Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients

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.

NCT Number	NCT07485764
Lead Sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions	Psoriasis, Plaque Psoriasis, Moderate-to-severe Plaque Psoriasis, Overweight , Obesity
Enrollment	186 participants
Start Date	2026-06
Primary Completion	2026-06 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-25