Hidradenitis Suppurativa Phase 2b Study of Izokibep

Ki vehet részt

• 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

Ki nem vehet részt

• Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
• Medical Conditions
• Other active skin disease or condition that could interfere with study assessments
• Uncontrolled, clinically significant system disease
• History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
• Malignancy within 5 years
• 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
• Draining fistula count of > 20
• Chronic pain not associated with HS
• The subject is at risk of self-harm or harm to others