A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Completed

Brief Summary: The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Detailed Description: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of risankizumab 150 mg/mL formulation in PFS in adult participants with moderate to severe plaque psoriasis. The study included a 30-day screening period, a 28-week treatment period with study visits at Weeks 0, 4, 16 and 28, and a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug. Study drug dosing consisted of 3 self-administered, subcutaneous (SC) doses on Weeks 0, 4, and 16. Dosing on Week 4 was self-administered at home.

Recruitment & Eligibility

Inclusion Criteria

Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit.
Participant meets following disease activity criteria:
Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit.
Candidate for systemic therapy as assessed by the investigator.

Exclusion Criteria

Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis.
Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
Participant has previous exposure to risankizumab.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo solution for risankizumab	Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Risankizumab	Risankizumab	Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16	At Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 16	At Week 16	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16	At Week 16	The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at Week 16) / PASI score at Baseline \* 100.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16	At Week 16	The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema, induration, and scaling of psoriatic lesions are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5.

Locations (43): Total Skin and Beauty Derm Ctr /ID# 210366
🇺🇸
Birmingham, Alabama, United States
Alliance Dermatology and MOHs /ID# 210645
🇺🇸
Phoenix, Arizona, United States
Hull Dermatology, PA /ID# 210305
🇺🇸
Rogers, Arkansas, United States
Anaheim Clinical Trials LLC /ID# 212559
🇺🇸
Anaheim, California, United States
Wallace Medical Group, Inc. /ID# 210403
🇺🇸
Beverly Hills, California, United States
Dermatology Res. Assoc., CA /ID# 210402
🇺🇸
Los Angeles, California, United States
Integrative Skin Science and Research /ID# 212551
🇺🇸
Sacramento, California, United States
Mosaic Dermatology /ID# 210780
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Santa Monica, California, United States
Skin Care Research, LLC /ID# 210514
🇺🇸
Boca Raton, Florida, United States
ACCEL Research Sites /ID# 212709
🇺🇸
DeLand, Florida, United States
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Total Skin and Beauty Derm Ctr /ID# 210366
🇺🇸Birmingham, Alabama, United States