A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis

  • End date
    Feb 28, 2023
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 27 July 2022
topical corticosteroid
topical agents


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.

Condition Dermatitis, Atopic
Treatment Placebo, BMS-986166, branebrutinib
Clinical Study IdentifierNCT05014438
SponsorBristol-Myers Squibb
Last Modified on27 July 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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