NCT07295509RecruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 18 Dec 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT07295509
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 222
- From 18 Dec 2025 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with \>2 biologic agents
- Recent use of prohibited medications (specific washout periods apply)
- Non-plaque psoriasis forms or drug-induced psoriasis
Other illness
- 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
Lab values
- Significant laboratory abnormalities
Other
- Pregnancy or breastfeeding
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.