Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obes… (NCT07485764) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients
China186 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Deemed candidates for phototherapy or systemic therapy by the investigator, defined as subjects with moderate-to-severe chronic plaque psoriasis uncontrolled by:
. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study medication (Day 0). Both women of childbearing potential and male patients with reproductive capacity must agree to use highly effective contraceptive methods during the study and for 15 weeks following the last dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving PASI75 at Week 24
Timeframe: Baseline to Week 24
2
Proportion of Participants Achieving IGA Score of 0 or 1 at Week 24
Timeframe: Baseline to Week 24
Trial details
NCT IDNCT07485764
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology