Psoriasis
Conditions
Interventions
Telricizumab monotherapy group:Telricizumab (100mg) was subcutaneously injected at weeks 0, 4, 16, 28, 40, and 52.
Telricizumab followed by cilizumab treatment group:Telricizumab: Subcutaneously inject telricizumab (100mg) at weeks 0, 16, 28, 40, and 52.
Icizumab: 80mg is subcutaneously injected in the 4th week
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Moderate to severe plaque psoriasis (as defined by psoriasis guidelines). 3. Suitable for systemic therapy or phototherapy (prior treatment failure, intolerance, or contraindication). 4. Discontinue topical treatment for >2 weeks and systemic treatment for >1 month before enrollment. 5. Female/male of childbearing potential agree to use effective contraceptive measures. 6. Sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to tildrakizumab, ixekizumab, or any of their excipients. 2. Active psoriasis types other than chronic plaque psoriasis (such as pustular, erythrodermic, or guttate psoriasis). 3. Evidence of active infection, including but not limited to tuberculosis, chronic active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 4. History of chronic or recurrent infection that, in the investigator's opinion, may increase the risk of study participation. 5. Currently having active malignant tumor, or history of malignant tumor within the past 5 years (except for those who have undergone radical tumor surgery or treatment for >5 years with confirmed no recurrence or metastasis). 6. Presence of severe, progressive, or uncontrolled hepatic, renal, cardiovascular, respiratory, neurological, endocrine, or hematological diseases that, in the investigator's judgment, may pose an unacceptable risk to the subject. 7. Received live vaccine within 4 weeks before screening, or planned to receive live vaccine during the study period. 8. Pregnant or breastfeeding women. 9. Currently has or has a history of severe psychiatric disorders that, in the investigator's opinion, may affect the subject's ability to comply with the study procedures. 10. Received protocol-prohibited therapies within the specified period before baseline (see inclusion criterion 5). 11. Any other condition that, in the investigator's judgment, may increase the risk to the subject, interfere with the study assessments, or affect the subject's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects achieving PASI 100 (or PASI 0) at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving PASI 75 and PASI 90 at Weeks 16, 28, 40, and 52.;Change from baseline in DLQI score;Proportion of subjects achieving PASI 100 at Weeks 28, 40, and 52.;Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and the proportion of discontinuations, interruptions, or withdrawals from the study due to AEs.;Proportion of patients losing PASI 100 by Week 52 and median time to loss among those who discontinued at Week 16;Proportion of subjects achieving a PGA score of 0 (clear) or 1 (almost clear);Body surface area (BSA) : It assesses the percentage of body surface area affected by psoriasis lesions; | — |
Countries
China
Contacts
Public ContactYan Kexiang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed