A Study of Picankibart in Patients With Active Psoriatic Arthritis

Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study ID
NCT07295509
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — OTHER
    Placebo administered SC at each scheduled dosing timepoint.
  • Picankibart — DRUG
    Picankibart administered SC at each scheduled dosing timepoint.

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Dec 18, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Picankibart Group 2
    Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2.
  • Placebo Comparator: Placebo Group
    Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26.
  • Experimental: Picankibart Group 1
    Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1.

Primary Outcome Measure

Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response [ Time Frame: Week 26 ]

Central Contacts

Find similar trials

Nationwide
Psoriatic arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

Related Studies