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Clinical Trial NCT07485764 for Psoriasis, Plaque Psoriasis, Moderate-to-severe Plaque Psoriasis, Overweight , Obesity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients Phase 4 186 Randomized Double-Blind Placebo-Controlled Combination Therapy
A total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plu...
Show MoreA 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
- 2025Lunshenzi(0610-03)
Secukinumab
IL-17 Inhibitor
Randomized Controlled Trial
Double-Blind
Placebo-Controlled
Chinese Patients
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMetformin + Secukinumab 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) | 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 ...Show More 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. |
Placebo ComparatorPlacebo + Secukinumab 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). | 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 ...Show More Placebo Placebo tablets matching metformin in appearance, administered orally following the same titration schedule. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Proportion of Participants Achieving PASI90 at Week 24 | Percentage of participants achieving at least 90% improvement in PASI score from baseline to Week 24 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 24 to Week 52 |
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. -
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.
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.
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyHubei