NCT05014438
Recruiting
August 20, 2021
May 12, 2022
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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Treatment BMS-986166 Dose 1 |
Drug: BMS-986166 Specified dose on specified days |
Experimental: Treatment BMS-986166 Dose 2 |
Drug: BMS-986166 Specified dose on specified days |
Experimental: Treatment BMS-986166 Dose 3 |
Drug: BMS-986166 Specified dose on specified days |
Experimental: Treatment Branebrutinib |
Drug: Branebrutinib Specified dose on specified days |
Placebo Comparator: Placebo |
Other: Placebo Specified dose on specified days |
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
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Alabama
Local Institution
Birmingham
United States, California
Local Institution
Fremont
United States, California
Local Institution
Irvine
United States, California
Local Institution
Los Angeles
United States, California
Local Institution
Mission Viejo
United States, Florida
Local Institution
Brandon
United States, Florida
Driven Research
Coral Gables
United States, Florida
Local Institution
Margate
United States, Florida
San Marcus Research Clinic, Inc.
Miami Lakes
United States, Florida
Local Institution
Ormond Beach
United States, Florida
Local Institution
Tampa
United States, Georgia
Local Institution
Columbus
United States, Illinois
NorthShore University Health System-Dermatology Clinical Trials Unit
Skokie
United States, Indiana
Local Institution
Indianapolis
United States, Kentucky
Local Institution
Louisville
United States, Maryland
Local Institution
Rockville
United States, Missouri
MediSearch Clinical Trials
Saint Joseph
United States, New York
Local Institution
New York
United States, North Carolina
Local Institution
Wilmington
United States, Pennsylvania
Local Institution
Philadelphia
United States, Pennsylvania
Local Institution
Pittsburgh
United States, Texas
Local Institution
Houston
United States, Texas
Local Institution
San Antonio
United States, Texas
Local Institution
Sugar Land
United States, West Virginia
Local Institution
Morgantown
Australia, New South Wales
Local Institution - 0063
Kogarah
Australia, New South Wales
Local Institution - 0060
Sydney
Australia, New South Wales
Westmead Hospital-Dermatology
Westmead
Australia, Victoria
Sinclair Dermatology
East Melbourne
Austria
Local Institution
Linz
Canada, Alberta
Local Institution
Calgary
Canada, Ontario
Local Institution
London
Canada, Ontario
Local Institution
Markham
Canada, Ontario
York Dermatology Clinic and Research Centre
Richmond Hill
Canada, Quebec
Local Institution
Verdun, Communauté-Urbaine-de-Montréal
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin
Germany
Local Institution
Berlin
Germany
Local Institution - 0034
Bochum
Germany
Local Institution - 0030
Bonn
Germany
Local Institution
Dresden
Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien
Gera
Germany
Local Institution
Hannover
Germany
Local Institution - 0031
Kiel
Germany
Local Institution
Munich
Germany
KliFOs - Klinische Forschung Osnabrück
Osnabrück
Germany
Local Institution
Selters
Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz
Poland
Local Institution
Olsztyn
Poland
Royalderm Agnieszka Nawrocka
Warszaw
Spain
Hospital General Universitario de Alicante-Dermatology
Alicante
Spain
Local Institution
Barcelona
Spain
Local Institution
Las Palmas De GC
Spain
Local Institution
Madrid
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb