NCT05014438
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Dermatitis, Atopic
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 17
- Locations
- 35
- Primary Endpoint
- Mean Percentage Change From Baseline in EASI Score at Week 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Intervention: Placebo
Treatment BMS-986166 Dose 1
Intervention: BMS-986166
Treatment BMS-986166 Dose 2
Intervention: BMS-986166
Treatment BMS-986166 Dose 3
Intervention: BMS-986166
Treatment Branebrutinib
Intervention: Branebrutinib
Outcomes
Primary Outcomes
Mean Percentage Change From Baseline in EASI Score at Week 16
Time Frame: 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.
Secondary Outcomes
- 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)
Study Sites (35)
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