Trial Outcomes & Findings for A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (NCT NCT03926169)
NCT ID: NCT03926169
Last Updated: 2022-08-11
Results Overview
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
Baseline (Week 0), Week 16
Results posted on
2022-08-11
Participant Flow
In Period A, participants who met the study's eligibility criteria were randomized at the Baseline Visit, in a 1:1:1 ratio, to receive either placebo, risankizumab 180 mg or 360 mg via a subcutaneous (SC) injection.
Participant milestones
| Measure |
Placebo / Risankizumab 360 mg
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 180 mg / Risankizumab 360 mg
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 360 mg / Risankizumab 360 mg
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
|---|---|---|---|
|
Period A
STARTED
|
82
|
80
|
81
|
|
Period A
Never Received Study Drug
|
0
|
0
|
1
|
|
Period A
COMPLETED
|
74
|
70
|
75
|
|
Period A
NOT COMPLETED
|
8
|
10
|
6
|
|
Period B
STARTED
|
74
|
70
|
75
|
|
Period B
Entered Period B and Received Study Drug
|
74
|
70
|
74
|
|
Period B
COMPLETED
|
4
|
7
|
4
|
|
Period B
NOT COMPLETED
|
70
|
63
|
71
|
Reasons for withdrawal
| Measure |
Placebo / Risankizumab 360 mg
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 180 mg / Risankizumab 360 mg
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 360 mg / Risankizumab 360 mg
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
|---|---|---|---|
|
Period A
Adverse Event
|
2
|
2
|
1
|
|
Period A
Withdrawal by Subject
|
2
|
2
|
2
|
|
Period A
Lost to Follow-up
|
3
|
1
|
0
|
|
Period A
Lack of Efficacy
|
0
|
2
|
2
|
|
Period A
COVID-19 Infection
|
0
|
1
|
0
|
|
Period A
COVID-19 Logistical Restrictions
|
0
|
2
|
1
|
|
Period A
Other, Not Specified
|
1
|
0
|
0
|
|
Period B
Adverse Event
|
3
|
1
|
1
|
|
Period B
Withdrawal by Subject
|
1
|
3
|
0
|
|
Period B
Lack of Efficacy
|
3
|
1
|
1
|
|
Period B
Lost to Follow-up
|
1
|
1
|
4
|
|
Period B
Other, Not Specified
|
62
|
57
|
65
|
Baseline Characteristics
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Placebo / Risankizumab 360 mg
n=82 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 180 mg / Risankizumab 360 mg
n=80 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 360 mg / Risankizumab 360 mg
n=81 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
38.9 years
STANDARD_DEVIATION 11.45 • n=7 Participants
|
38.2 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 11.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Abscess and Inflammatory Nodule (AN) Count
|
15.7 abscess and inflammatory nodules
STANDARD_DEVIATION 28.42 • n=5 Participants
|
13.7 abscess and inflammatory nodules
STANDARD_DEVIATION 11.42 • n=7 Participants
|
12.5 abscess and inflammatory nodules
STANDARD_DEVIATION 8.24 • n=5 Participants
|
14.0 abscess and inflammatory nodules
STANDARD_DEVIATION 18.36 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 16Population: Intent-to-Treat Population: all randomized participants. Non-responder imputation with multiple imputation to handle missing data due to COVID-19 (NRI-C) .
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
Outcome measures
| Measure |
Placebo
n=82 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=80 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=81 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
|
41.5 percentage of participants
Interval 29.3 to 53.7
|
46.8 percentage of participants
Interval 34.2 to 59.4
|
43.4 percentage of participants
Interval 31.0 to 55.8
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 8Population: Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Outcome measures
| Measure |
Placebo
n=61 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=61 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=60 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
|
33.0 percentage of participants
Interval 19.4 to 46.5
|
29.2 percentage of participants
Interval 15.9 to 42.6
|
40.0 percentage of participants
Interval 25.8 to 54.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation with multiple imputation to handle missing data due to COVID-19.
NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.
Outcome measures
| Measure |
Placebo
n=61 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=61 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=60 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
|
27.9 percentage of participants
Interval 15.0 to 40.7
|
31.1 percentage of participants
Interval 17.5 to 44.7
|
38.6 percentage of participants
Interval 24.4 to 52.7
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with Baseline NRS ≥ 3. Non-responder imputation.
Outcome measures
| Measure |
Placebo
n=82 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=80 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=81 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
|
29.3 percentage of participants
Interval 18.0 to 40.5
|
22.5 percentage of participants
Interval 12.0 to 33.0
|
18.5 percentage of participants
Interval 8.8 to 28.2
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.
The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
Outcome measures
| Measure |
Placebo
n=62 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=66 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=63 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
|
-2.1 score on a scale
Interval -3.9 to -0.4
|
-3.5 score on a scale
Interval -5.2 to -1.8
|
-3.7 score on a scale
Interval -5.5 to -2.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.
HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Outcome measures
| Measure |
Placebo
n=65 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=53 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=63 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
|
-0.870 score on a scale
Interval -1.416 to -0.324
|
-0.751 score on a scale
Interval -1.338 to -0.165
|
-0.885 score on a scale
Interval -1.436 to -0.334
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Outcome measures
| Measure |
Placebo
n=65 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=53 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=63 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
|
-0.677 score on a scale
Interval -1.16 to -0.195
|
-0.635 score on a scale
Interval -1.149 to -0.12
|
-0.442 score on a scale
Interval -0.928 to 0.044
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 16Population: Intent-to-Treat Population: all randomized participants. Participants with an assessment at given time point.
HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
Outcome measures
| Measure |
Placebo
n=65 Participants
In Period A, participants received blinded placebo via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=53 Participants
In Period A, participants received blinded risankizumab 180 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=63 Participants
In Period A, participants received blinded risankizumab 360 mg via SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
|---|---|---|---|
|
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
|
-0.630 score on a scale
Interval -1.154 to -0.107
|
-0.882 score on a scale
Interval -1.44 to -0.324
|
-0.705 score on a scale
Interval -1.233 to -0.176
|
Adverse Events
Risankizumab 180 mg / Risankizumab 360 mg
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Risankizumab 360 mg / Risankizumab 360 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Risankizumab 180 mg
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Risankizumab 360 mg
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo / Risankizumab 360 mg
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Risankizumab 180 mg / Risankizumab 360 mg
n=70 participants at risk
In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 360 mg / Risankizumab 360 mg
n=74 participants at risk
In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Placebo
n=82 participants at risk
In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=80 participants at risk
In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=80 participants at risk
In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Placebo / Risankizumab 360 mg
n=74 participants at risk
In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/82 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
TONSILLITIS
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Psychiatric disorders
INTENTIONAL SELF-INJURY
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/82 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
Other adverse events
| Measure |
Risankizumab 180 mg / Risankizumab 360 mg
n=70 participants at risk
In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Risankizumab 360 mg / Risankizumab 360 mg
n=74 participants at risk
In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
|
Placebo
n=82 participants at risk
In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 180 mg
n=80 participants at risk
In Period A, participants received blinded risankizumab 180 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Risankizumab 360 mg
n=80 participants at risk
In Period A, participants received blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
|
Placebo / Risankizumab 360 mg
n=74 participants at risk
In Period A, participants received blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
In Period B, participants received blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants received open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.7%
2/74 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
4.9%
4/82 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.5%
2/80 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.5%
2/80 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
6.8%
5/74 • Number of events 5 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.7%
4/70 • Number of events 5 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
3.7%
3/82 • Number of events 3 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
7.5%
6/80 • Number of events 6 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
8.8%
7/80 • Number of events 8 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/82 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/80 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.0%
4/80 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.7%
2/74 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/74 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.2%
1/82 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.0%
4/80 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
3.8%
3/80 • Number of events 3 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.4%
4/74 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.4%
2/82 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
3.8%
3/80 • Number of events 3 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.0%
4/80 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.7%
2/74 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Nervous system disorders
HEADACHE
|
1.4%
1/70 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.4%
4/74 • Number of events 5 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
11.0%
9/82 • Number of events 16 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
7.5%
6/80 • Number of events 6 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
13.8%
11/80 • Number of events 15 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
9.5%
7/74 • Number of events 10 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/70 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
5.4%
4/74 • Number of events 4 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/82 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
0.00%
0/80 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.5%
2/80 • Number of events 2 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
1.4%
1/74 • Number of events 1 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS
|
11.4%
8/70 • Number of events 8 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
13.5%
10/74 • Number of events 10 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
8.5%
7/82 • Number of events 7 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
3.8%
3/80 • Number of events 3 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
2.5%
2/80 • Number of events 3 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
8.1%
6/74 • Number of events 6 • From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER