RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18-75 years 2. Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening 3. Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline 4. Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis 5. Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs 6. Stable doses of protocol permitted background therapy (if any) Who Should NOT Join This Trial: 1. Other inflammatory conditions that may affect the evaluation of the study drug 2. Prior treatment with \>2 biologic agents 3. Recent use of prohibited medications (specific waiting period after previous treatments apply) 4. Non-plaque psoriasis forms or drug-induced psoriasis 5. Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions 6. Significant laboratory abnormalities 7. Pregnancy or breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 18-75 years 2. Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening 3. Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline 4. Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis 5. Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs 6. Stable doses of protocol permitted background therapy (if any) Exclusion Criteria: 1. Other inflammatory conditions that may affect the evaluation of the study drug 2. Prior treatment with \>2 biologic agents 3. Recent use of prohibited medications (specific washout periods apply) 4. Non-plaque psoriasis forms or drug-induced psoriasis 5. Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions 6. Significant laboratory abnormalities 7. Pregnancy or breastfeeding

Treatments Being Tested

OTHER

Placebo

Placebo administered SC at each scheduled dosing timepoint.

DRUG

Picankibart

Picankibart administered SC at each scheduled dosing timepoint.

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China