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Recruiting

A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis - IM018-005

Updated: 16 August, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • 28

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Placebo Comparator: Placebo
Experimental: Treatment BMS-986166 Dose 1
Experimental: Treatment BMS-986166 Dose 2
Experimental: Treatment BMS-986166 Dose 3
Experimental: Treatment Branebrutinib

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com