A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT ID: NCT07295509

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-19
• Study Completion Date: 2029-12-31

Brief 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

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Picankibart Group 2

Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Placebo administered SC at each scheduled dosing timepoint.

Picankibart

Intervention Type: DRUG

Picankibart administered SC at each scheduled dosing timepoint.

Placebo Group

Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo administered SC at each scheduled dosing timepoint.

Picankibart

Intervention Type: DRUG

Picankibart administered SC at each scheduled dosing timepoint.

Picankibart Group 1

Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1.

Group Type: EXPERIMENTAL

Picankibart

Intervention Type: DRUG

Picankibart administered SC at each scheduled dosing timepoint.

Interventions

Placebo

Placebo administered SC at each scheduled dosing timepoint.

Intervention Type: OTHER

Picankibart

Picankibart administered SC at each scheduled dosing timepoint.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years

2. Diagnosed with PsA for ≥6 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, with CRP ≥3 mg/L at screening

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. Prior use of TNF-α inhibitors, IL-17/23 inhibitors, or JAK inhibitors is permitted if subjects exhibited inadequate response or intolerance, with an appropriate washout period

7. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Bingjing Feng

Role: CONTACT

Phone: +86 18361923769

Email: bingjing.feng@innoventbio.com

Facility Contacts

Xiaoyong Man

Role: primary

Other Identifiers

CIBI112C301

Identifier Type: -

Identifier Source: org_study_id