close-icon

Log In to Bolder Science

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

By completing and submitting this form, you agree to allow Bolder Science to collect the information provided and to receive communications from Bolder Science in the future regarding disease education and research updates.

close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT05014438

  • Recruitment Status

    Active, not recruiting

  • First Posted

    August 20, 2021

  • Last update posted

    September 29, 2022

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: Other: Placebo
    Drug: BMS-986166
    Drug: Branebrutinib
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 17 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
  • Actual Study Start Date: August 2021
  • Estimated Primary Completion Date: August 2022
  • Actual Study Completion Date: January 2024

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 all adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  • 2. Mean change from baseline in percentage of affected body surface area (BSA) at week 16 [ Time Frame: At week 16 ]
  • 3. Mean percentage change from baseline in pruritus NRS score at week 16 [ Time Frame: At week 16 ]
  • 4. 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)
  • 5. 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 ]
  • 6. Proportion of participants exhibiting a ≥ 4-point improvement from baseline in pruritus numerical rating scale (NRS) at week 16 [ Time Frame: At week 16 ]
  • 7. Severity of all AEs [ Time Frame: Up to 24 weeks ]
    Severity will be measured by the following scale of intensity: Mild, Moderate, Severe
  • 8. Incidence of all serious adverse events (SAEs) [ Time Frame: Up to 29 weeks ]
  • 9. Severity of all SAEs [ Time Frame: Up to 29 weeks ]
    Severity will be measured by the following scale of intensity: Mild, Moderate, Severe
  • 10. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 29 weeks ]
  • 11. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 29 weeks ]
  • 12. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 29 weeks ]
  • 13. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 29 weeks ]
  • 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

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

Locations

United States, California
Local Institution - 0091
Fremont

United States, Florida
Local Institution - 0061
Coral Gables

United States, Florida
Local Institution - 0110
Margate

United States, Florida
Local Institution - 0006
Miami Lakes

United States, Florida
Local Institution - 0112
Tampa

United States, Florida
Local Institution
Tampa

United States, Illinois
Local Institution - 0008
Skokie

United States, Indiana
Local Institution - 0081
Indianapolis

United States, Kentucky
Local Institution - 0083
Louisville

United States, Missouri
Local Institution - 0051
Saint Joseph

United States, New York
Local Institution
New York

United States, Pennsylvania
Local Institution - 0078
Philadelphia

United States, Pennsylvania
Local Institution - 0094
Pittsburgh

United States, Texas
Local Institution
San Antonio

United States, West Virginia
Local Institution - 0003
Morgantown

Australia, New South Wales
Local Institution - 0063
Kogarah

Australia, New South Wales
Holdsworth House Medical Practice
Sydney

Australia, New South Wales
Westmead Hospital-Dermatology
Westmead

Australia, Victoria
Sinclair Dermatology
East Melbourne

Austria
Local Institution
Linz

Canada, Ontario
Local Institution
Markham

Canada, Ontario
York Dermatology Clinic and Research Centre
Richmond Hill

Canada, Quebec
SIMa Recherche
Verdun

Germany
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
Hannover

Germany
Local Institution - 0031
Kiel

Germany
Local Institution
Munich

Germany
KliFOs - Klinische Forschung Osnabrück
Osnabrück

Germany
Private Practice - Dr. Ralph von Kiedrowski
Selters

Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz

Poland
Local Institution
Olsztyn

Poland
Royalderm Agnieszka Nawrocka
Warszaw

Spain, Andalucía
Local Institution - 0130
Cordoba

Spain
Hospital General Universitario de Alicante-Dermatology
Alicante

Spain
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
Las

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: September 29, 2022
  • Last Verified: September 2022
  • 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