A Study of Picankibart in Patients With Active Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Picankibart.
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Other Placebo
Placebo administered SC at each scheduled dosing timepoint. - Drug Picankibart
Picankibart administered SC at each scheduled dosing timepoint.
Primary outcome measures
- Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response [Time frame: Week 26]
Secondary outcome measures (12)
- Change from baseline in Disease Activity Score in 28 Joints (DAS28)-CRP score [Time frame: Week 26, and from baseline to Week 56]
- Percentage of participants who achieved an ACR50 response [Time frame: Week 26, and from baseline to Week 56]
- Percentage of participants who achieved an ACR70 response [Time frame: Week 26, and from baseline to Week 56]
- Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [Time frame: Week 26, and from baseline to Week 56]
- Change from baseline in Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) score [Time frame: Week 26, and from baseline to Week 56]
- Enthesitis/dactylitis resolution rates [Time frame: Week 26, and from baseline to Week 56]
- Percentage of participants who achieved 75%Psoriasis Area and Severity Index 75 response [Time frame: From baseline to Week 56]
- Change from baseline in van der Heijde-modified Total Sharp Score (vdH-mTSS) [Time frame: Week 26 and Week 56]
- Percentage of participants who experienced adverse events (AEs) [Time frame: From baseline to Week 56]
- Percentage of participants who experienced serious adverse events (SAEs) [Time frame: From baseline to Week 56]
- Maximum plasma concentration (Cmax) of picankibart [Time frame: From baseline to Week 56]
- Area under the concentration-time curve (AUC) of picankibart [Time frame: From baseline to Week 56]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Other inflammatory conditions that may affect the evaluation of the study drug
- Prior treatment with >2 biologic agents
- Recent use of prohibited medications (specific washout periods apply)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07295509 · CIBI112C301