Hidradenitis Suppurativa Study of Izokibep
Hidradenitis Suppurativa
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
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 to 75 years of age Type of Subject and Disease Characteristics Diagnosis of HS for ≥ 6 months prior to first dose of study drug Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage 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 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 History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD 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 within 3 months prior to first dose of study drug 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Group 1: Placebo subcutaneous once weekly
Group 2: Izokibep subcutaneous once weekly
Participants will receive placebo every week to week 15, then izokibep to week 51.
Participants will receive izokibep every week to week 51