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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 : August 20, 2021
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
Estimated Study Start Date : August 16, 2021
Estimated Primary Completion Date : October 23, 2022
Estimated Study Completion Date : December 3, 2022

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


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: 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
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United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90045
Contact: Site 0002         
United States, Florida
San Marcus Research Clinic, Inc. Recruiting
Miami Lakes, Florida, United States, 33014
Contact: IDALIA ACOSTA, Site 0006    305-424-7420      
United States, Illinois
Local Institution Not yet recruiting
Skokie, Illinois, United States, 60077
Contact: Site 0008         
Australia, New South Wales
Local Institution Not yet recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Site 0063         
Local Institution Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact: Site 0060         
Local Institution Not yet recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0050         
Australia, Victoria
Local Institution Not yet recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Site 0046         
Austria
Local Institution Not yet recruiting
Linz, Austria, 4020
Contact: Site 0039         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2J 7E1
Contact: Site 0057         
Canada, Ontario
Local Institution Not yet recruiting
London, Ontario, Canada, N6A 3H7
Contact: Site 0026         
Local Institution Not yet recruiting
Markham, Ontario, Canada, L3P 1X2
Contact: Site 0028         
Germany
Local Institution Not yet recruiting
Berlin, Germany, 10117
Contact: Site 0014         
Local Institution Not yet recruiting
Berlin, Germany, 12459
Contact: Site 0055         
Local Institution Not yet recruiting
Bochum, Germany, 44793
Contact: Site 0034         
Local Institution Not yet recruiting
Bonn, Germany, 53127
Contact: Site 0030         
Local Institution Not yet recruiting
Dresden, Germany, 01097
Contact: Site 0012         
Local Institution Not yet recruiting
Gera, Germany, 07548
Contact: Site 0016         
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0053         
Local Institution Not yet recruiting
Kiel, Germany, 24105
Contact: Site 0031         
Local Institution Not yet recruiting
Munich, Germany, 80337
Contact: Site 0011         
Local Institution Not yet recruiting
Osnabrück, Germany, 49074
Contact: Site 0013         
Local Institution Not yet recruiting
Selters, Germany, 56242
Contact: Site 0035         
Poland
Local Institution Not yet recruiting
Bydgoszcz, Poland, 85-231
Contact: Site 0054         
Local Institution Not yet recruiting
Warsaw, Poland, 02-962
Contact: Site 0056         
Spain
Local Institution Not yet recruiting
Alicante, Spain, 03010
Contact: Site 0044         
Local Institution Not yet recruiting
Barcelona, Spain, 8041
Contact: Site 0033         
Local Institution Not yet recruiting
Las Palmas De GC, Spain, 35019
Contact: Site 0043         
Local Institution Not yet recruiting
Madrid, Spain, 28034
Contact: Site 0042         
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: August 20, 2021
Last Verified: August 2021

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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