A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509 · tracked via the Priya Life Science China tracker

Sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD

Phase

Phase 2/3

Started

2025-12-18

Last updated

2026-03-20

Condition(s) studied

Psoriatic Arthritis

Investigational drug(s) / intervention(s)

PlaceboPicankibart →

Placebo: Placebo administered SC at each scheduled dosing timepoint.

Picankibart: Picankibart administered SC at each scheduled dosing timepoint.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response — Week 26
The ACR20 response is defined as ≥20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥20% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm= very well to 100 mm= very poor\]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), \[0 = no arthritis to 100 = extremely active arthritis\], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	Recruiting

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Other trials for the same condition

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs Active, not recruiting

Real-World Study of Xeligekimab for Moderate to Severe Plaque Psoriasis(XP-Real) Starting soon

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis Recruiting

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines Active, not recruiting

A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07295509 on ClinicalTrials.gov ↗ ← All trials in China