Plaque psoriasis
Conditions
Interventions
Patients with moderate to severe plaque psoriasis treated with tirilizumab:NA
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 years at screening. 2. First use of tirilizumab and have had chronic plaque psoriasis for at least 6 months. 3. Diagnosed with moderate-to-severe plaque psoriasis (2023 Chinese Psoriasis Treatment Guidelines criteria) at screening and baseline, and judged by the investigator to be suitable for treatment with tirucizumab. 4. Consent to contraception for the duration of the trial and for 6 months after the end of the last dose. 5. Patients voluntarily signed an informed consent and agree with regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of non-plaque psoriasis such as erythrodermic psoriasis, pustular psoriasis, pitting psoriasis or drug-induced psoriasis. 2. Received other biologic agents within 5 half-lives of the drug (systemic therapy or topical medications in combination with other non-biologic agents are permitted in this study). 3. History of malignancy or malignancy (except squamous cell carcinoma of the skin, basal cell carcinoma or localised cervical carcinoma in situ that has been successfully excised without evidence of recurrence and metastasis within 5 years). 4. Have an active, recurrent, chronic infection (tuberculosis, hepatitis, etc.) or malignant disease. 5. Has undergone, or plans to undergo during the study period, any major surgical procedure within 12 weeks prior to the first use of the trial medicinal product. 6. Evidence of severe, progressive or uncontrollable cardiovascular, neuromuscular, haematological, respiratory, digestive, urinary, endocrine or metabolic, neurological or psychiatric disease in patients. 7. Impaired hepatic or renal function or in the opinion of the treating physician, biologics should not be used. 8. Vaccination with live vaccines (inactivated vaccines do not need to be excluded). 9. Women who are pregnant, breastfeeding and preparing for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLQI/ HADS anxiety-depression/WPAI-GH scores;PASI 75 response; | — |
Countries
China
Contacts
Public ContactKejian Zhu
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed