A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa

ACELYRIN, Inc.0 个研究点目标入组 180 人开始时间: 2022年4月19日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ACELYRIN, Inc.
入组人数: 180

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Subject (male and female) must be = 18 and = 75 years
•- Diagnosis of HS for = 1 year
•- HS lesions present in = 2 distinct anatomic areas, one of Hurley Stage II or Hurley Stage III
•- A total AN count of = 3 at screening
•- Subject must have had an inadequate response to oral antibiotics (defined as = 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
•- Subject must agree to use daily (throughout the duration of the study) one of the following over-the-counter topical antiseptics on their body areas affected with HS suppurativa lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or diluted bleach in bathwater.
•- Subject must be willing to complete a daily skin pain diary 7 consecutive days prior to Day 1
•- No known history of active tuberculosis
•- Subject has a negative tuberculosis test at screening
•- Male and Female participants of childbearing potential must use effective methods of contraception
•For a complete overview of the inclusion criteria refer to the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 162
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

排除标准

•- Draining fistula count of > 20 at screening or Day 1 prior to enrollment/randomization
•- Outpatient surgery = 8 weeks prior or inpatient surgery = 12 weeks prior to enrollment/randomization
•- Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments
•- History of major autoimmune, chronic inflammatory, or connective tissue disease (eg, rheumatoid arthritis, psoriasis, psoriatic arthritis, axial spondyloarthritis, system lupus erythematosus, IBD) other than HS
•- Chronic pain not associated with HS (eg, fibromyalgia).
•- Uncontrolled, clinically significant system disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), renal disease, liver disease or hypertension
•- History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease
•- Malignancy within 5 years except treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
•- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. Subjects must have been on a stable dose within the 3 months prior to the first dose of study intervention
•- History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the Investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
•- Any active infection for which oral anti-infectives (antibiotics, antivirals, antifungals) were used = 14 days prior to first dose of study intervention (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS)
•- A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) = 30 days prior to first dose of study intervention
•- Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject
•- Candida infection requiring systemic treatment = 3 months prior to first dose of study intervention
•- Tuberculosis or fungal infection seen on available chest x-ray taken = 3 months of screening or at screening
•- Known history of human immunodeficiency virus (HIV)
•- Previous exposure to izokibep or any other IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab)
•- Prior exposure to biologics that had a potential or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri ®], rituximab [Rituxan®], or efalizumab [Raptiva®])
•- Exposure to TNF-a inhibitors, IL-1, IL-12, IL-23, or IL-12/23 receptor inhibitors within 5 half-lives prior to first dose of study intervention
•- Exposure to the following = 12 weeks prior to first dose of study intervention
•Other experimental or commercially available biologic or biosimilar therapies (within 12 weeks or 5 half-lives, whichever is longer)
•IV gamma-globulin or Prosorba column therapy
•Exposure to the following = 4 weeks prior to first dose of study intervention
•JAK inhibit

研究者

发起方

ACELYRIN, Inc.

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