Picankibart for people 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 trial tests whether subcutaneous picankibart can improve joint and skin symptoms in adults with active psoriatic arthritis who have not had enough benefit from NSAIDs or non-biologic DMARDs.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07295509 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase II/III trial with a Phase II dose-finding stage followed by a Phase III confirmatory stage. Participants receive subcutaneous picankibart (200 mg) or placebo on predefined dosing schedules, with placebo participants crossing over to active treatment at Week 26. The Phase II portion (about 90 participants) identifies the optimal dose for the Phase III portion (about 132 participants). Primary outcome is the proportion achieving an ACR20 response at Week 24, with additional measures of joint symptoms, physical function, quality of life, and skin disease.

Who should consider this trial

Good fit: Adults 18–75 years old with a diagnosis of PsA for at least 3 months who meet CASPAR criteria, have active disease with at least 3 tender and 3 swollen joints, and have active or past plaque psoriasis and inadequate response or intolerance to NSAIDs or non-biologic DMARDs are the ideal candidates.

Not a fit: Patients with other inflammatory diseases that confound assessment, prior exposure to more than two biologics, recent use of prohibited medications, non-plaque or drug-induced psoriasis, or severe uncontrolled organ/systemic conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, picankibart could reduce joint inflammation and improve physical function and skin symptoms, providing an additional treatment option for people with active PsA.

How similar studies have performed: Other biologic and targeted therapies have improved outcomes in psoriatic arthritis, but picankibart itself is still being tested in this Phase II/III program.

Eligibility criteria

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

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Bingjing Feng

Conditions Psoriatic Arthritis