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.
Subjects voluntarily participate in the study and sign the informed consent form.
Aged 18-75 years (inclusive) at the time of signing informed consent, male or female.
Diagnosed with chronic plaque psoriasis for >=6 months prior to the first study drug administration.
Overweight/obesity: Body mass index (BMI) >=25 kg/m².
1: BMI <25 kg/m². 2: Presence of guttate, pustular, or erythrodermic psoriasis, or other diseases that may confound treatment outcomes (e.g., cutaneous lesions, systemic autoimmune diseases).
Parallel
Secukinumab 300mg s.c.
DrugSecukinumab is a fully human monoclonal antibody that selectively targets interleukin-17A (IL-17A), a key cytokine involved in the pathogenesis of psoriasis. In this study, secukinumab is administered as a subcutaneous injection at a dose of 300 mg. The dosing schedule includes weekly injections during the induction period (Weeks 0, 1, 2, 3, and 4), followed by maintenance dosing every 4 weeks thereafter. It is used in both the experimental and control arms.
Metformin
DrugOral biguanide medication. Starting dose: 500 mg/day, titrated weekly by 500 mg to a maximum of 2000 mg/day (or maximum tolerated dose, e.g., 1500 mg/day), then maintained.
Placebo
DrugPlacebo tablets matching metformin in appearance, administered orally following the same titration schedule.
Proportion of Participants Achieving PASI75 at Week 24
Percentage of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline to Week 24.
Proportion of Participants Achieving IGA Score of 0 or 1 at Week 24
Percentage of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 24.
Proportion of Participants Achieving PASI90 at Week 24
Percentage of participants achieving at least 90% improvement in PASI score from baseline to Week 24
Proportion of Participants Achieving PASI75/90/100 at Week 52
Percentage of participants achieving PASI75, PASI90, or PASI100 at Week 52.
Proportion of Participants Achieving IGA 0/1 at Week 52
Percentage of participants achieving IGA score of 0 or 1 at Week 52.
Change in DLQI Score at Week 24
Mean change in Dermatology Life Quality Index (DLQI) score from baseline to Week 24.The DLQI is a 10-item questionnaire with scores ranging from 0 (no impairment) to 30 (maximum impairment), where higher scores indicate worse quality of life and greater disease burden.
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