A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 20
- 主要终点
- Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
研究概览
简要总结
This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
详细描述
This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
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)
盲法说明
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved participant informed consent form prior to administration of any study-related procedures.
- •Participant must have stable HS.
- •Total abscesses and/or nodule (AN) count of ≥5 at Baseline visit.
- •HS lesions present in at least 2 distinct anatomical areas at Screening and Baseline.
排除标准
- •Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
- •Participant has an uncontrolled non-immunoinflammatory disease that may place the participant at increased risk during the study or impact the interpretation of results, e.g., previous malignancy, previous venous thromboembolism.
- •Participant has experience with >2 biologics, >1 Janus kinase (JAK) inhibitor, or a combination of 1 biologic experience and 1 JAK inhibitor.
- •Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the Screening visit.
研究组 & 干预措施
ATI-450
ATI-450 50 milligrams (mg) oral tablet twice daily (BID)
干预措施: ATI-450 (Drug)
Placebo
Placebo oral tablet BID
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
时间窗: Baseline, Week 12
AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.
次要结局
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12(Week 12)
- Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving NRS30(Week 12)
- Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HSPGA) at Week 12(Baseline, Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12(Baseline, Week 12)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline through Day 115)
- ATI-450 and Metabolite (CDD-2164) Concentrations(2 hours postdose on Days 1, 8, and 85)