A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Vanda Pharmaceuticals
- Enrollment
- 45
- Locations
- 102
- Primary Endpoint
- Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
Study Overview
Brief Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
Detailed Description
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive a single intravenous (IV) high dose imsidolimab, low dose imsidolimab, or placebo.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1
Exclusion Criteria
- •Subject has other form of psoriasis excluding psoriasis vulgaris
- •Subject flare is so severe that patient's life is at risk
Arms & Interventions
750 mg Imsidolimab
Intervention: 750 mg Imsidolimab (Drug)
300 mg Imsidolimab
Intervention: 300 mg Imsidolimab (Drug)
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Percentage of Patients Achieving a GPPPGA Score of 0 (Clear) or 1 (Almost Clear)
Time Frame: Week 4
The Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) is a physician-based assessment of the overall disease severity of GPP at the time of evaluation (specifically pustules, erythema, and scaling/crusting of pustular psoriasis lesions). The GPPPGA is graded on a 5-point scale, ranging from 0 (clear) to 4 (severe). GPPPGA Scale: 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, 4 = Severe.
Secondary Outcomes
- Percentage of Patients Achieving a PRS Score of 0 (Clear) or 1 (Almost Clear)(Week 1)