A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Metformin in Combination With Secukinumab for the Treatment of Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Proportion of Participants Achieving PASI75 at Week 24
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blind study. Participants, investigators, care providers, and outcome assessors are all masked to treatment assignment. Placebo tablets identical in appearance to metformin are used to maintain blinding.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Moderate-to-severe plaque psoriasis (defined as):
- •Psoriasis Area and Severity Index (PASI) score \>=12 at screening and prior to first dose.
- •Investigator's Global Assessment (IGA) score \>=3 at screening and prior to first dose.
- •Stable disease within 2 months prior to randomization.
- •Deemed candidates for phototherapy or systemic therapy by the investigator, defined as subjects with moderate-to-severe chronic plaque psoriasis uncontrolled by:
- •Topical therapy and/or phototherapy and/or prior systemic therapy.
Exclusion Criteria
- •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).
- •3: Drug-induced psoriasis (e.g., new-onset or exacerbated psoriasis caused by beta-blockers, calcium channel blockers, or lithium).
- •4: Use of prohibited medications: Systemic non-biologic agents (e.g., glucocorticoids, leflunomide, methotrexate, cyclosporine, retinoids, azathioprine, mycophenolate mofetil, traditional Chinese medicines for psoriasis) within 4 weeks prior to screening.
- •Etanercept or its biosimilars within 4 weeks prior to screening; TNF-α inhibitors or their biosimilars within 12 weeks prior to screening.
- •Other biologic agents for psoriasis (e.g., IL-12/23 or IL-23 inhibitors) within 5 half-lives of the drug prior to screening.
- •5: Prior use of secukinumab or other IL-17A/IL-17R-targeted biologic agents within 12 weeks prior to screening.
- •6: History of malignancy within the past 5 years (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ).
- •7: Active inflammatory diseases other than psoriasis that may confound the evaluation of secukinumab efficacy.
- •8: Metabolic or inflammatory diseases (e.g., type 2 diabetes) that may confound the evaluation of metformin efficacy.
- •9: History of lymphoproliferative disorders (e.g., lymphoma, lymphadenopathy) or splenomegaly.
Outcomes
Primary Outcomes
Proportion of Participants Achieving PASI75 at Week 24
Time Frame: Baseline to 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
Time Frame: Baseline to Week 24
Percentage of participants achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 24.
Secondary Outcomes
- Proportion of Participants Achieving PASI90 at Week 24(Baseline to Week 24)
- Proportion of Participants Achieving PASI75/90/100 at Week 52(Baseline to Week 52)
- Proportion of Participants Achieving IGA 0/1 at Week 52(Baseline to Week 52)
- Change in DLQI Score at Week 24(Baseline to Week 24)
- Proportion of Participants with DLQI Score of 0 or 1 at Week 24(Baseline to Week 24)
- Change in Pruritus NRS Score at Week 24(Baseline to Week 24)
- Proportion of Participants with ≥2.5% Weight Loss at Week 24(Baseline to Week 24)
- Proportion of Participants Achieving PASI75/90/100 at Week 52 Among Those Who Achieved PASI50 but Not PASI75 at Week 24(Week 24 to Week 52)