A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa - 22107

Tonami Toshiki0 个研究点目标入组 40 人开始时间: 2023年12月9日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•1.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
•2.18 to 75 years of age
•Type of Subject and Disease Characteristics
•3.Diagnosis of HS for >= 6 months prior to first dose of study drug
•4.Hidradenitis suppurativa lesions present in >= 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III
•5.A total abscess and inflammatory nodule (AN) count of >= 5 at screening and Day 1 prior to enrollment/randomization
•6.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
•7.Must agree to use daily over-the-counter topical antiseptics
•8.Subject must be willing to complete a daily skin pain diary
•Other protocol defined Inclusion criteria may apply

•Medical Conditions
•1.Draining fistula count of > 20
•2.Outpatient surgery <= 8 weeks prior or inpatient surgery <= 12 weeks prior to enrollment/randomization
•3.Other active skin disease or condition that could interfere with study assessments
•4.History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD
•5.Chronic pain not associated with HS
•6.Uncontrolled, clinically significant system disease
•7.History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
•8.Malignancy within 5 years
•9.The subject is at risk of self-harm or harm to others
•10.Active infection or history of certain infections
•11.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)
•12.Known history of human immunodeficiency virus (HIV)
•Other protocol defined Exclusion criteria may apply

发起方

Tonami Toshiki