Moderate to severe immune checkpoint inhibitor-related psoriasis
Conditions
Interventions
Experimental group:Picankibart Injection
Control Group (Treatment methods other than Picankibart injection):None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants must be able to understand and voluntarily sign written informed consent, and must have a sufficient understanding of the study objectives, procedures, and potential adverse reactions. For individuals with limited capacity for civil conduct, written informed consent shall be signed by their legal guardian. 2. Participants must be able to communicate adequately with the investigators, and be willing and able to complete treatment, follow-up visits, and relevant examinations as required by the study protocol. 3. Age >=18 years, male or female. 4. Participants must have a confirmed diagnosis of malignant tumor by an oncologist, and have previously received or be currently receiving immune checkpoint inhibitor therapy, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies. The occurrence of cutaneous immune-related adverse events (cirAEs) must have a clear temporal association with ICI treatment and be jointly assessed by dermatologists and oncologists as related to ICI therapy. 5. Participants must be diagnosed by a dermatologist, based on medical history, morphology of skin lesions, and pathological findings when necessary, with immune checkpoint inhibitor-related psoriasis or psoriasiform eruption, which may present as new-onset psoriasis or significant exacerbation of pre-existing psoriasis. 6. At the screening visit, skin lesions must be moderate to severe, meeting any one of the following criteria: (1) PASI >=3; (2) sPGA >=3; (3) CTCAE grade >=2; and, in the investigator's judgment, systemic treatment is required to control the disease. 7. Laboratory tests during the screening period must meet all of the following criteria: (1) AST =30 mL/min/1.73 m^2; (4) total white blood cell count >=3.0 × 10^9/L; (5) absolute neutrophil count, ANC >=1.5 × 10^9/L; (6) platelet count >=100 × 10^9/L; (7) hemoglobin >=100 g/L for males and >=90 g/L for females. 8. Hepatitis B surface antigen must be negative. If HBsAg is positive, HBV-DNA must be <500 IU/mL, and the participant must have received and plan to continue standardized antiviral therapy. Hepatitis C antibody must be negative, or if positive, HCV-RNA must be negative. Syphilis serology must be negative; participants with TP-Ab positivity but negative RPR/TRUST may be enrolled at the investigator's discretion. HIV antibody must be negative. 9. Tuberculosis screening must be negative, or participants with previous latent tuberculosis must have completed adequate standardized treatment and currently have no clinical or radiological evidence of active tuberculosis. 10. Women of childbearing potential must have a negative urine or serum pregnancy test during the screening period and agree to use reliable contraception during study treatment and for at least 6 months after the last dose. Men of childbearing potential must agree to use effective contraception during the same period.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of severe hypersensitivity to picankibart; 2. Participants with active severe infection at screening, including but not limited to sepsis, pneumonia, active herpes zoster, fungal infection, or any other condition requiring intravenous anti-infective therapy, for which the investigator considers initiation of biologic therapy temporarily inappropriate; 3. Participants with active tuberculosis or suspected active tuberculosis, including those with typical symptoms such as persistent fever, night sweats, weight loss, or chronic cough, or imaging findings suggestive of active lesions, in whom active tuberculosis cannot be excluded after comprehensive assessment; 4. Participants who are HBsAg-positive with HBV-DNA >=500 IU/mL, or those with HBV-DNA <500 IU/mL but who have not received or do not plan to receive standardized antiviral therapy; participants who are HCV-RNA positive; participants who are HIV antibody positive; or participants with positive syphilis serology accompanied by manifestations of active syphilis; 5. Participants with other active autoimmune or inflammatory skin diseases that may seriously interfere with efficacy and safety assessments, such as bullous pemphigoid, generalized eczema, or severe drug eruption, and for whom the investigator considers it difficult to distinguish skin manifestations related to psoriasis or the investigational drug; 6. Participants with severe cardiovascular, hepatic, renal, neurological, or hematopoietic disorders that may significantly increase the risks associated with biologic therapy, such as recent myocardial infarction or stroke within the past 6 months, uncontrolled heart failure, severe liver cirrhosis, or end-stage renal disease; 7. Participants with an extremely short expected survival due to malignancy, for example, an estimated survival of <3 months, for whom the investigator considers follow-up assessments difficult to complete; 8. Participants who have previously received other IL-23 inhibitors before screening; 9. Participants who have received IL-17 inhibitors within 24 weeks before screening; 10. Participants who have received TNF-alpha inhibitors within 12 weeks before screening; 11. Participants who have received conventional systemic therapies, such as acitretin, methotrexate, cyclosporine, or apremilast, within 4 weeks before screening; 12. Participants who have participated in another interventional clinical trial and received investigational treatment within 4 weeks before screening; 13. Women who are pregnant or breastfeeding, or women who plan to become pregnant during the study period or within 6 months after the last dose; individuals who plan to conceive, donate sperm, or donate ova during the same period; 14. Participants with psychiatric or cognitive impairment, drug abuse, alcohol abuse, or other conditions that, in the investigator's judgment, may seriously affect compliance or the authenticity of informed consent; 15. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak Pruritus Numerical Rating Scale-4;Overall Survival;Dermatology Life Quality Index;Static Physician’s Global Assessment;Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactXiuyuan Wang
Zhongshan Hospital, Fudan University
Outcome results
None listed