NCT05014438已完成2 期
A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients With Moderate to Severe Atopic Dermatitis
Bristol-Myers Squibb35 个研究点 分布在 6 个国家目标入组 17 人开始时间: 2021年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 35
- 主要终点
- Mean Percentage Change From Baseline in EASI Score at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986166 and of branebrutinib, each versus placebo, for the treatment of participants with moderate to severe atopic dermatitis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening
- •Disease duration of at least 24 months since diagnosis by any criteria
- •Documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization, or inappropriateness of therapy due to side effects or safety risks leading to prior discontinuation
- •Application of fixed doses of an additive-free, basic bland emollient twice-daily for ≥ 7 days before baseline visit and for the duration of the study
排除标准
- •Any major illness/condition or evidence of an unstable clinical condition or local active infection/infectious illness that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study or interfere with the interpretation of study results
- •Clinically relevant cardiovascular conditions or pulmonary conditions
- •High likelihood - based on participant history, and investigator judgement - of requiring rescue therapy in < 4 weeks prior to randomization
- •Evidence of acute flare between the Screening and Baseline/ Randomization
- •Skin lesion(s) and/or pruritus due to conditions other than AD that would interfere with the study specified assessments
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Treatment BMS-986166 Dose 1
Experimental
干预措施: BMS-986166 (Drug)
Treatment BMS-986166 Dose 2
Experimental
干预措施: BMS-986166 (Drug)
Treatment BMS-986166 Dose 3
Experimental
干预措施: BMS-986166 (Drug)
Treatment Branebrutinib
Experimental
干预措施: Branebrutinib (Drug)
结局指标
主要结局
Mean Percentage Change From Baseline in EASI Score at Week 16
时间窗: From baseline and 16 weeks
The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
次要结局
- Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16(From baseline and 16 weeks)
- Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16(From baseline and 16 weeks)
- Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16(From baseline and 16 weeks)
- Number of Participants With Clinically Relevant Changes in LFTs(Week 24 after initial treatment)
- Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16(From baseline and 16 weeks)
- Mean Change From Baseline in Percentage of Affected BSA at Week 16(From baseline and 16 weeks)
- Number of Participants With Mild Moderate or Severe SAEs(From initial treatment to 30 days post discontinuation, approximately 29 weeks)
- Number of Participants With Clinically Relevant ECG Abnormalities(Week 24 after initial treatment)
- Number of Participants With Clinically Meaningful Changes in Vital Signs(Week 24 after initial treatment)
- Number of Participants With Mild Moderate or Severe AEs(From initial treatment to 30 days post discontinuation, approximately 29 weeks)
- Number of Participants With Clinically Relevant PFT Abnormalities(Week 24 after initial treatment)
- Number of Participants With Clinically Relevant OCT Abnormalities(Week 24 after initial treatment)
研究者
研究点 (35)
Loading locations...
相似试验
终止
2 期
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus NephritisLupus NephritisNCT03943147Bristol-Myers Squibb16
进行中（未招募）
2 期
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's DiseaseAlzheimer Disease, Early OnsetNCT06268886Bristol-Myers Squibb310
终止
2 期
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's DiseaseGranulomatous ColitisCrohn's EnteritisGranulomatous EnteritisCrohn's DiseaseNCT03599622Bristol-Myers Squibb239
已完成
1 期
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 AbsorptionHealthy ParticipantsNCT04926051Bristol-Myers Squibb40
进行中（未招募）
3 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisNCT06003426Bristol-Myers Squibb1,255