA) Category
1
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Static Physician Global Assessment (sPGA) Category
2
0 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
11 Participants
n=8 Participants
Static Physician Global Assessment (sPGA) Category
3
0 Participants
n=5 Participants
25 Participants
n=7 Participants
42 Participants
n=5 Participants
2 Participants
n=4 Participants
23 Participants
n=21 Participants
92 Participants
n=8 Participants
Static Physician Global Assessment (sPGA) Category
4
12 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
11 Participants
n=4 Participants
4 Participants
n=21 Participants
34 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 (Defined as at Least 75% Improvement in PASI)
83.3 percentage of participants
Interval 51.6 to 97.9
85.7 percentage of participants
Interval 67.3 to 96.0
85.2 percentage of participants
Interval 72.9 to 93.4
92.3 percentage of participants
Interval 64.0 to 99.8
86.7 percentage of participants
Interval 69.3 to 96.2

PRIMARY outcome

Timeframe: At Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1)
83.3 percentage of participants
Interval 51.6 to 97.9
75.0 percentage of participants
Interval 55.1 to 89.3
79.6 percentage of participants
Interval 66.5 to 89.4
84.6 percentage of participants
Interval 54.6 to 98.1
90.0 percentage of participants
Interval 73.5 to 97.9

PRIMARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
83.3 percentage of participants
Interval 51.6 to 97.9
67.9 percentage of participants
Interval 47.6 to 84.1
68.5 percentage of participants
Interval 54.4 to 80.5
84.6 percentage of participants
Interval 54.6 to 98.1
83.3 percentage of participants
Interval 65.3 to 94.4

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
83.3 percentage of participants
Interval 51.6 to 97.9
60.7 percentage of participants
Interval 40.6 to 78.5
64.8 percentage of participants
Interval 50.6 to 77.3
84.6 percentage of participants
Interval 54.6 to 98.1
76.7 percentage of participants
Interval 57.7 to 90.1

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
41.7 percentage of participants
Interval 15.2 to 72.3
17.9 percentage of participants
Interval 6.1 to 36.9
40.7 percentage of participants
Interval 27.6 to 55.0
53.8 percentage of participants
Interval 25.1 to 80.8
43.3 percentage of participants
Interval 25.5 to 62.6

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
Baseline (Week 0)
12.5 percentage of participants
Interval 0.3 to 52.7
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (0 or 1)
Week 16
62.5 percentage of participants
Interval 24.5 to 91.5

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe) with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving sPGA of clear (score of 0) or almost clear (score of 1).

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
Baseline (Week 0)
0.0 percentage of participants
Interval 0.0 to 36.9
Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) of Clear or Almost Clear (Score of 0 or 1) and With at Least 2 Grade Improvement From Baseline
Week 16
62.5 percentage of participants
Interval 24.5 to 91.5

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in each part of the study (Parts 1-4)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=12 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=28 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
n=54 Participants
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
n=13 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=30 Participants
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
91.7 percentage of participants
Interval 61.5 to 99.8
92.9 percentage of participants
Interval 76.5 to 99.1
90.7 percentage of participants
Interval 79.7 to 96.9
100 percentage of participants
Interval 75.3 to 100.0
96.7 percentage of participants
Interval 82.8 to 99.9

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 50% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
Baseline (Week 0)
75.0 percentage of participants
Interval 34.9 to 96.8
Percentage of Participants Achieving PASI 50 (Defined as at Least 50% Improvement in PASI)
Week 16
87.5 percentage of participants
Interval 47.3 to 99.7

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 90% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
Baseline (Week 0)
37.5 percentage of participants
Interval 8.5 to 75.5
Percentage of Participants Achieving PASI 90 (Defined as at Least 90% Improvement in PASI)
Week 16
87.5 percentage of participants
Interval 47.3 to 99.7

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 100% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
Baseline (Week 0)
0 percentage of participants
Interval 0.0 to 36.9
Percentage of Participants Achieving PASI 100 (Defined as at Least 100% Improvement in PASI)
Week 16
25.0 percentage of participants
Interval 3.2 to 65.1

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvement in PASI.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=8 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
Baseline (Week 0)
37.5 percentage of participants
Interval 8.5 to 75.5
Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI)
Week 16
87.5 percentage of participants
Interval 47.3 to 99.7

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.

The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=27 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=49 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
-6.8 score on a scale
Standard Error 0.66
-7.4 score on a scale
Standard Error 0.49

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The CDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on quality of life (QOL). The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item was scored on a 4-point scale: 0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=6 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
-7.5 score on a scale
Standard Error 2.88

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.

The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=24 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=48 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
-6.0 score on a scale
Standard Error 0.84
-6.9 score on a scale
Standard Error 0.60

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The FDLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of dermatologic disease symptoms and treatment on Quality of Life (QOL) of family members. It consists of 10 questions that assess the impact of skin diseases on different aspects of the family member's QOL. Each item was scored on a 4-point scale: 0 = not at all; 1 = a little; 2 = quite a lot; and 3 = very much. Item scores (0 to 3) were added to provide a total score range of 0 to 30 with higher scores representing greater impairment of QOL and worse outcomes. A negative change from baseline score indicated a reduced impairment of QOL.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=6 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Family Dermatology Life Quality Index (FDLQI) Total Score
-5.8 score on a scale
Standard Error 3.29

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.

The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=27 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=45 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
-2.9 score on a scale
Standard Error 0.50
-3.8 score on a scale
Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of the re-treatment phase in Part 2 (Period C)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period C only.

The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. A negative change from baseline indicates less intense itching and better outcomes.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=6 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Change From Baseline in Itch Numerical Rating Scale (Itch NRS)
-2.8 score on a scale
Standard Error 1.68

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 16 of initial treatment in Part 2 (Period A)

Population: The Intent to Treat (ITT) Population included all enrolled participants from Parts 1, 3, and 4, and all randomized participants from Part 2. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure in Part 2 Period A only.

The itch NRS is an 11-point scale that participants complete to describe the intensity of their itch within a 24-hour recall period. The itch NRS scale scores varies between 0, representing "no itching" and 10, representing "worst itch imaginable" with higher scores representing worse outcomes. Data are reported for the percentage of participants achieving \>= 4 point improvement in the itch NRS in participants with a baseline itch NRS score of \>=4.

Outcome measures

Outcome measures
Measure
Part 1: Risankizumab
n=14 Participants
Participants received open-label risankizumab by subcutaneous injection at weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Ustekinumab
n=37 Participants
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Risankizumab
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 3: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Percentage of Participants Achieving >= 4-point Improvement in the Itch Numerical Rating Scale (in Participants With Baseline Score >= 4)
57.1 percentage of participants
Interval 28.9 to 82.3
64.9 percentage of participants
Interval 47.5 to 79.8

Adverse Events

Part 1: Risankizumab

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part 2 Period A: Risankizumab

Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths

Part 2 Period A: Ustekinumab

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Part 2 Period A: Ustekinumab; Period B: Risankizumab

Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths

Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Part 2 Period A Risankizumab Responders; Period B: Risankizumab

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal

Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths

Part 2 Period C: Risankizumab

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 3: Risankizumab

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part 4: Risankizumab

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Part 1: Risankizumab
n=12 participants at risk
Participants received open-label risankizumab by subcutaneous injection on weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Risankizumab
n=54 participants at risk
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab
n=28 participants at risk
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab; Period B: Risankizumab
n=28 participants at risk
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
n=10 participants at risk
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
n=22 participants at risk
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
n=21 participants at risk
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
Part 2 Period C: Risankizumab
n=8 participants at risk
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Part 3: Risankizumab
n=13 participants at risk
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=32 participants at risk
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Gastrointestinal disorders
EOSINOPHILIC OESOPHAGITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
FIBULA FRACTURE
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Psychiatric disorders
SUICIDAL IDEATION
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure
Part 1: Risankizumab
n=12 participants at risk
Participants received open-label risankizumab by subcutaneous injection on weeks 0, 4, 16, 28, and 40.
Part 2 Period A: Risankizumab
n=54 participants at risk
Participants received risankizumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab
n=28 participants at risk
Participants received ustekinumab by subcutaneous injection at Weeks 0 and 4.
Part 2 Period A: Ustekinumab; Period B: Risankizumab
n=28 participants at risk
Participants who received ustekinumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Non-responders; Period B: Risankizumab
n=10 participants at risk
Participants who did not respond to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Risankizumab
n=22 participants at risk
Participants who responded to risankizumab in Part 2 Period A received risankizumab by subcutaneous injection at Weeks 16, 28, and 40.
Part 2 Period A Risankizumab Responders; Period B: Treatment Withdrawal
n=21 participants at risk
Participants who responded to risankizumab in Part 2 Period A received no treatment in Part 2 Period B.
Part 2 Period C: Risankizumab
n=8 participants at risk
Participants randomized to the treatment withdrawal arm in Part 2 Period B who experienced a disease flare on or after Week 28 received risankizumab by subcutaneous injection at Weeks 0 and 4 of the 16-week re-treatment period.
Part 3: Risankizumab
n=13 participants at risk
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Part 4: Risankizumab
n=32 participants at risk
Participants received open-label risankizumab by subcutaneous injection at Weeks 0, 4, 16, 28, and 40.
Gastrointestinal disorders
ABDOMINAL PAIN
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders
CONSTIPATION
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders
NAUSEA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
General disorders
CHILLS
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
General disorders
INJECTION SITE HAEMATOMA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
General disorders
PAIN
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
General disorders
PYREXIA
16.7%
2/12 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
25.0%
2/8 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
12.5%
4/32 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Hepatobiliary disorders
HYPERTRANSAMINASAEMIA
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
BACTERIAL VAGINOSIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
BODY TINEA
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
BRONCHITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
CONJUNCTIVITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
COVID-19
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.3%
5/54 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.1%
2/28 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
20.0%
2/10 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
GASTROENTERITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.4%
3/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
GASTROENTERITIS VIRAL
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
INFLUENZA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
LICE INFESTATION
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
NASOPHARYNGITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
18.5%
10/54 • Number of events 17 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
14.3%
4/28 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
42.9%
12/28 • Number of events 20 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
40.0%
4/10 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
22.7%
5/22 • Number of events 9 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
31.2%
10/32 • Number of events 16 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
OTITIS MEDIA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
PARONYCHIA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
RHINITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
SKIN CANDIDA
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
TINEA VERSICOLOUR
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
TONSILLITIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations
URINARY TRACT INFECTION
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications
SKIN INJURY
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Investigations
ALANINE AMINOTRANSFERASE INCREASED
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.7%
3/28 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Investigations
BLOOD POTASSIUM INCREASED
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
8.3%
1/12 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
13.6%
3/22 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Nervous system disorders
HEADACHE
16.7%
2/12 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
5.6%
3/54 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.7%
3/28 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.7%
3/28 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
18.2%
4/22 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Renal and urinary disorders
URINARY INCONTINENCE
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders
DYSMENORRHOEA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
COUGH
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.7%
3/28 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
9.4%
3/32 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
1.9%
1/54 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
14.3%
3/21 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
ECZEMA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
POST INFLAMMATORY PIGMENTATION CHANGE
8.3%
1/12 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.6%
1/28 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
PRURITUS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
10.0%
1/10 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/21 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/32 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
PSORIASIS
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
12.5%
1/8 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
3.1%
1/32 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders
URTICARIA
0.00%
0/12 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/54 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/28 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/10 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/22 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/8 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
0.00%
0/13 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
6.2%
2/32 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection (Day 1) to the end of the study follow-up. The median time on follow-up was 385.5, 132.5, 130.5, 255.5, 252.0, 256.5, 250.0, 119.5, 385.0, and 386.0 days for arms Part 1: Risankizumab (Risa), Part 2 Period A (P2PA): Risa, P2PA: Ustekinumab (Uste), P2PB: Uste/Risa, P2PB Non-responders/Risa, P2PB Responders/Risa, P2PB Treatment Withdrawal, P2PC: Risa, P3: Risa, and P4: Risa respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.

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