A Study of Picankibart in Patients With Active Psoriatic Arthritis

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: Picankibart; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07295509

CIBI112C301

Details and patient eligibility

About

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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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222 participants in 3 patient groups, including a placebo group

Picankibart Group 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: Picankibart

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Drug: Picankibart

Picankibart Group 1

Experimental group

Description:

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

Treatment:

Drug: Picankibart