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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02904902
Eligibility Criteria:
Inclusion Criteria:
* Participant must have a diagnosis of HS;
* Participant must have any HS symptom at least 6 months prior to Baseline;
* HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
* Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
* Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.
Exclusion Criteria:
* Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
* Any other active skin lesion or condition that may interfere with assessment of HS;
* Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
* Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
* Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
* Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02904902
Study Brief:
Protocol Section:
NCT02904902