A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-03-20

No results posted yet for this 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.

Conditions

Interventions

OTHER

Placebo

Placebo administered SC at each scheduled dosing timepoint.

DRUG

Picankibart

Picankibart administered SC at each scheduled dosing timepoint.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295509 on ClinicalTrials.gov