psoriasis
Conditions
Interventions
Monotherapy Group:Secukinumab in combination with placebo treatment
Combination Therapy Group:Secukinumab in combination with metformin therapy
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Subjects voluntarily participate in the study and sign the informed consent form. 2: Aged 18–75 years (inclusive) at the time of signing informed consent, male or female. 3: Diagnosed with chronic plaque psoriasis for >=6 months prior to the first study drug administration. 4: Overweight/obesity: Body mass index (BMI) >=25 kg/m². 5: 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. 6: 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. 7: 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. 8: Lactating women agree to discontinue breastfeeding during the study and for 15 weeks following the last dose of study medication. 9: Subjects must be capable of effective communication with investigators and adhere to the clinical trial protocol to complete all study requirements.
Exclusion criteria
Exclusion criteria: 1: BMI 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving PASI 75 at Week 24;The proportion of subjects achieving IGA(0~1) at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving PASI90 at Week 24;The proportion of subjects achieving PASI 75 at Week 52;The proportion of subjects achieving IGA(0~1) at Week 52;At Week 24, improvement in itching severity as assessed by the Numerical Rating Scale (NRS) score.;Improvement in Dermatology Life Quality Index (DLQI) scores at Week 24;At Week 24, the proportion of subjects achieving Dermatology Life Quality Index (DLQI) scores of 0 or 1;Proportions of subjects achieving PASI50/75/90/100 and IGA scores of 0–1 at different time points.;The proportion of subjects achieving PASI50 but not PASI75at Week 24 who subsequently achieved PASI75, PASI90 , or PASI100 at Week 52; | — |
Countries
China
Contacts
Public ContactTao Juan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed