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

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.
• •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.