A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509 | Recruiting Phase 2

• 1 other identifier: CIBI112C301
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response

  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).

  Week 26

Secondary Outcomes (14)

• Change from baseline in Disease Activity Score in 28 Joints (DAS28)-CRP score

  Week 26, and from baseline to Week 56

• Percentage of participants who achieved an ACR50 response

  Week 26, and from baseline to Week 56

• Percentage of participants who achieved an ACR70 response

  Week 26, and from baseline to Week 56

• Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

  Week 26, and from baseline to Week 56

• Change from baseline in Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) score

  Week 26, and from baseline to Week 56

Study Arms (3)

Picankibart Group 2

EXPERIMENTAL

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

Other: Placebo; Drug: Picankibart

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo; Drug: Picankibart

Picankibart Group 1

EXPERIMENTAL

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

Drug: Picankibart

Interventions

Placebo OTHER

Placebo administered SC at each scheduled dosing timepoint.

Picankibart Group 2; Placebo Group

Picankibart DRUG

Picankibart administered SC at each scheduled dosing timepoint.

Picankibart Group 1; Picankibart Group 2; Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
• Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
• Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
• Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
• Stable doses of protocol permitted background therapy (if any)

You may not qualify if:

• Other inflammatory conditions that may affect the evaluation of the study drug
• Prior treatment with \>2 biologic agents
• Recent use of prohibited medications (specific washout periods apply)
• Non-plaque psoriasis forms or drug-induced psoriasis
• Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
• Significant laboratory abnormalities
• Pregnancy or breastfeeding

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Bingjing Feng

CONTACT

+86 18361923769; bingjing.feng@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 19, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)