Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

JRCT ID: jRCT2041230033

Registered date:08/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Generalized Pustular Psoriasis
• Date of first enrollment: 22/06/2023
• Target sample size: 7
• Countries of recruitment: US,Japan,Australia,Japan,Morocco,Japan,Georgia,Japan,Germany,Japan,Korea,Japan,Malaysia,Japan,Poland,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Thailand,Japan,Tunisia,Japan,Turkey,Japan,China,Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear) at Week 4
• Secondary Outcome: Proportion of subjects achieving a PRS score of 0 (clear) or 1 (almost clear) at Week 1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both
• Include 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

Exclude criteria

- Subject has other form of psoriasis excluding psoriasis vulgaris
- Subject flare is so severe that patient's life is at risk

Related Information

• Primary Sponsor: Randazzo Bruce
• Secondary ID(s): NCT05352893,2021-001447-27