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

NCT07485764 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025Lunshenzi(0610-03)
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Plaque Psoriasis; Moderate-to-severe Plaque Psoriasis; Overweight , Obesity

Keywords

Metformin; Secukinumab; IL-17 Inhibitor; Randomized Controlled Trial; Double-Blind; Placebo-Controlled; Chinese Patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Week 24

Secondary Outcomes (8)

• 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

Study Arms (2)

Metformin + Secukinumab

EXPERIMENTAL

Participants receive secukinumab (300 mg subcutaneous injection at Weeks 0, 1, 2, 3, 4, then every 4 weeks thereafter) plus metformin (oral, starting at 500 mg/day, titrated weekly to a maximum of 2000 mg/day as tolerated, then maintained)

Drug: Secukinumab 300mg s.c.; Drug: Metformin

Placebo + Secukinumab

PLACEBO COMPARATOR

Participants receive secukinumab (same dosing regimen as the experimental group) plus placebo tablets (identical in appearance to metformin, administered orally following the same titration schedule).

Drug: Secukinumab 300mg s.c.; Drug: Placebo

Interventions

Secukinumab 300mg s.c. DRUG

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.

Metformin + Secukinumab; Placebo + Secukinumab

Metformin DRUG

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.

Metformin + Secukinumab

Placebo DRUG

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

Placebo + Secukinumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Lactating women agree to discontinue breastfeeding during the study and for 15 weeks following the last dose of study medication.
• Subjects must be capable of effective communication with investigators and adhere to the clinical trial protocol to complete all study requirements. -

You may not qualify if:

• : 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).
• : Drug-induced psoriasis (e.g., new-onset or exacerbated psoriasis caused by beta-blockers, calcium channel blockers, or lithium).
• : 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.
• : Prior use of secukinumab or other IL-17A/IL-17R-targeted biologic agents within 12 weeks prior to screening.
• : History of malignancy within the past 5 years (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ).
• : Active inflammatory diseases other than psoriasis that may confound the evaluation of secukinumab efficacy.
• : Metabolic or inflammatory diseases (e.g., type 2 diabetes) that may confound the evaluation of metformin efficacy.
• : History of lymphoproliferative disorders (e.g., lymphoma, lymphadenopathy) or splenomegaly.
• : Opportunistic infections within 6 months prior to screening (e.g., herpes zoster, CMV, Mycoplasma, Pneumocystis jirovecii, histoplasmosis, candidiasis, aspergillosis, NTM).
• : Chronic or recurrent infectious diseases (e.g., chronic hepatitis, pyelonephritis) or severe/life-threatening infections within 6 months prior to screening; current signs/symptoms suggestive of infection (e.g., fever, cough, dysuria, abdominal pain, diarrhea, infected skin wounds).
• : High risk of infection (e.g., leg ulcers, indwelling urinary catheters, recurrent chest infections, bedridden/wheelchair-bound status).
• : Major surgery within 8 weeks prior to screening or planned during the study, deemed to pose unacceptable risk by the investigator.
• : Live virus/bacterial vaccines (e.g., BCG) within 6 weeks prior to screening or planned during the study/within 15 weeks after last dose.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Psoriasis; Overweight; Obesity

Interventions

secukinumab; Metformin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Juan Tao, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Yang, MD

CONTACT

+86 181 7133 9758; fly_y1@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin (experimental group) or secukinumab plus placebo (control group). The study includes a screening period, induction period, maintenance period, and follow-up period, with a total duration of 60 weeks.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)