Picankibart for people with active psoriatic arthritis
Official title: 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
Run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · NCT07295509 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 222 (estimated) |
| Sponsor | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT07295509 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other biologic and targeted therapies have improved outcomes in psoriatic arthritis, but picankibart itself is still being tested in this Phase II/III program.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Bingjing Feng
- Email: bingjing.feng@innoventbio.com
- Phone: +86 18361923769
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.