Trial Outcomes & Findings for BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis (NCT NCT03000075)
NCT ID: NCT03000075
Last Updated: 2019-05-21
Results Overview
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
182 participants
Primary outcome timeframe
Week 16
Results posted on
2019-05-21
Participant Flow
A total of 182 subjects were enrolled; 11 subjects failed screening and are excluded from the analyses.
Participant milestones
| Measure |
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab 75 mg (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Placebo/Risankizumab 150 mg (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
58
|
58
|
55
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
54
|
58
|
55
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
27
|
27
|
58
|
55
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
27
|
26
|
56
|
54
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo (Part A)
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab 75 mg (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Placebo/Risankizumab 150 mg (Part B)
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Part A
Adverse Event
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Not dosed due to AE
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 12.33 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 11.94 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 11.82 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
171 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
PRIMARY outcome
Timeframe: Week 16Population: Intent-to-treat (ITT) population: all participants who were randomized.
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)
|
1.7 percentage of participants
|
75.9 percentage of participants
|
74.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
n=55 Participants
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PASI90 at Week 52 (Part B)
|
81.5 percentage of participants
|
85.2 percentage of participants
|
86.2 percentage of participants
|
92.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)
|
10.3 percentage of participants
|
86.2 percentage of participants
|
92.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
n=55 Participants
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)
|
96.3 percentage of participants
|
88.9 percentage of participants
|
84.5 percentage of participants
|
94.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)
|
8.6 percentage of participants
|
89.7 percentage of participants
|
94.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
n=55 Participants
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PASI75 at Week 52 (Part B)
|
100 percentage of participants
|
88.9 percentage of participants
|
94.8 percentage of participants
|
96.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)
|
0 percentage of participants
|
22.4 percentage of participants
|
32.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: ITT population
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=27 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=58 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
n=55 Participants
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving PASI100 at Week 52 (Part B)
|
40.7 percentage of participants
|
44.4 percentage of participants
|
43.1 percentage of participants
|
41.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: Among participants with confirmed diagnosis of PsA using classification criteria for psoriatic arthritis (CASPAR) and with baseline total tender joint count (TJC) and swollen joint count (SJC) counts ≥ 3 at selected study sites of the ITT population.
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=3 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=5 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=3 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)
|
0 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Among participants with confirmed diagnosis of PsA using CASPAR criteria and with baseline TJC and SJC counts ≥ 3 at selected study sites of the ITT population,
Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo (Part A)
n=1 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=2 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=5 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab150 mg /Risankizumab 150 mg (Part B)
n=3 Participants
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|
|
Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)
|
100 percentage of participants
|
100 percentage of participants
|
60.0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Placebo (Part A)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Risankizumab 75 mg (Part A)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Risankizumab 150 mg (Part A)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo/Risankizumab 75 mg (Part B)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo/Risankizumab 150 mg (Part B)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Risankizumab 150 mg/Risankizumab 150 mg (Part B)
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=58 participants at risk
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 participants at risk
): Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab 75 mg (Part B)
n=27 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Placebo/Risankizumab 150 mg (Part B)
n=27 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
n=56 participants at risk
Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 150 mg/Risankizumab 150 mg (Part B)
n=54 participants at risk
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pneumonia bacterial
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
Hypotension
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Placebo (Part A)
n=58 participants at risk
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 75 mg (Part A)
n=58 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Risankizumab 150 mg (Part A)
n=55 participants at risk
): Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
|
Placebo/Risankizumab 75 mg (Part B)
n=27 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Placebo/Risankizumab 150 mg (Part B)
n=27 participants at risk
Participants randomized to receive placebo in Part A switched to risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 75 mg/Risankizumab 75 mg (Part B)
n=56 participants at risk
Participants randomized to receive risankizumab 75 mg in Part A continued to receive risankizumab 75 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
Risankizumab 150 mg/Risankizumab 150 mg (Part B)
n=54 participants at risk
Participants randomized to receive risankizumab 150 mg in Part A continued to receive risankizumab 150 mg by subcutaneous (SC) injection at Weeks 16, 28, and 40 (Part B).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
4/54 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Influenza
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
2/54 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Nasopharyngitis
|
13.8%
8/58 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.2%
3/58 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
18.2%
10/55 • Number of events 11 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
29.6%
8/27 • Number of events 8 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
29.6%
8/27 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
21.4%
12/56 • Number of events 13 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
20.4%
11/54 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
Tinea pedis
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.6%
3/54 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.6%
3/54 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
Weight increased
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
5.2%
3/58 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.6%
2/55 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
11.1%
3/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/58 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.8%
1/55 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
2/27 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/58 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
7.4%
2/27 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
1.9%
1/54 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
15.5%
9/58 • Number of events 9 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.4%
2/58 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
3.7%
1/27 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/54 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 16 weeks after the last dose of study drug (up to 56 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 16 weeks after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
|
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