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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01468233
Eligibility Criteria:
Inclusion Criteria:
* Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
* HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
* Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
* Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
* Subject must have a total AN count of greater than or equal to 3 at baseline.
Exclusion Criteria:
* Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
* Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.
* Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
* If entering the study on concomitant oral analgesics for non-HS related pain:
* Subject on opioid analgesics within 14 days prior to Baseline visit;
* Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01468233
Study Brief:
Protocol Section:
NCT01468233