A Phase 2b Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS). This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.
⁃ 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.