PsoriasisPhase 4NCT07485764
Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients
A Phase 4 study testing Secukinumab 300mg s.c. and Metformin in people with Psoriasis and Plaque Psoriasis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis, Moderate-to-severe Plaque Psoriasis
- What is being tested?
- Secukinumab 300mg s.c. and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jun 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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. -
Who cannot join
- 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.
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- 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.
- 10: Opportunistic infections within 6 months prior to screening (e.g., herpes zoster, CMV, Mycoplasma, Pneumocystis jirovecii, histoplasmosis, candidiasis, aspergillosis, NTM).
- 11: 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).
- 12: High risk of infection (e.g., leg ulcers, indwelling urinary catheters, recurrent chest infections, bedridden/wheelchair-bound status).
- 13: Major surgery within 8 weeks prior to screening or planned during the study, deemed to pose unacceptable risk by the investigator.
- 14: Live virus/bacterial vaccines (e.g., BCG) within 6 weeks prior to screening or planned during the study/within 15 weeks after last dose.
- 15: Participation in another clinical trial within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).
- 16: Laboratory abnormalities: Hemoglobin <8.5 g/dL WBC <2,500/μL ANC <1,500/μL Platelets <100,000/μL ALT/AST >2×ULN Creatinine >176.8 μmol/L (2.0 mg/dL) 17: Active hepatitis B (positive HBsAg). 18: Positive HCV antibody. 19: HIV infection or positive HIV antibody. 20: Syphilis infection. 21: Active or latent tuberculosis at screening. 22: Hypersensitivity to trial drug excipients, murine/human proteins, or immunoglobulin products.
- 23: Inability to communicate/comply (e.g., psychiatric disorders, frequent travel, lack of motivation).
- 24: Other conditions deemed by the investigator to compromise study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jing Yang, MD, +86 181 7133 9758, fly_y1@163.com
About this study
Official title: 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
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.
Read more
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.
- Being tested
- Secukinumab 300mg s.c., Metformin, Placebo
- Keywords
- Metformin, Secukinumab, IL-17 Inhibitor, Randomized Controlled Trial, Double-Blind, Placebo-Controlled, Chinese Patients
- Medical subject headings
- Psoriasis, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MetforminDrug
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.
PlaceboDrug
Placebo tablets matching metformin in appearance, administered orally following the same titration schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Drug: Secukinumab 300mg s.c.; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 24
Secondary outcomes (8)
Proportion of Participants Achieving PASI90 at Week 24
Percentage of participants achieving at least 90% improvement in PASI score from baseline to Week 24
Measured: 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.
Measured: Baseline to 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.
Measured: Baseline to 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.
Measured: Baseline to Week 24
Proportion of Participants with DLQI Score of 0 or 1 at Week 24
Percentage of participants achieving a DLQI score of 0 or 1 (no impact on quality of life) at Week 24.
Measured: Baseline to Week 24
Change in Pruritus NRS Score at Week 24
Mean change in pruritus Numerical Rating Scale (NRS) score from baseline to Week 24.The pruritus NRS is a 11-point scale with scores ranging from 0 (no itch) to 10 (worst imaginable itch), where higher scores indicate more severe pruritus.
Measured: Baseline to Week 24
Proportion of Participants with ≥2.5% Weight Loss at Week 24
Percentage of participants achieving at least 2.5% reduction in body weight from baseline to Week 24.
Measured: 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
Among participants who achieved at least 50% improvement in PASI score (PASI50) but did not achieve 75% improvement (PASI75) at Week 24, the percentage who subsequently achieve PASI75, PASI90, or PASI100 at Week 52.
Measured: Week 24 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Tao, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485764
- Sponsor's protocol ID
- 2025Lunshenzi(0610-03)
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided