Psoriasis
Conditions
Interventions
Ustekinumab monotherapy group:Ustekinumab
Ustekinumab-to-Ixekizumab sequential-therapy group:Ustekinumab and Ixekizumab
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old 2. Moderate to severe plaque psoriasis (PASI >= 3 points or BSA score >= 3 points) 3. Suitable for systemic treatment or phototherapy (previous treatment failure, intolerance or contraindication) 4. Have discontinued local treatment for more than 2 weeks before enrollment, and have received systemic treatment for more than 1 month 5. Male or female of childbearing age must agree to use effective contraceptive measures 6. Sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Allergic to ustekinumab, iguratimod or any of their excipients 2. Other types of active psoriasis (such as pustular, erythrodermic, or mainly punctate) apart from plaque psoriasis 3. Active infections (such as TB, HIV, HBV, HCV - need to be screened and managed according to the guidelines) 4. Chronic or recurrent infection history 5. Active malignant tumors or a history of malignant tumors within the last 5 years (except for fully treated skin basal cell carcinoma, squamous cell carcinoma or cervical carcinoma in situ) 6. Severe, progressive or uncontrolled systemic diseases (cardiovascular, liver, kidney, neurological, metabolic, hematological, etc.) 7. Recent (usually referring to within a certain time window before screening) administration of live vaccines or planned to be administered during the study period 8. Pregnant or lactating women 9. Any condition that the investigator deems may increase risk or interfere with the study assessment 10. Using local treatment, phototherapy, or systemic treatment (traditional Chinese medicine, traditional drugs, biologics, small molecule drugs, etc.) within 2 weeks before the baseline 11. Unable to follow up on time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the efficacy differences between the sequential regimen of 'IL-12/23p40 inhibitor ? IL-17A inhibitor' and the single biologic agent regimen at Week 16 of treatment, with the PASI100 improvemen; | — |
Secondary
| Measure | Time frame |
|---|---|
| To explore the potential mechanisms underlying therapeutic responses: by analyzing changes in lesional tissue immunohistochemistry (IHC) and transcriptomics (RNA-Seq) before and after treatment, chang;To evaluate retreatment efficacy after relapse, compare the PASI 100 response rates (PASI = 0) of ustekinumab versus ixekizumab in patients who relapsed after drug discontinuation, to guide clinical r;To evaluate the durability of PASI 100 response following treatment withdrawal, patients who attained PASI 100 at Week 16 were followed up off-treatment, with the time to loss of PASI 100 response (de;To explore additional clinical outcomes of biologic therapy—including Week-16 PASI score changes, correlations between pruritus VAS improvement and efficacy/safety, and SAE incidence through Week 52—t;To compare the efficacy and safety of biologic agents, focusing on ustekinumab (IL-12/23 inhibitor) versus ixekizumab (IL-17A inhibitor), using Week-16 PASI 75/90 response rates, DLQI improvement, and; | — |
Countries
China
Contacts
Public ContactKexiang Yan
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed