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 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT05355805
Eligibility Criteria:
Inclusion Criteria:
General
* Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* 18 years to 75 years of age
Type of Subject and Disease Characteristics
* Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III.
* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.
* Subject 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.
* Must agree to use daily over-the-counter topical antiseptics.
* Subject must be willing to complete a daily skin pain diary for at least 3 days prior to Day 1 visit.
Exclusion Criteria:
Medical Conditions
* Draining fistula count of \> 20.
* Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization.
* Other active skin disease or condition that could interfere with study assessments.
* Chronic pain not associated with HS.
* Uncontrolled, clinically significant system disease.
* History of demyelinating disease or neurological symptoms suggestive of demyelinating disease.
* Malignancy within 5 years.
* The subject is at risk of self-harm or harm to others.
* Active infection or history of certain infections.
* Tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening (Exception: documented evidence of completed treatment and clinically resolved).
* Known history of human immunodeficiency virus (HIV).
Other protocol defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05355805
Study Brief:
Protocol Section:
NCT05355805