A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis

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 Overview

• Status: Recruiting
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Other: Placebo; Drug: Picankibart

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Bingjing Feng; Phone Number: +86 18361923769; Email: bingjing.feng@innoventbio.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Xiaoyong Man; Phone Number: +86 57187783753; Email: manxy@zju.edu.cn
      • Principal Investigator: Xiaoyong Man, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years
2. Diagnosed with PsA for ≥3 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
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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Picankibart Group 2; Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2.	Other: Placebo; Placebo administered SC at each scheduled dosing timepoint.; Drug: Picankibart; Picankibart administered SC at each scheduled dosing timepoint.
Placebo Comparator: Placebo Group; Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26.	Other: Placebo; Placebo administered SC at each scheduled dosing timepoint.; Drug: Picankibart; Picankibart administered SC at each scheduled dosing timepoint.
Experimental: Picankibart Group 1; Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1.	Drug: Picankibart; Picankibart administered SC at each scheduled dosing timepoint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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.	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.	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).	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.	From baseline to Week 56
Change from baseline in van der Heijde-modified Total Sharp Score (vdH-mTSS)	The vdH-mTSS is a measure of change in joint health. X-rays of hands and feet are obtained at screening, Week 26 and Week 56. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the vdH-mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in vdH-mTSS from baseline represents disease progression and/or joint worsening.	Week 26 and Week 56
Percentage of participants who experienced adverse events (AEs)	An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.	From baseline to Week 56
Percentage of participants who experienced serious adverse events (SAEs)	An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.	From baseline to Week 56
Maximum plasma concentration (Cmax) of picankibart	Plasma concentration of picankibart is evaluated at each scheduled dosing timepoint. Cmax is the highest concentration of a drug in the blood.	From baseline to Week 56
Area under the concentration-time curve (AUC) of picankibart	Plasma concentration of picankibart is evaluated at each scheduled dosing timepoint. AUC represents the area under the concentration-time curve and gives insight into the extent of exposure to a drug and its clearance rate from the body.	From baseline to Week 56
Percentage of participants who developed anti-drug antibody (ADA)	ADAs are immune system-produced antibodies that specifically bind to therapeutic drugs, potentially altering their pharmacokinetics, efficacy, or safety.	From baseline to Week 56
Percentage of participants who developed neutralizing antibody (NAb)	NAbs are ADAs that inhibit the drug's biological function by blocking target interaction.	From baseline to Week 56

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic
• Other Study ID Numbers: CIBI112C301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No