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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID: NCT05014438
Run by: Bristol-Myers Squibb
People needed: 17
Starts: 2021-08-17
Expected to finish: 2022-08-22
Last updated by the study team: 2023-10-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Local Institution - 0091 — Fremont, California, United States
Local Institution - 0112 — Brandon, Florida, United States
Local Institution - 0061 — Coral Gables, Florida, United States
Local Institution - 0110 — Margate, Florida, United States
Local Institution - 0006 — Miami Lakes, Florida, United States
Local Institution — Tampa, Florida, United States
Local Institution - 0008 — Skokie, Illinois, United States
Local Institution - 0081 — Indianapolis, Indiana, United States
Local Institution - 0083 — Louisville, Kentucky, United States
Dermatology and Skin Cancer Specialists, LLC — Rockville, Maryland, United States
Local Institution - 0051 — Saint Joseph, Missouri, United States
Local Institution — New York, New York, United States
Local Institution - 0078 — Philadelphia, Pennsylvania, United States
Local Institution - 0094 — Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston — Bellaire, Texas, United States
Local Institution — San Antonio, Texas, United States
Local Institution - 0003 — Morgantown, West Virginia, United States
Premier Dermatology — Kogarah, New South Wales, Australia
Holdsworth House Medical Practice — Sydney, New South Wales, Australia
Westmead Hospital-Dermatology — Westmead, New South Wales, Australia
Sinclair Dermatology — East Melbourne, Victoria, Australia
Local Institution — Linz, Austria
Local Institution — Markham, Ontario, Canada
York Dermatology Clinic and Research Centre — Richmond Hill, Ontario, Canada
SIMa Recherche — Verdun, Quebec, Canada

Full record on ClinicalTrials.gov

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