A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- Risankizumab
- Conditions
- Psoriasis
- Sponsor
- AbbVie
- Enrollment
- 157
- Locations
- 43
- Primary Endpoint
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Risankizumab
Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
Intervention: Risankizumab
Placebo
Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16
Intervention: Placebo solution for risankizumab
Outcomes
Primary Outcomes
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16
Time Frame: 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
Time Frame: 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 Outcomes
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 100 at Week 16(At Week 16)
- Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear at Week 16(At Week 16)