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A Study of Picankibart in Patients With Active Psoriatic Arthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT07295509•Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 18, 2025

Primary Completion Date

December 31, 2029

Completion Date

December 31, 2029

Last Updated

March 20, 2026

Enrollment

222

ESTIMATED participants

Conditions

Psoriatic Arthritis

Interventions

Placebo

OTHER

Picankibart

DRUG

Contacts

Bingjing Feng

CONTACT

+86 18361923769 bingjing.feng@innoventbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Picankibart in Patients With Active Psoriatic Arthritis

Inclusion Criteria

Exclusion Criteria

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