Clinical trial NCT05014438: A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Official title: A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
BMS-986166
BMS-986195
Branebrutinib
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Percentage Change From Baseline in EASI Score at Week 16
timeFrame: From baseline and 16 weeks
Secondary outcomes:
measure: Percentage of Participants Exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 (Cleared) or 1 (Almost Cleared) AND a ≥ 2 Point Reduction From Baseline at Week 16
timeFrame: From baseline and 16 weeks
measure: Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16
timeFrame: From baseline and 16 weeks
measure: Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16
timeFrame: From baseline and 16 weeks
measure: Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16
timeFrame: From baseline and 16 weeks
measure: Mean Change From Baseline in Percentage of Affected BSA at Week 16
timeFrame: From baseline and 16 weeks
measure: Number of Participants With Mild Moderate or Severe AEs
timeFrame: From initial treatment to 30 days post discontinuation, approximately 29 weeks
measure: Number of Participants With Mild Moderate or Severe SAEs
timeFrame: From initial treatment to 30 days post discontinuation, approximately 29 weeks
measure: Number of Participants With Clinically Relevant ECG Abnormalities
timeFrame: Week 24 after initial treatment
measure: Number of Participants With Clinically Relevant OCT Abnormalities
timeFrame: Week 24 after initial treatment
measure: Number of Participants With Clinically Relevant PFT Abnormalities
timeFrame: Week 24 after initial treatment
measure: Number of Participants With Clinically Meaningful Changes in Vital Signs
timeFrame: Week 24 after initial treatment
measure: Number of Participants With Clinically Relevant Changes in LFTs
timeFrame: Week 24 after initial treatment
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Local Institution - 0091
state: California
city: Brandon
country: United States
facility: Local Institution - 0112
state: Florida
city: Coral Gables
country: United States
facility: Local Institution - 0061
state: Florida
city: Margate
country: United States
facility: Local Institution - 0110
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0006
state: Florida
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Skokie
country: United States
facility: Local Institution - 0008
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0081
state: Indiana
city: Louisville
country: United States
facility: Local Institution - 0083
state: Kentucky
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Saint Joseph
country: United States
facility: Local Institution - 0051
state: Missouri
city: New York
country: United States
facility: Local Institution
state: New York
city: Philadelphia
country: United States
facility: Local Institution - 0078
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0094
state: Pennsylvania
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Morgantown
country: United States
facility: Local Institution - 0003
state: West Virginia
city: Kogarah
country: Australia
facility: Premier Dermatology
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital-Dermatology
state: New South Wales
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Linz
country: Austria
facility: Local Institution
city: Markham
country: Canada
facility: Local Institution
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Verdun
country: Canada
facility: SIMa Recherche
state: Quebec
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte
city: Berlin
country: Germany
facility: Local Institution
city: Bochum
country: Germany
facility: Local Institution - 0034
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn-Studienzentrum Dermatologie
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien
city: Hannover
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Munich
country: Germany
facility: Local Institution
city: Osnabrück
country: Germany
facility: KliFOs - Klinische Forschung Osnabrück
city: Selters
country: Germany
facility: Private Practice - Dr. Ralph von Kiedrowski
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
city: Olsztyn
country: Poland
facility: ETYKA Osrodek Badan Klinicznych
city: Cordoba
country: Spain
facility: Local Institution - 0130
state: Andalucía
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante-Dermatology
city: Las
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-UCICEC/DERMA
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: