2024-515959-38-00招募中2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults with Moderate to Severe Hidradenitis Suppurativa – The CEDAR Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Insmed Inc.
- 入组人数
- 116
- 试验地点
- 33
- 主要终点
- Percent change from Baseline in total abscess and inflammatory nodule count (AN count) at Week 16
研究概览
简要总结
To evaluate the effect of brensocatib compared with placebo
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment Period 2
- 盲法
- Double (Monitor, Carer, Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult male or female participants ≥18 to ≤80 years of age at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •Participants have a diagnosis of HS (confirmed by a dermatologist) with a history of signs and symptoms consistent with HS for at least 6 months before the Screening Visit.
- •Participants have moderate or severe HS defined as a total of ≥6 inflammatory (inflammatory nodules and/or abscesses) lesions for at least 8 weeks before the Baseline Visit.
- •Participants have HS lesions in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline Visits.
- •Sex and Contraceptive/Barrier Requirements
- •Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male Participants: From Day 1 to at least 90 days after the last dose of study drug, male participants, who are not sterile, should refrain from donating fresh unwashed sperm and must be using effective contraception with female partners of childbearing potential. Male participants with pregnant or non-pregnant WOCBP partners must agree to use a male condom and should also be advised of the benefit for female partners to use an additional highly effective contraceptive method as defined in Section 10.4.
- •b. Female Participants: Women must be postmenopausal, surgically sterile, or using highly effective contraception methods (as defined in Section 10.4.2) from Day 1 to at least 90 days after the last dose of study drug. The Investigator or designee should explain the acceptable methods of birth control to the participant and instruct the participant to follow the direction.
- •Informed Consent
- •Capable of giving signed informed consent as described in Section 10.1.5 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
排除标准
- •Medical Conditions
- •Draining tunnel count of ≥20 at the Baseline Visit.
- •Other active skin disease or condition that could interfere with HS assessments
- •Surgical or laser intervention for an HS lesion during the Screening Period.
- •Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune compromised status, as judged by the Investigator.
- •Known history of HIV infection.
- •Established diagnosis of hepatitis B viral infection at the time of Screening, or positive for HBsAg at the time of Screening. a. Participants who have gained immunity for hepatitis B virus infection after vaccination b. Participants with positive HBcAb are eligible for the study only if hepatitis B virus DNA level is undetectable.
- •Established diagnosis of HCV infection at the time of Screening. Participants positive for hepatitis C antibody are eligible only if HCV RNA is negative.
- •History of malignancy in the past 5 years, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- •Have diagnosed periodontal disease and are either: a. Under active management by a dentist for this condition or b. Expected to have periodontal disease-related procedures within the study period.
- •Clinical diagnosis of Papillon-Lefèvre Syndrome.
- •Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participants participation in the study.
- •History of drug or alcohol abuse within 6 months before the Screening Visit.
- •Prior/Concomitant Therapy
- •Received systemic (IV or PO) antibiotic therapy within 8 weeks before the Baseline Visit. a. PO doxycycline or minocycline up to 100 mg PO BID is permitted provided the dosing regimen has been stable for at least 8 weeks before the Baseline Visit and is expected to continue
- •Received PO or transdermal opioid analgesics (except tramadol) for any reason within 4 weeks before the Baseline Visit.
- •Permitted analgesics for HS-related pain have not been at a stable dose regimen for at least 4 weeks before the Baseline Visit.
- •Received prescription topical therapies for the treatment of HS within 2 weeks before the Baseline Visit.
- •Received any anti-TNF-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
- •Received systemic nonbiologic therapies with potential therapeutic impact for HS within 4 weeks before the Baseline Visit.
- •Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
- •Received any live attenuated vaccine within 4 weeks before the Screening Visit and during the Screening Period.If a live vaccine has been administered, the participant should wait 4 weeks before Screening.
- •Prior/Concurrent Clinical Study Experience
- •Previously participated in a clinical study for brensocatib.
- •Participated in any other interventional clinical studies with an investigational medicinal product within 3 months or 5 half-lives, whichever is longer, before the Screening Visit.
- •Known history of hypersensitivity to brensocatib or any of its excipients.
- •Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. Diagnostic Assessments For the complete list and details of the principal exclusion criteria, please refer to section 5.2 in the Protocol v1.0 dd 12Jul2024
结局指标
主要结局
Percent change from Baseline in total abscess and inflammatory nodule count (AN count) at Week 16
Percent change from Baseline in total abscess and inflammatory nodule count (AN count) at Week 16
次要结局
- • Responder status for achieving HiSCR50 and HiSCR75 at Week 16 • Continuous secondary efficacy endpoints will be analyzed in the same fashion as the primary endpoint. For the detailed information on the secondary endpoint, please check the Protocol v1.0,12Jul2024, section 9.6, Secondary Endpoint Analyses
研究者
Medical Information
Scientific
Insmed Inc.
研究点 (33)
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