Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients
Summary
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China. The study aims to evaluate the efficacy and safety of metformin combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis in overweight or obese Chinese patients. A total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin or secukinumab plus placebo. The study consists of a screening period, an induction period, a maintenance period, and a follow-up period, with a total duration of 60 weeks. The primary endpoints are the proportions of participants achieving PASI75 (≥75% improvement in Psoriasis Area and Severity Index) and an IGA score of 0 or 1 (clear or almost clear) at Week 24. Secondary endpoints include PASI90, quality of life (DLQI), pruritus NRS score, metabolic parameters, and safety assessments. This study aims to provide a more effective combination therapy for psoriasis patients with overweight or obesity.
Timeline
- Start
- 2026-06
- Primary completion
- 2026-06
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 2000 mg | Oral |
| Background | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |