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A Study of Picankibart in Patients With Active Psoriatic Arthritis

StatusRecruiting
PhasePhase 2/3
Started2025-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-03-18
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-19→confirmed 2025-12-18
Eligibility criteria-207 characters
Inclusion Criteria: Age 18-75 years Diagnosed with PsA for ≥63 months, and meeting Classification Criteria for Psoriatic A [...] ender joints and ≥3 swollen joints at screening and baseline, with CRP ≥3 mg/L at screening Having active plaque psoriasis (≥1 lesion ≥2cm) or nail pso [...] ponse or intolerance to prior NSAIDs or non-biologic DMARDs Prior use of TNF-α inhibitors, IL-17/23 inhibitors, or JAK inhibitors is permitted if subjects exhibited inadequate response or intolerance, with an appropriate washout period Stable doses of protocol permitted background therapy (if an [...]
Study sitesdetails revised at 1 of 1 site
2025-12-16
Original filing
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.
Trial Details
NCT Number NCT07295509
Lead Sponsor Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Conditions Psoriatic Arthritis
Enrollment 222 participants
Start Date 2025-12-18
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-20