Actively Recruiting
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
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2026-03-20
222
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of picankibart (IBI112) in adults with active psoriatic arthritis (PsA) through a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial. The study aims to identify the optimal dose in Phase II and confirm effectiveness in Phase III by measuring improvements in joint symptoms, physical function, quality of life, and skin manifestations. The primary goal is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 response at Week 24. Participants will be randomly assigned to receive subcutaneous injections of picankibart or placebo at scheduled times. The Phase II stage includes dose-finding with 90 participants, while the Phase III stage involves 132 participants to confirm dosing and efficacy. Placebo recipients will switch to active picankibart treatment at Week 26. Different dosing schedules are used, and the study evaluates both short- and longer-term responses. During the trial, participants will undergo regular assessments including joint evaluations, physical function questionnaires, quality of life surveys, and skin evaluations. Safety will be monitored through adverse event tracking and laboratory tests up to Week 56. Pharmacokinetic and immunogenicity measures such as plasma concentration and antibody development will also be collected. Overall participation may last up to 56 weeks, with ongoing monitoring of disease activity and treatment effects.
CONDITIONS
Brief Title
A Study of Picankibart in Patients With Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with psoriatic arthritis for 3 months or more and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- Active psoriatic arthritis with 3 or more tender joints and 3 or more swollen joints at screening and baseline
- Presence of 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 allowed background therapy (if any)
You will not qualify if you...
- Other inflammatory conditions affecting study drug evaluation
- Prior treatment with more than 2 biologic agents
- Recent use of prohibited medications with required washout periods
- Non-plaque psoriasis forms or drug-induced psoriasis
- Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
- Significant laboratory abnormalities
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 26 weeks
Participants receive picankibart or placebo by subcutaneous injection at scheduled dosing timepoints.
Visits occur according to dosing schedule up to Week 26
Duration - From Week 26 to Week 56
Participants are monitored for efficacy and safety outcomes following treatment.
Regular follow-up visits until Week 56
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
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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