Hidradenitis Suppurativa
Conditions
Interventions
Treatment group:Oral administration of Ivarmacitinib tablets 8 mg once daily (qd) for up to Week 48
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign a written informed consent form; 2. Subjects are able to understand and communicate with the researchers and comply with the study requirements; 3. Age at screening must be >=18 years and <=65 years, regardless of gender; 4. Prior to baseline, according to the diagnosis recommendations in the "Chinese Expert Consensus on Treatment of Anomalous Acne and Hidradenitis Suppurativa (2021 Edition)", diagnosed with hidradenitis suppurativa for at least 6 months; 5. Patients with moderate to severe HS; Definition of HS patients: at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules; inflammatory lesions affect at least 2 different anatomical regions; 6. At baseline, draining fistula count <= 20; 7. Poor response or intolerance to a sufficient course of oral antibiotics used for HS treatment; 8. Female subjects of childbearing potential must have a negative blood pregnancy test within 1 week prior to the first dose, must not be breastfeeding, and must agree to use effective contraception during the study and for 28 days after the last dose of the investigational product. For male subjects with female partners of childbearing potential, they must be surgically sterilized or agree to use effective contraception during the study and for 28 days after the last dose of the investigational product. Sperm donation is not allowed during the study.
Exclusion criteria
Exclusion criteria: 1.Any other active dermatological disease that may interfere with HS assessment, including skin infections (bacterial, fungal, or viral) requiring systemic therapy within 4 weeks after the baseline visit. 2.Subjects who must or wish to continue using prohibited medications (see Section 3.1 Prohibited Medications) or any other medications that may interfere with the safe conduct of this trial. 3.Received treatment with any investigational device or investigational drug within at least 30 days prior to the baseline visit or within 5 half-lives of the drug (whichever is longer). 4.Used prohibited study medications within the restricted time period prior to the baseline visit (see Section 3.1 Prohibited Medications). 5.Subjects with an active systemic infection within 2 weeks before baseline. At the investigator’s discretion, these subjects may be re-screened after completing treatment for the acute infection. 6.Undergone major surgery (assessed as major by the investigator, e.g., hip replacement, aneurysmectomy, gastric ligation) within 12 weeks prior to the first dose of study drug, or planning to undergo major surgery during the study. 7.Subjects with severe, progressive, or poorly controlled diseases other than HS at screening, including renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disorders. 8.Planning to use laser or other depilatory procedures on HS-affected areas during the trial. 9.Subjects with any documented active or suspected malignancy or history of malignancy within 5 years prior to the screening visit, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 10.History of hypersensitivity to any component of the study drug and/or to components of other products in the same class. 11.Subjects with relevant chronic infections as determined by the investigator, including human immunodeficiency virus (HIV) or viral hepatitis:Hepatitis B surface antigen (HBsAg) positive (if HBsAg negative but HBcAb positive and/or HBeAb positive, HBV DNA quantification is required; subjects with negative HBV DNA may be enrolled); Hepatitis C antibody (anti-HCV Ab) positive (HCV RNA testing is required; subjects with negative HCV RNA may be enrolled). Subjects may be re-screened if their acute infection resolves after appropriate treatment. 12. Subjects with active or latent tuberculosis (TB) during screening (subjects should be tested during the screening visit): (1) Subjects with active TB should be excluded. (2) Screen subjects using interferon-gamma release assays (IGRA) such as QuantiFERON or T-spot. IGRA-positive subjects will be excluded unless, in the investigator's judgment, these subjects have completed treatment for active or latent TB at the time of screening. (3) Subjects with indeterminate QuantiFERON results or invalid T-spot results at borderline values may undergo one repeat IGRA test. 13. Other situations deemed by the investigator as inappropriate for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hidradenitis Suppurativa Clinical Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale-30;International Hidradenitis Suppurativa Severity Score System (IHS4);Dermatology Life Quality Index DLQI;Hidradenitis Suppurativa Odor and Drainage Scale Score;Functional Assessment of Chronic Illness Therapy-Fatigue Scale Score; | — |
Countries
China
Contacts
Public ContactXian Jiang
West China Hospital, Sichuan University
Outcome results
None listed