Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT06685835
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of HS (confirmed by a dermatologist), with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
* Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.
* HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.
Exclusion Criteria:
* Draining tunnel count of ≥20 at the Baseline Visit.
* Surgical or laser intervention for an HS lesion during the Screening Period.
* Clinical diagnosis of Papillon-Lefèvre Syndrome.
* Participants with an absolute neutrophil count \<1,000/mm3 at the Screening Visit.
* Participants having active liver disease or hepatic dysfunction.
* Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
* Received systemic (intravenous or orally \[PO\]) antibiotic therapy within 8 weeks before the Baseline Visit
a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being stable for at least 8 weeks before the Baseline Visit and is expected to continue.
* Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
* Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
* Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
* Received any anti-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
* Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
* Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
Note: Other Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06685835
Study Brief:
Protocol Section:
NCT06685835