Hidradenitis Suppurativa
Conditions
Interventions
control group:Placebo (200mg subcutaneously) every 2 weeks for the first 8 weeks
after unblinding, Xeligekimab (200mg subcutaneously) every 2 weeks for next 8 weeks.
experiment group:Xeligekimab (200mg subcutaneous injection) every 2 weeks for 8 weeks.
Sponsors
Department of Dermatology, Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Male or female aged 18-70 years 2: The presence of three or more skin lesions lasting more than 6 months 3: Even if the number of skin lesions dose not reach three or more, the abscess has progressed to ulceration, which lasts for more than 6 weeks. 4: The female patients have no plans to have children or donate eggs and voluntarily take high-efficiency physical contraception from the screening period to 6 months after the last administration. The male patients have no plans to have children or donate sperm and voluntarily take high-efficiency physical contraception from the screening period to 6 months after the last administration 5: Patients deemed by the investigator to be eligible to receive an IL-17 inhibitor 6: Patients provide written informed consent
Exclusion criteria
Exclusion criteria: 1: Any other active skin disease that may interfere with HS assessment 2: concomitant inflammatory bowel disease 3: allergic to any component of the study drug 4: Concurrent active tuberculosis. Patients with active TB can be included into the study if they have started adequate treatment and have completed anti-TB treatment at least four weeks before the start of the study 5: serious viral infections, such as: herpes encephalitis, herpes ophthalmopathy, disseminated herpes, positive hepatitis B surface antigen, positive hepatitis B core antibody (except HBV DNA copy number below the detection limit); Hepatitis C antibody, human immunodeficiency virus (HIV) antibody and anti-syphilis spiral antibody (TP-Ab) positive (except RPR or TRUST negative); 6: History of lymphoproliferative disorder or any known malignancy or malignancy 7: Significant abnormal liver, renal function and blood routine, including alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 2 times the upper limit of normal; Serum creatinine higher than the upper limit of normal value; Hemoglobin < 90 g/L; White blood cell count < 3.5×10^9/L, platelet count (PLT) < 100×10^9/L; Neutrophil count < 1.5×10^9/L; Abnormal results of other laboratory tests that may affect the completion of the trial or interfere with the outcome of the trial according to the investigator's judgment. 8. Unstable cardiovascular disease, defined as a history of clinical deterioration (e.g., unstable angina, acute coronary syndrome, or rapid atrial fibrillation) or hospitalization for a cardiac disorder within the previous 3 months 9: Recent drug therapy; Non-biologic immunomodulatory drugs, systemic use of corticosteroids, opioid analgesics, live vaccines, participation or planned participation in other investigational treatments 10: Pregnant, lactating, or women of childbearing age who plan to become pregnant during the study period 11. Any medical or psychiatric condition that the investigator believes would prevent the subject from completing the study per protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with Hidradenitis Suppurativa achieving clinical response (HiSCR) after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of control subjects with Hidradenitis Suppurativa achieving clinical response (HiSCR) after 16 weeks of treatment;Mean percentage of changes in AN count after treatment compared to baseline;Changes in IHS4 scores of subjects before and after treatment;Changes in pain severity before and after treatment;Improvement in the Dermatology Life Quality Index (DLQI) after treament;Changes of Patient global assessment (PtGA NRS) before and after treatment; | — |
Countries
China
Contacts
Public ContactWenhui Wang
Department of Dermatology, Peking University Third Hospital
Outcome results
None listed