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A Study of Picankibart in Patients With Active Psoriatic Arthritis
Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
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.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2025-12-18
Completion Date
2029-12-31
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Placebo
Placebo administered SC at each scheduled dosing timepoint.
Picankibart
Picankibart administered SC at each scheduled dosing timepoint.
Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China