pityriasis rubra pilaris
Conditions
Interventions
Experimental group:Ustekinumab
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 12 years, male or female; 2. Clinically and pathologically confirmed pityriasis rubra pilaris; 3. Moderate to severe patients (PASI >= 10, BSA >= 10%); 4. Patients receiving initial treatment or previously treated; previously treated patients must exclude the exclusion criteria in item 12; 5. Women of childbearing potential must have a negative pregnancy test during the screening period and before receiving the study drug for the first time (D1). Female and male participants (and their female partners) must use effective contraception from the screening period until at least 6 months after the last dose, and no plans for conception, sperm donation, or egg donation during this period; 6. Able to understand and comply with the clinical protocol requirements, willing to participate in the clinical trial, and provide written informed consent signed by the patient or their legal guardian.
Exclusion criteria
Exclusion criteria: 1.Presence of other inflammatory diseases, including but not limited to inflammatory bowel disease, uveitis, atopic dermatitis, etc., which, in the investigator’s judgment, may affect efficacy or safety assessments; 2.Presence of active autoimmune diseases, including but not limited to systemic sclerosis, systemic lupus erythematosus, etc., which, in the investigator’s judgment, may affect efficacy or safety assessments; 3.Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to screening, or active infection requiring oral antibiotics within 2 weeks prior to screening, where the investigator assesses that participation poses an uncontrollable risk; 4.Skin infections or other skin conditions that, in the investigator’s judgment, may affect the assessment of pityriasis rubra pilaris; 5.Known or suspected history of immunosuppressive conditions, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), or infections that, despite resolution, are deemed by the investigator as likely to recur frequently; 6.Suspected active Mycobacterium tuberculosis (TB) infection based on clinical symptoms, signs, chest imaging, medical history, or TB test results (patients with previously treated active TB or latent TB treated with anti-TB therapy for at least 4 weeks may be included upon investigator’s assessment); 7.History of lymphoproliferative disease, malignant tumors, or current malignancy (except for basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ cervical cancer cured for =1 year); 8.Presence of the following cardiac or cerebrovascular conditions: Unstable angina within 3 months prior to screening; Heart failure (New York Heart Association [NYHA] Class III or IV) within 3 months prior to screening; History of acute myocardial infarction, coronary stent implantation, or coronary artery bypass grafting within 3 months prior to screening; New-onset cerebrovascular events within 3 months prior to screening (including ischemic stroke, hemorrhagic stroke, transient ischemic attack, etc., excluding lacunar infarction); Uncontrolled severe arrhythmias within 3 months prior to screening (including ventricular tachycardia, ventricular fibrillation, second- or third-degree atrioventricular block, sick sinus syndrome, etc.); 9.Presence of severe or unstable conditions that, in the investigator’s opinion, may affect participant safety or prevent study completion, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, or psychiatric diseases; 10. During screening, the following test results indicate positivity: Hepatitis B virus (HBV) infection [defined as: (1) positive hepatitis B surface antigen (HBsAg), or (2) HBsAg negative but positive hepatitis B core antibody (HbcAb) (both require further testing for HBV DNA, and values exceeding the upper limit of the normal range need to be excluded)], hepatitis C virus antibody (HCV Ab) positive [requires further testing for HCV RNA (values exceeding the upper limit of the normal range need to be excluded)], human immunodeficiency virus antibody (HIV Ab) positive, serum syphilis treponemal antibody (TP Ab) positive [if TP Ab is positive, further testing with the rapid plasma reagin (RPR) test or toluidine red unheated serum test (TRUST) is required (positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index 50, PASI-50; | — |
Secondary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index 50, PASI-50;Body Surface Area, BSA;Physician’s Global Assessment, PGA;Psoriasis Area and Severity Index 90, PASI-90;Dermatology Life Quality Index, DLQI;Psoriasis Area and Severity Index 75, PASI-75; | — |
Countries
China
Contacts
Public ContactBin Yang
Dematology Hospital of Southern Medical University
Outcome results
None listed