Psoriasis
Conditions
Interventions
Control group:Deucravacitinib (TYK2 inhibitor) group: Deucravacitinib once daily, one tablet (6mg) each time, for 16 weeks of use.
Experimental group:Deucravacitinib (TYK2 inhibitor) combined with calcipotriol betamethasone group: Deucravacitinib is taken once daily, one tablet (6mg) each time, for 16 weeks of use
calcipotriol betamethasone is applied once daily, with a maximum application area of less than 30% of the body surface area, twice a week for 4 weeks.
Sponsors
Huashan Hospital Of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients visiting the psoriasis specialty clinic, diagnosed with moderate to severe plaque psoriasis. (2) Eligible for phototherapy or systemic treatment, males or females aged 18 years or older, and under 80 years old. (3) At the screening visit and on Day 1, the Body Surface Area (BSA) involvement is = 3% or the Psoriasis Area and Severity Index (PASI) score is = 3. (4) Female patients of childbearing potential must agree to use correct and highly effective contraceptive measures, must not become pregnant, lactate, breastfeed, or plan to conceive during the study; male study participants must agree to use contraceptive measures as instructed. (5) Patients have failed biologic therapy. (6) Study participants voluntarily participate in this study and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have combined other topical drug treatments, traditional Chinese medicine, phototherapy, biologics, systemic non-biologic psoriasis drugs, and/or any systemic immunosuppressants. (2) Abnormal laboratory tests: Absolute white blood cell count 3 times the upper limit of normal (ULN) Total free and/or conjugated bilirubin > 2 times ULN eGFR 160 mmHg or diastolic blood pressure (BP > 100 mmHg) New York Heart Association Class III or IV congestive heart failure History of cancer, cancer, or lymphoproliferative disease within 5 years prior to enrollment (except for skin basal cell carcinoma and squamous cell carcinoma that have been removed and treated with no evidence of recurrence, or in situ cervical cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the PASI 75 response rate at week 4.;Compare the sPGA0/1 response rate at week 4.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the PASI 75 response rate at week 16;Compare the sPGA 0/1 response rate at week 16.;Compare the PASI 90 response rates at weeks 4 and 16;Compare the PASI 100 response rates at weeks 4 and 16.; Compare the DLQI 0/1 response rates at weeks 4 and 16.;Compare the improvement in PASI scores from baseline at weeks 4 and 16.; | — |
Countries
China
Contacts
Public ContactXu jinhua
Huashan Hospital Of Fudan University
Outcome results
None listed