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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 214
- 试验地点
- 72
- 主要终点
- Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
研究概览
简要总结
The primary purpose of the study is to evaluate the effect of brensocatib compared with placebo.
详细描述
This study includes 4 periods, i.e. Screening Period (35 days), Treatment Period 1 (up to Week 16), Treatment Period 2 (up to Week 36) and Follow-up Period (4 weeks). Participants who will complete 52 weeks of study treatment may be eligible to enroll in a separate open-label extension (OLE) study. In addition to this, participants who will be enrolled in the OLE study at the Week 52 Visit are not required to complete the Follow-up Period or the Week 56 Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Moderate or severe HS defined as a total of ≥6 inflammatory lesions (inflammatory nodules and/or abscesses) for at least 8 weeks before the Baseline Visit.
- •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.
排除标准
- •Draining tunnel count of ≥20 at the Baseline Visit.
- •Surgical or laser intervention for an HS lesion during the Screening Period.
- •Clinical diagnosis of Papillon-Lefèvre Syndrome.
- •Participants with an absolute neutrophil count <1,000/mm3 at the Screening Visit.
- •Participants having active liver disease or hepatic dysfunction.
- •Have diagnosed periodontal disease under active management by a dentist or expected to have periodontal disease-related procedures within the study period.
- •Received systemic (intravenous or orally [PO]) antibiotic therapy within 8 weeks before the Baseline Visit
- •a. Doxycycline or minocycline up to 100 mg twice daily is permitted provided the dosing regimen being 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-tumor necrosis factor (TNF)-α/other biologics treatment within 12 weeks or 5 elimination half-lives, whichever is longer, before the Baseline Visit.
- •Received systemic nonbiologic therapies (eg, corticosteroids and retinoids) for HS within 4 weeks before the Baseline Visit.
- •Received any immunomodulatory agents within 4 weeks before the Baseline Visit.
- •Note: Other Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo Followed by Brensocatib 10 mg
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.
干预措施: Placebo (Drug)
Placebo Followed by Brensocatib 40 mg
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.
干预措施: Placebo (Drug)
Placebo Followed by Brensocatib 40 mg
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 40 mg tablet, QD, orally for 36 weeks.
干预措施: Brensocatib (Drug)
Brensocatib 40 mg
Participants will receive brensocatib 40 mg tablet, QD, orally for 52 weeks.
干预措施: Brensocatib (Drug)
Placebo Followed by Brensocatib 10 mg
Participants will receive brensocatib-matching placebo tablet, QD, orally for 16 weeks, and then Brensocatib 10 mg tablet, QD, orally for 36 weeks.
干预措施: Brensocatib (Drug)
Brensocatib 10 mg
Participants will receive brensocatib 10 mg tablet, once daily (QD), orally for 52 weeks.
干预措施: Brensocatib (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Abscess and Inflammatory Nodule (AN) Count at Week 16
时间窗: Baseline and Week 16
次要结局
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16(Week 16)
- Percentage of Participants Achieving HiSCR75 at Week 16(Week 16)
- Percentage of Participants Achieving ≥2-point Decrease From Baseline in Hidradenitis Suppurativa - Investigator's Global Assessment (HS-IGA) at Week 16(Week 16)
- Change From Baseline in Draining Tunnel Count at Week 16(Baseline and Week 16)
- Percentage of Participants Remaining Free from HS Flare by Week 16(Week 16)
- Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving IHS4-55 at Week 16(Week 16)
- Change From Baseline on Dermatology Life Quality Index (DLQI) Global Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Numeric Rating Scale 30 (NRS30) at Week 16 with a Baseline NRS Score ≥3(Week 16)
- Number of Participants who Experienced at Least One Adverse Event (AE)(Up to Week 56)
- Plasma Concentration of Brensocatib(Pre-dose and at multiple timepoints post-dose up to Week 56)