A Study of Picankibart in Patients With Active Psoriatic Arthritis

Phase 3Not Yet RecruitingNCT07295509

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

222

Conditions

Psoriatic Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Week 26

Secondary Outcomes

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

The DAS28-CRP is a measure of disease activity based on swollen and tender joint counts in 28 joints, CRP and the participant's global assessment of disease activity. The range of DAS28-CRP score is 0-10. Higher score means more disease activity.

Time frame: Week 26, and from baseline to Week 56

Percentage of participants who achieved an ACR50 response

The ACR50 response is defined as ≥50% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥50% 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).

Time frame: Week 26, and from baseline to Week 56

Percentage of participants who achieved an ACR70 response

The ACR70 response is defined as ≥70% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥70% 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).

Time frame: Week 26, and from baseline to Week 56

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

HAQ-DI measures improvement in physical function/disability. It is 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.

Time frame: Week 26, and from baseline to Week 56

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

The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100) and a positive change from Baseline indicates improvement.

Time frame: Week 26, and from baseline to Week 56

Enthesitis/dactylitis resolution rates

Percentage of participants with complete resolution of enthesitis (inflammation at tendon/ligament attachments) or dactylitis (sausage-digit swelling).

Time frame: Week 26, and from baseline to Week 56

Percentage of participants who achieved 75%Psoriasis Area and Severity Index 75 response

Percentage of participants who achieve at least 75% or 90% or 100% reduction in Psoriasis Area and Severity Index (PASI) score, assessing skin lesion severity in psoriatic arthritis patients.