A Study of Picankibart in Patients With Active Psoriatic Arthritis
NCT07295509 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 222
Last updated 2026-03-20
Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.
Conditions
Interventions
- OTHER
-
Placebo
Placebo administered SC at each scheduled dosing timepoint.
- DRUG
-
Picankibart
Picankibart administered SC at each scheduled dosing timepoint.
Sponsors & Collaborators
-
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-18
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
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