Tests picankibart against placebo in adults with active psoriatic arthritis
Tests picankibart, or placebo, in adults with active psoriatic arthritis.
Plain-language title generated from the registry record
Registry title: A Study of Picankibart in Patients With Active Psoriatic Arthritis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07295509, who can take part
Where in China
- The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Trial code
- NCT07295509
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 18-75 years; Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening; Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline; Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis; Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs; Stable doses of protocol permitted background therapy (if any).
Exclusion: Prior treatment with >2 biologic agents; Recent use of prohibited medications (specific washout periods apply); Non-plaque psoriasis forms or drug-induced psoriasis; Other inflammatory conditions that may affect the evaluation of the study drug; 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.