Hidradenitis suppurativa
Conditions
Interventions
low dose group:HB0043 30mg
High dose group:HB0043 100mg
Middle dose group:HB0043 50mg
Sponsors
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Understand the study procedure and sign an informed consent form (ICF) in person; 2. Male or female >=18 years old at the time of signing the ICF; 3. Pre-screening history of suppurative hidradenitis (HS) >=6 months; 4. The definition of moderate to severe HS must be met, and the following three conditions must be met: 1) The lesions were present in at least 2 different anatomic regions; 2) One of the areas must be at least Hurley Level II or III; 3) The total number of abscesses and inflammatory nodules was >=3; 5. Oral antibiotic therapy for HS should be taken before administration, and the dose and frequency of administration should be unchanged within 4 weeks before administration, and the dose and frequency of administration should be unchanged during the trial; 6. Subjects must agree to use an over-the-counter fungicide (chlorhexidine, benzoyl peroxide, etc.) at the lesion site daily during the trial period; 7. Within 6 months from the date of signing the ICF to the last dose, the subject and his/her partner are not planning to have children and are voluntarily using effective contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Allergic to HB0043 or any component in HB0043, or allergic to biologics, or have had a severe drug allergic reaction in the past; 2. Total number of fistulas at baseline =20; 3. Presence of other active autoimmune diseases other than HS at screening, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, uveitis, etc; 4. There are any other active skin diseases or symptoms that may affect the HS assessment at the time of screening; 5. Screening for a history of lymphoproliferative disease or any known malignancy in the 5 years prior to the visit (except for treated squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast that is considered cured); 6. Infection-related exclusion criteria (meet any of the following conditions) : 1) Patients with a history of chronic or recurrent infection; 2) A history of serious life-threatening infection within 6 months prior to screening; 3) Subjects who are considered by the investigator to have a high risk of infection (e.g. leg ulcers, indwelling catheters, persistent or recurrent chest infections, etc.); 4) Infections other than HS that require treatment with systemic antibiotics (other than the common cold) are present within 2 weeks prior to administration. 7. TB related exclusion criteria: 1) The medical history, symptoms and related test results of the subjects indicated active tuberculosis during screening; 2) The IGRA results are positive (if the subject has no clinical symptoms related to active TB and the results of chest CT examination at the time of screening do not affect the drug safety of the subject, admission is allowed); 3) If the IGRA result is uncertain/suspiciously positive, one review is allowed. If the review is still suspiciously positive/inconclusive, and the results of chest CT examination during screening will not affect the drug safety of the subjects, they are allowed to be enrolled; 8. Present witfarch any of the following cardiovascular and cerebrovascular diseases in the 3 months prior to screening: moderate to severe congestive heart failure (New York Heart Association Class III or IV); 1).Unstable angina requiring hospitalization, myocardial intion, coronary artery bypass grafting, percutaneous coronary intervention (except diagnostic angiography);2).Atrial or ventricular arrhythmia requiring hospitalization, pacemaker or defibrillator implantation;3).Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack; 9. Participants with serious underlying diseases, such as heart, lung, liver, kidney, blood, metabolic, endocrine, digestive, neurological, psychiatric, or brain diseases, who have been assessed by the investigator as unsuitable for participation in this study; 10. Patients with a history of recurrent herpes zoster or herpes simplex within 2 months before screening or in the past; 11. There were clinically significant electrocardiogram abnormalities in the patients during screening, which may pose risks according to the investigators; 12. Any of the following abnormal laboratory findings are present at screening or baseline: 1) Blood biochemistry: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin (TBIL) > 2 times the upper limit of normal (ULN); 2) Blood routine: hemoglobin (Hb) concentration for male < 85 g/L, female < 80 g/L); 3) Infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety In 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| HiSCR75 On 24 weeks of patients;counts of Abscesses, inflammatory nodule and tunnels on 16 weeks; | — |
Countries
China
Contacts
Public ContactFuren Zhang
Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences
Outcome results
None listed