Immune-related Checkpoint Inhibitor-Related Psoriasis
Conditions
Interventions
Control Group:None
Methotrexate Injection Group:None
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is able to understand and voluntarily sign the written informed consent, fully understand the trial's content, process, and possible adverse reactions, and authorize the researchers to use their confidential health information in accordance with national/region and local privacy regulations. 2. The subject must be at least 18 years old at the time of signing the ICF, with no gender restrictions. 3. All women of childbearing potential must use highly effective contraception during the study treatment period and for 182 days after the last study treatment. 4. The subject must have a confirmed diagnosis of psoriasis-like immune-related adverse skin reaction (cirAE) following the use of immune checkpoint inhibitors (ICI) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4. 5. The subject must have a PASI score of >=3 at screening. 6. The subject must be an inpatient in the Department of Dermatology at Zhongshan Hospital. 7. Laboratory tests: Patients must meet the following criteria during the screening period: (1) AST = 60 mL/min/1.73m^2 calculated using the simplified MDRD formula.
Exclusion criteria
Exclusion criteria: 1. Patients confirmed to be allergic to the investigational drug or its excipients; 2. Female subjects who are already pregnant, breastfeeding, or planning to become pregnant during the study treatment period and within 26 weeks after the last dose of study treatment; 3. Patients with a history of chronic or recurrent infections (3 or more infections of the same type within 52 weeks) or recent severe infections (such as pneumonia or sepsis), including viral infections, or those requiring anti-infective treatment within 12 weeks prior to screening and during screening; 4. Patients with a history of HIV or positive HIV antibody at screening; 5. Patients with active tuberculosis, defined as active tuberculosis based on clinical symptoms (fever, cough, night sweats, and weight loss, etc.), signs, tuberculosis laboratory tests (detected by interferon-gamma release assays, such as QFT or T-SPOT, or other Mycobacterium tuberculosis tests), and/or imaging (CT) indicating active tuberculosis; 6. Patients with severe hematologic abnormalities, such as myelodysplasia, leukopenia, thrombocytopenia, or severe anemia; 7. Patients with vitamin B12 deficiency; 8. Patients receiving live or live-attenuated vaccines within 4 weeks prior to screening, during the study, or within 26 weeks after the last dose of study drug; 9. Patients using immunosuppressants or immunomodulators other than Metax® methotrexate injection (including systemic corticosteroids, oral methotrexate, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, 6-mercaptopurine, dapsone, tacrolimus, pimecrolimus, sirolimus, leflunomide, etc.); 10. Patients using JAK inhibitors or biologics (including ixekizumab, secukinumab, ustekinumab, tildrakizumab, guselkumab, tralokinumab, TNF-a inhibitors, etc.); 11. Patients receiving ultraviolet phototherapy; 12. Patients receiving any investigational treatment; 13. Patients with other diseases that the investigator believes may affect prognosis and survival; 14. Any other situations that the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak Pruritus Numerical Rating Scale-4;Body Surface Area;Dermatology Life Quality Index;Common Terminology Criteria for Adverse Events Version 5.0; | — |
Countries
China
Contacts
Public ContactJi Yang
Zhongshan Hospital, Fudan University
Outcome results
None listed