NCT07295509

A Study of Picankibart in Patients With Active Psoriatic Arthritis

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Psoriatic Arthritis

Interventions

Type	Name	Description
OTHER	Placebo	Placebo administered SC at each scheduled dosing timepoint.
DRUG	Picankibart	Picankibart administered SC at each scheduled dosing timepoint.

Timeline

• Start date: 2025-12-18
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-12-19
• Last updated: 2026-03-20

Locations

1 site across 1 country: China