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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT06993233
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants with HS of more than 6 months duration,
* 18 years of age at screening visit,
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),
* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,
* Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,
* Total draining tunnel count less than 20
Exclusion Criteria:
* Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,
* Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
* Prior treatment with any of the following medications before baseline:
1. Any other systemic therapy for HS (28 days before baseline)
2. Any IV anti-infective therapy (14 days before baseline)
* History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06993233
Study Brief:
Protocol Section:
NCT06993233