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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014438
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Intervention/treatment Phase
Dermatitis, Atopic Drug: BMS-986166 Drug: Branebrutinib Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
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
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : January 18, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days

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
Other Name: BMS-986195




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. 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)

  2. 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 ]
  3. Proportion of participants exhibiting a ≥ 4-point improvement from baseline in pruritus numerical rating scale (NRS) at week 16 [ Time Frame: At week 16 ]
  4. Mean percentage change from baseline in pruritus NRS score at week 16 [ Time Frame: At week 16 ]
  5. Mean change from baseline in percentage of affected body surface area (BSA) at week 16 [ Time Frame: At week 16 ]
  6. Incidence of all adverse events (AEs) [ Time Frame: Up to 24 weeks ]
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014438


Contacts
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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 #.

Locations
Show Show 53 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05014438    
Other Study ID Numbers: IM018-005
2020-004767-77 ( EudraCT Number )
U1111-1259-1220 ( Registry Identifier: WHO )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

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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:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Branebrutinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action