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

NCT07485764 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Secukinumab 300mg s.c.

Secukinumab 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.

DRUG

Metformin

Oral 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.

DRUG

Placebo

Placebo tablets matching metformin in appearance, administered orally following the same titration schedule.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Juan Tao, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07485764 on ClinicalTrials.gov