Actively Recruiting
A Study of Picankibart in Patients With Active Psoriatic Arthritis
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2026-03-20
222
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Picankibart in Patients With Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years
- Diagnosed with psoriatic arthritis for at least 3 months and meeting CASPAR criteria
- Active psoriatic arthritis with at least 3 tender joints and 3 swollen joints at screening and baseline
- Active plaque psoriasis (at least 1 lesion 2 cm or larger), nail psoriasis, or documented history of plaque psoriasis
- Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
- Stable doses of permitted background therapy, if any
You will not qualify if you...
- Other inflammatory conditions that could affect study drug evaluation
- Prior treatment with more than 2 biologic agents
- Recent use of prohibited medications with specific required washout periods
- Non-plaque psoriasis types or drug-induced psoriasis
- Severe, progressive, or uncontrolled major organ or systemic conditions including renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, psychiatric, or genitourinary diseases (excluding psoriatic arthritis)
- Significant laboratory abnormalities
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
B
Bingjing Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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