Trial Outcomes & Findings for A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (NCT NCT03706040)

NCT ID: NCT03706040

Last Updated: 2021-11-18

Results Overview

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 172 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2021-11-18

Participant Flow

Adults and adolescents with moderate to severe atopic dermatitis (AD) with onset of symptoms at least 2 years before the Baseline visit were enrolled at 50 sites in the United States, Canada, Japan, and Australia. The study included a 16-week double-blind treatment period (Period A) followed by a 36-week double-blind treatment period (Period B).

Participants were randomized in a 2:2:1 ratio to risankizumab 150 mg, 300 mg, or placebo. Randomization was stratified by disease severity (Validated Investigator Global Assessment Scale for AD [vIGA-AD] moderate vs severe) and geographic region. At Week 16 participants in the placebo group were re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg in Period B. Participants originally randomized to risankizumab remained on their previously assigned treatment.

Participant milestones

Measure	Period A: Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Period A: Risankizumab 150 mg Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Period A: Risankizumab 300 mg Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Period B: Placebo / Risankizumab 150 mg Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Placebo / Risankizumab 300 mg Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 150 mg / Risankizumab 150 mg Participants initially randomized to 150 mg risankizumab continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Period A (Week 0 to Week 16) STARTED	34	69	69	0	0	0	0
Period A (Week 0 to Week 16) Received Study Drug	34	69	69	0	0	0	0
Period A (Week 0 to Week 16) COMPLETED	25	61	58	0	0	0	0
Period A (Week 0 to Week 16) NOT COMPLETED	9	8	11	0	0	0	0
Period B (Week 16 to Week 52) STARTED	0	0	0	13	12	61	58
Period B (Week 16 to Week 52) Received Study Drug	0	0	0	13	11	61	57
Period B (Week 16 to Week 52) COMPLETED	0	0	0	5	3	33	30
Period B (Week 16 to Week 52) NOT COMPLETED	0	0	0	8	9	28	28

Reasons for withdrawal

Measure	Period A: Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Period A: Risankizumab 150 mg Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Period A: Risankizumab 300 mg Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Period B: Placebo / Risankizumab 150 mg Participants initially randomized to placebo were re-randomized at Week 16 to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Placebo / Risankizumab 300 mg Participants initially randomized to placebo were re-randomized at Week 16 to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 150 mg / Risankizumab 150 mg Participants initially randomized to 150 mg risankizumab continued to receive 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Period A (Week 0 to Week 16) Adverse Event	3	2	1	0	0	0	0
Period A (Week 0 to Week 16) Withdrew Consent	3	5	4	0	0	0	0
Period A (Week 0 to Week 16) Lost to Follow-up	1	1	4	0	0	0	0
Period A (Week 0 to Week 16) Other	2	0	2	0	0	0	0
Period B (Week 16 to Week 52) Adverse Event	0	0	0	1	2	3	0
Period B (Week 16 to Week 52) Withdrew Consent	0	0	0	3	2	1	10
Period B (Week 16 to Week 52) Lost to Follow-up	0	0	0	0	0	1	1
Period B (Week 16 to Week 52) Other	0	0	0	4	5	23	17

Baseline Characteristics

A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Total n=172 Participants Total of all reporting groups
Age, Continuous	45.5 years STANDARD_DEVIATION 19.66 • n=5 Participants	41.7 years STANDARD_DEVIATION 15.12 • n=7 Participants	43.8 years STANDARD_DEVIATION 16.63 • n=5 Participants	43.3 years STANDARD_DEVIATION 16.66 • n=4 Participants
Age, Customized < 18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Customized 18 - 39 years	15 Participants n=5 Participants	34 Participants n=7 Participants	27 Participants n=5 Participants	76 Participants n=4 Participants
Age, Customized 40 - 64 years	10 Participants n=5 Participants	27 Participants n=7 Participants	36 Participants n=5 Participants	73 Participants n=4 Participants
Age, Customized ≥ 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	31 Participants n=7 Participants	32 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	38 Participants n=7 Participants	37 Participants n=5 Participants	96 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	61 Participants n=7 Participants	63 Participants n=5 Participants	158 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/Ethnicity, Customized White	17 Participants n=5 Participants	39 Participants n=7 Participants	36 Participants n=5 Participants	92 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	49 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Geographic Region Japan	6 Participants n=5 Participants	13 Participants n=7 Participants	13 Participants n=5 Participants	32 Participants n=4 Participants
Geographic Region Rest of World	28 Participants n=5 Participants	56 Participants n=7 Participants	56 Participants n=5 Participants	140 Participants n=4 Participants
Disease Severity 3 (Moderate)	20 Participants n=5 Participants	40 Participants n=7 Participants	39 Participants n=5 Participants	99 Participants n=4 Participants
Disease Severity 4 (Severe)	14 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	73 Participants n=4 Participants
Eczema Area and Severity Index (EASI) Score	30.85 score on a scale STANDARD_DEVIATION 12.345 • n=5 Participants	31.06 score on a scale STANDARD_DEVIATION 13.995 • n=7 Participants	28.70 score on a scale STANDARD_DEVIATION 11.247 • n=5 Participants	30.07 score on a scale STANDARD_DEVIATION 12.605 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation (MI) to handle missing data due to coronavirus pandemic 2019 (COVID-19) (NRI-C) was used in the analysis.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16	11.8 percentage of participants Interval 0.9 to 22.6	24.6 percentage of participants Interval 14.5 to 34.8	21.7 percentage of participants Interval 12.0 to 31.5	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:

• 0 - Clear: No signs of AD;
• 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
• 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
• 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
• 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16	5.9 percentage of participants Interval 0.0 to 13.8	14.5 percentage of participants Interval 6.2 to 22.8	5.8 percentage of participants Interval 0.3 to 11.3	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population with a Baseline Pruritus NRS of ≥ 4; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	Placebo n=33 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=66 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=66 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	13.6 percentage of participants Interval 5.4 to 21.9	15.2 percentage of participants Interval 6.5 to 23.8	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements (MMRM). The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=51 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=43 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percent Change From Baseline in EASI Score at Week 16	-28.54 percent change Standard Error 9.378	-38.86 percent change Standard Error 5.989	-45.39 percent change Standard Error 6.351	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

EASI is used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected and the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling), scratching, and lichenification (lined skin, prurigo nodules).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease; a negative change from Baseline indicates improvement.

LS means were calculated from an analysis of covariance (ANCOVA) model with Baseline, treatment and vIGA-AD categories in the model.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percent Change From Baseline in EASI Score at Week 28 and Week 52 Week 28	-58.60 percent change Standard Error 12.091	-59.81 percent change Standard Error 14.956	-62.44 percent change Standard Error 5.065	-63.77 percent change Standard Error 5.051
Percent Change From Baseline in EASI Score at Week 28 and Week 52 Week 52	-31.39 percent change Standard Error 12.979	-76.75 percent change Standard Error 14.199	-67.47 percent change Standard Error 4.663	-62.70 percent change Standard Error 4.875

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52 Week 28	37.5 percentage of participants Interval 4.0 to 71.0	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	53.3 percentage of participants Interval 38.8 to 67.9	41.9 percentage of participants Interval 27.1 to 56.6
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	75.0 percentage of participants Interval 32.6 to 100.0	43.2 percentage of participants Interval 27.3 to 59.2	45.5 percentage of participants Interval 28.5 to 62.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved an EASI 50 Response at Week 16	29.4 percentage of participants Interval 14.1 to 44.7	42.0 percentage of participants Interval 30.4 to 53.7	34.8 percentage of participants Interval 23.5 to 46.0	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 50 response is defined as at least a 50% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52 Week 28	75.0 percentage of participants Interval 45.0 to 100.0	80.0 percentage of participants Interval 44.9 to 100.0	73.3 percentage of participants Interval 60.4 to 86.3	74.4 percentage of participants Interval 61.4 to 87.5
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52 Week 52	40.0 percentage of participants Interval 0.0 to 82.9	75.0 percentage of participants Interval 32.6 to 100.0	78.4 percentage of participants Interval 65.1 to 91.6	72.7 percentage of participants Interval 57.5 to 87.9

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved an EASI 90 Response at Week 16	2.9 percentage of participants Interval 0.0 to 8.6	14.5 percentage of participants Interval 6.2 to 22.8	8.7 percentage of participants Interval 2.0 to 15.3	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none [0], mild [1], moderate [2], or severe [3]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema).

The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

An EASI 90 response is defined as at least a 90% reduction (improvement) from Baseline in EASI score.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52 Week 28	25.0 percentage of participants Interval 0.0 to 55.0	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	26.7 percentage of participants Interval 13.7 to 39.6	27.9 percentage of participants Interval 14.5 to 41.3
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	24.3 percentage of participants Interval 10.5 to 38.1	18.2 percentage of participants Interval 5.0 to 31.3

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point

Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) was used to assess the severity of AD based on lesion appearance on the following scale:

• 0 - Clear: No signs of AD;
• 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification;
• 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting;
• 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, possible oozing or crusting;
• 4 - Severe: Marked erythema, induration/papulation and/or lichenification; possible oozing or crusting.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52 Week 28	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	22.2 percentage of participants Interval 10.1 to 34.4	25.6 percentage of participants Interval 12.5 to 38.6
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	24.3 percentage of participants Interval 10.5 to 38.1	21.2 percentage of participants Interval 7.3 to 35.2

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values.

Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=51 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=43 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16	-7.41 percentage of body surface area Standard Error 3.813	-13.64 percentage of body surface area Standard Error 2.429	-13.27 percentage of body surface area Standard Error 2.569	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point

Body surface area (BSA) affected by atopic dermatitis was assessed by the physician and is expressed as a percentage of the total BSA. For purposes of the estimation, the total surface of the participant's palm plus five digits was assumed to be approximately equivalent to 1% BSA. A negative change from Baseline indicates improvement.

LS means and standard errors were calculated from ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52 Week 52	-0.86 percentage of body surface area Standard Error 6.525	-30.23 percentage of body surface area Standard Error 7.316	-29.26 percentage of body surface area Standard Error 2.400	-22.14 percentage of body surface area Standard Error 2.510
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52 Week 28	-20.07 percentage of body surface area Standard Error 5.843	-11.90 percentage of body surface area Standard Error 7.294	-23.23 percentage of body surface area Standard Error 2.438	-23.22 percentage of body surface area Standard Error 2.443

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Intent-to-treat population; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16	18.0 percentage of participants Interval 5.0 to 31.1	24.6 percentage of participants Interval 14.5 to 34.8	13.0 percentage of participants Interval 5.1 to 21.0	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=46 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52 Week 28	44.4 percentage of participants Interval 12.0 to 76.9	20.0 percentage of participants Interval 0.0 to 55.1	47.8 percentage of participants Interval 33.4 to 62.3	37.2 percentage of participants Interval 22.8 to 51.7
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	50.0 percentage of participants Interval 1.0 to 99.0	52.6 percentage of participants Interval 36.8 to 68.5	35.1 percentage of participants Interval 19.8 to 50.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	10.1 percentage of participants Interval 3.0 to 17.3	2.9 percentage of participants Interval 0.0 to 6.9	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 75 response is defined as at least a 75% reduction (improvement) from Baseline in SCORAD score.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=46 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52 Week 28	11.1 percentage of participants Interval 0.0 to 31.6	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	23.9 percentage of participants Interval 11.6 to 36.2	11.6 percentage of participants Interval 2.0 to 21.2
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	21.1 percentage of participants Interval 8.1 to 34.0	13.5 percentage of participants Interval 2.5 to 24.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	5.8 percentage of participants Interval 0.3 to 11.3	1.4 percentage of participants Interval 0.0 to 4.3	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as a percentage of the whole body (0-100%). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 to 18. Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 to 103 (worst).

A SCORAD 90 response is defined as at least a 90% reduction (improvement) from Baseline in SCORAD score.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=46 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52 Week 28	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	6.5 percentage of participants Interval 0.0 to 13.7	4.7 percentage of participants Interval 0.0 to 10.9
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52 Week 52	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	0 percentage of participants Could not be calculated using the normal approximation to the binomial distribution	15.8 percentage of participants Interval 4.2 to 27.4	10.8 percentage of participants Interval 0.8 to 20.8

SECONDARY outcome

Timeframe: Week 16

Population: Intent-to-treat population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

Outcome measures

Measure	Placebo n=34 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=69 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=69 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16	9.0 percentage of participants Interval 0.0 to 18.8	8.7 percentage of participants Interval 2.0 to 15.3	5.8 percentage of participants Interval 0.3 to 11.3	—

SECONDARY outcome

Timeframe: Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=49 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=44 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52 Week 28	22.2 percentage of participants Interval 0.0 to 49.4	20.0 percentage of participants Interval 0.0 to 55.1	16.3 percentage of participants Interval 6.0 to 26.7	13.6 percentage of participants Interval 3.5 to 23.8
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52 Week 52	20.0 percentage of participants Interval 0.0 to 55.1	25.0 percentage of participants Interval 0.0 to 67.4	13.9 percentage of participants Interval 2.6 to 25.2	15.6 percentage of participants Interval 3.0 to 28.2

SECONDARY outcome

Timeframe: Week 16

Population: Intent-to-treat population \< 16 years old at the Baseline visit; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.

Outcome measures

Measure	Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=1 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=1 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16	—	0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 28 and 52

Population: Intent-to-treat population \< 16 years old at the Baseline visit with available data at each time point

The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A score of 0 or 1 means that the disease has no effect at all.

In this study, the CDLQI was administered to participants who were < 16 years old at Baseline.

Outcome measures

Measure	Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=1 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52 Week 28	—	—	0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population with a Baseline DLQI of ≥ 4; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used in the analysis.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.

A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).

Outcome measures

Measure	Placebo n=32 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=64 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=64 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline	25.6 percentage of participants Interval 10.3 to 41.0	31.3 percentage of participants Interval 19.9 to 42.6	37.5 percentage of participants Interval 25.6 to 49.4	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with a Baseline DLQI of ≥ 4 and with available data at each time point.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.

A change in DLQI score of at least 4 points is considered the minimum clinically important difference (MCID).

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=45 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=51 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline Week 52	60.0 percentage of participants Interval 17.1 to 100.0	50.0 percentage of participants Interval 1.0 to 99.0	63.6 percentage of participants Interval 47.2 to 80.0	66.7 percentage of participants Interval 49.8 to 83.5
Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline Week 28	77.8 percentage of participants Interval 50.6 to 100.0	40.0 percentage of participants Interval 0.0 to 82.9	66.7 percentage of participants Interval 52.9 to 80.4	68.3 percentage of participants Interval 54.0 to 82.5

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=49 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=41 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in DLQI Score at Week 16	-3.4 score on a scale Standard Error 1.55	-3.4 score on a scale Standard Error 0.95	-4.4 score on a scale Standard Error 1.03	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much).

Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.

LS means and standard errors were calculated from an ANCOVA model with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=48 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in DLQI Score at Week 28 and Week 52 Week 28	-8.0 score on a scale Standard Error 2.06	-5.3 score on a scale Standard Error 2.69	-7.1 score on a scale Standard Error 0.87	-7.3 score on a scale Standard Error 0.93
Change From Baseline in DLQI Score at Week 28 and Week 52 Week 52	-4.5 score on a scale Standard Error 2.99	-5.0 score on a scale Standard Error 3.30	-7.7 score on a scale Standard Error 1.11	-6.5 score on a scale Standard Error 1.18

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population \< 16 years old at the Baseline visit; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values.

The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.

In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.

Outcome measures

Measure	Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=1 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in CDLQI Score at Week 16	—	-2.0 score on a scale Standard Error NA Not calculated for N=1	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population \< 16 years old at the Baseline visit with available data at each time point.

The CDLQI is a 10-item, validated questionnaire used to assess the impact of AD disease symptoms and treatment on QoL. The CDLQI has been validated for use in individuals 4-16 years old. It consists of 10 questions assessing impact of skin diseases on different aspects of a patient's QoL over the prior week. The CDLQI items include symptoms and feelings, daily activities, leisure, school, relationships, sleep, and treatment. Each item is scored on a 4-point scale (0 = not at all; 1 = only a little; 2 = quite a lot; and 3 = very much). Item scores (0 to 3) are added to provide a total score range of 0 to 30; higher scores indicate greater impairment of QoL. A negative change from Baseline indicates improvement.

In this study, the CDLQI was administered to participants who were < 16 years old at the Baseline visit.

LS means were calculated from ANCOVA with Baseline and treatment in the model.

Outcome measures

Measure	Placebo Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=1 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in CDLQI Score at Week 28 and Week 52 Week 28	—	—	1.0 score on a scale Standard Error 0.00	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Intent-to-treat population; missing data were handled using a mixed-effect model with repeated measurements. The overall number of participants analyzed is based on the number of participants with non-missing Baseline and Week 16 values.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=45 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=39 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16	-0.098 score on a scale Standard Error 0.5110	-1.416 score on a scale Standard Error 0.3408	-1.746 score on a scale Standard Error 0.3619	—

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with available data at each time point.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Change from Baseline was calculated from a rolling weekly average. A negative change from Baseline indicates improvement.

LS means and standard errors were calculated from an ANCOVA with Baseline, treatment and stratum (Baseline vIGA-AD categories) in the model.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=50 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=44 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 Week 28	-2.685 score on a scale Standard Error 0.9303	-3.182 score on a scale Standard Error 1.2347	-2.474 score on a scale Standard Error 0.3887	-2.684 score on a scale Standard Error 0.4179
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 Week 52	-2.668 score on a scale Standard Error 1.2153	-4.012 score on a scale Standard Error 1.3907	-2.936 score on a scale Standard Error 0.4567	-2.454 score on a scale Standard Error 0.4957

SECONDARY outcome

Timeframe: Baseline and Weeks 28 and 52

Population: Intent-to-treat population with a Baseline Pruritus NRS of ≥ 4, and with available data at each time point.

Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive placebo by subcutaneous (SC) injection at Weeks 0 and 4 in Period A.	Risankizumab 150 mg n=5 Participants Participants randomized to receive 150 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg n=48 Participants Participants randomized to receive 300 mg risankizumab SC at Weeks 0 and 4 in Period A.	Risankizumab 300 mg / Risankizumab 300 mg n=43 Participants Participants initially randomized to 300 mg risankizumab in Period A continued to receive 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 Week 28	22.2 percentage of participants Interval 0.0 to 49.4	20.0 percentage of participants Interval 0.0 to 55.1	31.3 percentage of participants Interval 18.1 to 44.4	39.5 percentage of participants Interval 24.9 to 54.1
Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52 Week 52	20.0 percentage of participants Interval 0.0 to 55.1	25.0 percentage of participants Interval 0.0 to 67.4	38.2 percentage of participants Interval 21.9 to 54.6	28.1 percentage of participants Interval 12.5 to 43.7

Adverse Events

Period A: Placebo

Serious events: 3 serious events

Other events: 17 other events

Deaths: 1 deaths

Period A: Risankizumab 150 mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Period A: Risankizumab 300 mg

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Period B: Placebo / Risankizumab 150 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Period B: Placebo / Risankizumab 300 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Period B: Risankizumab 150 mg / Risankizumab 150 mg

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Period B: Risankizumab 300 mg / Risankizumab 300 mg

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Period A: Placebo n=34 participants at risk Participants received placebo by subcutaneous injection at Week 0 and Week 4 in Period A.	Period A: Risankizumab 150 mg n=69 participants at risk Participants received 150 mg risankizumab SC at Week 0 and Week 4 in Period A.	Period A: Risankizumab 300 mg n=69 participants at risk Participants received 300 mg risankizumab SC at Week 0 and Week 4 in Period A.	Period B: Placebo / Risankizumab 150 mg n=13 participants at risk Participants initially randomized to placebo received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Placebo / Risankizumab 300 mg n=11 participants at risk Participants initially randomized to placebo received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 150 mg / Risankizumab 150 mg n=61 participants at risk Participants initially randomized to 150 mg risankizumab in Period A received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 300 mg / Risankizumab 300 mg n=57 participants at risk Participants initially randomized to 300 mg risankizumab in Period A received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Cardiac disorders ARRHYTHMIA	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Eye disorders AMAUROSIS FUGAX	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations COVID-19	2.9% 1/34 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations CELLULITIS	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Injury, poisoning and procedural complications FRACTURED COCCYX	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA STAGE I	2.9% 1/34 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	2.9% 1/34 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.

Other adverse events

Measure	Period A: Placebo n=34 participants at risk Participants received placebo by subcutaneous injection at Week 0 and Week 4 in Period A.	Period A: Risankizumab 150 mg n=69 participants at risk Participants received 150 mg risankizumab SC at Week 0 and Week 4 in Period A.	Period A: Risankizumab 300 mg n=69 participants at risk Participants received 300 mg risankizumab SC at Week 0 and Week 4 in Period A.	Period B: Placebo / Risankizumab 150 mg n=13 participants at risk Participants initially randomized to placebo received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Placebo / Risankizumab 300 mg n=11 participants at risk Participants initially randomized to placebo received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 150 mg / Risankizumab 150 mg n=61 participants at risk Participants initially randomized to 150 mg risankizumab in Period A received 150 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.	Period B: Risankizumab 300 mg / Risankizumab 300 mg n=57 participants at risk Participants initially randomized to 300 mg risankizumab in Period A received 300 mg risankizumab SC at Week 16, Week 28, and Week 40 in Period B.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Gastrointestinal disorders DENTAL CARIES	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Gastrointestinal disorders TOOTHACHE	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	18.2% 2/11 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
General disorders OEDEMA PERIPHERAL	5.9% 2/34 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations NASOPHARYNGITIS	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	5.8% 4/69 • Number of events 6 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	5.8% 4/69 • Number of events 4 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	6.6% 4/61 • Number of events 4 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	5.3% 3/57 • Number of events 4 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations SKIN INFECTION	5.9% 2/34 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations TONSILLITIS	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations TOOTH INFECTION	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.9% 2/34 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.4% 1/69 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	4.3% 3/69 • Number of events 3 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	5.9% 2/34 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Investigations BLOOD THYROID STIMULATING HORMONE INCREASED	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Nervous system disorders DIZZINESS POSTURAL	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Reproductive system and breast disorders AMENORRHOEA	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders ACNE	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders DERMATITIS ATOPIC	20.6% 7/34 • Number of events 7 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	27.5% 19/69 • Number of events 19 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	23.2% 16/69 • Number of events 16 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	15.4% 2/13 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	11.5% 7/61 • Number of events 7 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	8.8% 5/57 • Number of events 5 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders HYPERTROPHIC SCAR	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders PRURITUS	5.9% 2/34 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	2.9% 2/69 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.2% 5/69 • Number of events 5 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	3.3% 2/61 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	2.9% 2/69 • Number of events 2 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	9.1% 1/11 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Surgical and medical procedures WISDOM TEETH REMOVAL	0.00% 0/34 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	7.7% 1/13 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/61 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/57 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.
Vascular disorders HYPERTENSION	8.8% 3/34 • Number of events 3 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/69 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	4.3% 3/69 • Number of events 3 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/13 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	0.00% 0/11 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.6% 1/61 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.	1.8% 1/57 • Number of events 1 • From first dose of study drug up to 20 weeks after last dose. Period A: 16 weeks for participants who entered Period B or up to 36 weeks for participants who did not enter Period B. Period B: From Week 16 up to Week 60.

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