A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study ID
NCT06945107
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Picankibart — DRUG
    The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32. The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.
  • Secukinumab — DRUG
    The participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12.
  • Placebo — DRUG
    The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36. The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.
  • Ixekizumab — DRUG
    The participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12.

Study Details

This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.

Key Dates

Start date
May 27, 2025
Status verified
Mar 2026
Primary completion
Jun 7, 2026
Completion
Jan 19, 2027

Study Design

Enrollment
308 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Picankibart treatment group
    The participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.
  • Active Comparator: IL-17 mAb continued treatment group
    The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36.

Primary Outcome Measure

The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) [ Time Frame: Week 16 ]

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