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

  • Clinicaltrials.gov identifier

    NCT05014438

  • Recruitment Status

    Recruiting

  • First Posted

    August 20, 2021

  • Last update posted

    August 20, 2021

Study Description

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.

  • Condition or Disease:Dermatitis, Atopic
  • Intervention/Treatment: Drug: BMS-986166
    Drug: Branebrutinib
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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
  • Estimated Study Start Date: August 2021
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: December 2022

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 16 [ Time Frame: At week 16 ]
  • Secondary Outcome Measures: 1. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 29 weeks ]
  • 2. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 29 weeks ]
  • 3. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 29 weeks ]
  • 4. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 29 weeks ]
  • 5. Proportion of participants exhibiting a vIGA-AD score of 0 (cleared) or 1 (almost cleared) plus a ≥ 2-point reduction from baseline at week 16 [ Time Frame: At week 16 ]
    Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD)
  • 6. Proportion of participants exhibiting a ≥ 50% Eczema Area and Severity Index (EASI-50) reduction from baseline EASI score at week 16 [ Time Frame: At week 16 ]
  • 7. Proportion of participants exhibiting a ≥ 4-point improvement from baseline in pruritus numerical rating scale (NRS) at week 16 [ Time Frame: At week 16 ]
  • 8. Mean percentage change from baseline in pruritus NRS score at week 16 [ Time Frame: At week 16 ]
  • 9. Mean change from baseline in percentage of affected body surface area (BSA) at week 16 [ Time Frame: At week 16 ]
  • 10. Incidence of all adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  • 11. Severity of all AEs [ Time Frame: Up to 24 weeks ]
    Severity will be measured by the following scale of intensity: Mild, Moderate, Severe
  • 12. Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 29 weeks ]
  • 13. Severity of all SAEs [ Time Frame: Up to 29 weeks ]
    Severity will be measured by the following scale of intensity: Mild, Moderate, Severe
  • 14. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 29 weeks ]
    PR interval: The time from the onset of the P wave to the start of the QRS complex
  • 15. Incidence of clinically significant changes in ECG parameters: QRS interval [ Time Frame: Up to 29 weeks ]
    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
  • 16. Incidence of clinically significant changes in ECG parameters: QT interval [ Time Frame: Up to 29 weeks ]
    QT interval: Measured from the beginning of the QRS complex to the end of the T wave
  • 17. Incidence of clinically significant changes in ECG parameters: QTcF interval [ Time Frame: Up to 29 weeks ]
    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
  • 18. Incidence of clinically significant changes in optical coherence tomography (OCT) [ Time Frame: Up to 29 weeks ]
  • 19. Incidence of clinically significant changes in pulmonary function tests (PFTs) [ Time Frame: Up to 29 weeks ]
  • 20. Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests [ Time Frame: Up to 29 weeks ]
  • 21. Incidence of clinically significant changes from baseline values in clinical laboratory results: Coagulation panel [ Time Frame: Up to 29 weeks ]
  • 22. Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 29 weeks ]
  • 23. Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 29 weeks ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
Los Angeles

United States, Florida
San Marcus Research Clinic, Inc.
Miami Lakes

United States, Illinois
Local Institution
Skokie

Australia, New South Wales
Local Institution
Kogarah

Australia, New South Wales
Local Institution
Sydney

Australia, New South Wales
Local Institution
Westmead

Australia, Victoria
Local Institution
East Melbourne

Austria
Local Institution
Linz

Canada, Alberta
Local Institution
Calgary

Canada, Ontario
Local Institution
London

Canada, Ontario
Local Institution
Markham

Germany
Local Institution
Berlin

Germany
Local Institution
Berlin

Germany
Local Institution
Bochum

Germany
Local Institution
Bonn

Germany
Local Institution
Dresden

Germany
Local Institution
Gera

Germany
Local Institution
Hannover

Germany
Local Institution
Kiel

Germany
Local Institution
Munich

Germany
Local Institution
Osnabrück

Germany
Local Institution
Selters

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Warsaw

Spain
Local Institution
Alicante

Spain
Local Institution
Barcelona

Spain
Local Institution
Las Palmas De GC

Spain
Local Institution
Madrid

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05014438 History of Changes
  • Other Study ID Numbers: IM018-005, 2020-004767-77, U1111-1259-1220
  • First Posted: August 20, 2021 Key Record Dates
  • Last Update Posted: August 20, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Atopic Dermatitis
    BMS-986166
    BMS-986195
    Branebrutinib
  • Additional relevant MeSH terms: Dermatitis, Atopic
    Dermatitis
    Eczema
    Skin Diseases
    Skin Diseases, Genetic
    Genetic Diseases, Inborn
    Skin Diseases, Eczematous
    Hypersensitivity, Immediate
    Hypersensitivity
    Immune System Diseases