A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
NCT ID: NCT05014438
Last Updated: 2023-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2021-08-17
2022-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Specified dose on specified days
Treatment BMS-986166 Dose 1
BMS-986166
Specified dose on specified days
Treatment BMS-986166 Dose 2
BMS-986166
Specified dose on specified days
Treatment BMS-986166 Dose 3
BMS-986166
Specified dose on specified days
Treatment Branebrutinib
Branebrutinib
Specified dose on specified days
Interventions
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BMS-986166
Specified dose on specified days
Branebrutinib
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, , Germany
Local Institution
Berlin, , Germany
Local Institution - 0034
Bochum, , Germany
Universitätsklinikum Bonn-Studienzentrum Dermatologie
Bonn, , Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien
Gera, , Germany
Local Institution
Hanover, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Local Institution
Munich, , Germany
KliFOs - Klinische Forschung Osnabrück
Osnabrück, , Germany
Private Practice - Dr. Ralph von Kiedrowski
Selters, , Germany
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, , Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn, , Poland
Local Institution - 0130
Córdoba, Andalusia, Spain
Hospital General Universitario de Alicante-Dermatology
Alicante, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
Las, , Spain
Hospital Universitario La Paz-UCICEC/DERMA
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-004767-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1259-1220
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM018-005
Identifier Type: -
Identifier Source: org_study_id
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