NCT06248814已完成1 期
A Phase 1b, Randomized, Double-blind, Placebo-controlled, Single Dose, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 at Two Dose Levels in Adult Participants With Atopic Dermatitis
Bristol-Myers Squibb13 个研究点 分布在 5 个国家目标入组 64 人开始时间: 2024年3月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 13
- 主要终点
- Number of participants with clinical laboratory abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
- •Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease
- •All the following must be present to confirm moderate-to-severe AD
- •Eczema Area and Severity Index score ≥ 12 (at Screening and Day 1)
- •Body Surface Area ≥ 10% (at Screening and Day 1)
- •Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1)
- •Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)
排除标准
- •Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
- •Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study
- •Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo, followed by BMS-986326 Dose A or Dose B
Experimental
干预措施: BMS-986326 (Drug)
Placebo, followed by BMS-986326 Dose A or Dose B
Experimental
干预措施: Placebo (Other)
BMS-986326 Dose A, followed by Placebo
Experimental
干预措施: BMS-986326 (Drug)
BMS-986326 Dose A, followed by Placebo
Experimental
干预措施: Placebo (Other)
BMS-986326 Dose B, followed by Placebo
Experimental
干预措施: BMS-986326 (Drug)
BMS-986326 Dose B, followed by Placebo
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with clinical laboratory abnormalities
时间窗: Up to approximately 224 days
Number of participants with adverse events (AEs)
时间窗: Up to approximately 224 days
Number of participants with vital sign abnormalities
时间窗: Up to approximately 224 days
Number of participants with physical examination abnormalities
时间窗: Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
时间窗: Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to approximately 224 days
次要结局
- Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)](Up to approximately 224 days)
- Change from baseline in regulatory T cell (Treg) count(Up to approximately 224 days)
- Change from baseline in Treg-to- conventional T cell (Tconv) ratio(Up to approximately 224 days)
- Incidence of anti-drug antibody (ADA)(Up to approximately 224 days)
- Maximum observed concentration (Cmax)(Up to approximately 224 days)
- Time of maximum observed concentration (Tmax)(Up to approximately 224 days)
- Mean percentage change from baseline at selected visits through 112 days in EASI score(Up to approximately 112 days)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy ParticipantsHealthy ParticipantsNCT04882150Bristol-Myers Squibb102
已完成
1 期
A Phase 1 Dose Escalation Study of VX-973 in Healthy AdultsPainNCT05866055Vertex Pharmaceuticals Incorporated30
已完成
1 期
A Phase 1 Dose Escalation Study of Oral VX-708 in Healthy ParticipantsAcute PainNCT05347394Vertex Pharmaceuticals Incorporated100
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy VolunteersHealthy VolunteersNCT06625541AnnJi Pharmaceutical Co., Ltd.57
已完成
1 期
Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich AtaxiaFriedreich AtaxiaNCT05573698Design Therapeutics, Inc.32