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

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Other: Placebo; Drug: BMS-986166; Drug: Branebrutinib

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Dermatology
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital-Dermatology
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
• Austria
  • Linz, Austria, 4020
    • Local Institution
• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Local Institution
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre
  • Quebec
    • Verdun, Quebec, Canada, H4G 3E7
      • Sima Recherche
• Germany
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Berlin, Germany, 12459
    • Local Institution
  • Bochum, Germany, 44793
    • Local Institution - 0034
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn-Studienzentrum Dermatologie
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera-Zentrum für klinische Studien
  • Hannover, Germany, 30625
    • Local Institution
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig-Holstein
  • Munich, Germany, 80337
    • Local Institution
  • Osnabrück, Germany, 49074
    • Klifos - Klinische Forschung Osnabruck
  • Selters, Germany, 56242
    • Private Practice - Dr. Ralph von Kiedrowski
• Poland
  • Bydgoszcz, Poland, 85-231
    • NZOZ Centrum Medyczne KERmed
  • Olsztyn, Poland, 10-117
    • ETYKA Osrodek Badan Klinicznych
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-962
      • Royalderm Agnieszka Nawrocka
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante-Dermatology
  • Las, Spain, 35010
    • Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz-UCICEC/DERMA
  • Andalucía
    • Cordoba, Andalucía, Spain, 14004
      • Local Institution - 0130
• United States
  • California
    • Fremont, California, United States, 94538
      • Local Institution - 0091
  • Florida
    • Brandon, Florida, United States, 33511
      • Local Institution - 0112
    • Coral Gables, Florida, United States, 33134
      • Local Institution - 0061
    • Margate, Florida, United States, 33063
      • Local Institution - 0110
    • Miami Lakes, Florida, United States, 33014
      • Local Institution - 0006
    • Tampa, Florida, United States, 33613
      • Local Institution
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Local Institution - 0008
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Local Institution - 0081
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Local Institution - 0083
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology and Skin Cancer Specialists, LLC
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Local Institution - 0051
  • New York
    • New York, New York, United States, 10029
      • Local Institution
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Local Institution - 0078
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Institution - 0094
  • Texas
    • Bellaire, Texas, United States, 77401
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78213
      • Local Institution
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Local Institution - 0003

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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 Names: BMS-986195

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Change From Baseline in EASI Score at Week 16	The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.	From baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The vIGA-AD is a static 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, and oozing/crusting (lichenification excluded). The rating of cleared (0), almost cleared (1), mild (2), moderate (3), and severe (4) will be assessed.	From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16	The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.	From baseline and 16 weeks
Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16	Participants will complete a daily diary recording the intensity of their pruritus they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The lower the score the better.	From baseline and 16 weeks
Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16	Participants will complete a daily diary recording the intensity of their pruritus and the average quality of sleep they experienced during the preceding 24 hours. The intensity of pruritus will be assessed using a validated 11-point NRS, ranging from 0 ("no itching") to 10 ("the worst itching imaginable"). The quality of sleep will be assessed using a validated 11-point NRS ranging from 0 ("the best possible sleep") to 10 ("the worst possible sleep). The lower the score the better.	From baseline and 16 weeks
Mean Change From Baseline in Percentage of Affected BSA at Week 16	A widely used method of measuring Body Surface Area (BSA) involvement by AD, is the rule of nines in which for each section of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], genitals [1%]) and will be reported as a percentage of all major body sections combined.	From baseline and 16 weeks
Number of Participants With Mild Moderate or Severe AEs	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. Mild: An event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities. Severe: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.	From initial treatment to 30 days post discontinuation, approximately 29 weeks
Number of Participants With Mild Moderate or Severe SAEs	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability; Is a congenital anomaly/birth defect.; Is an important medical event	From initial treatment to 30 days post discontinuation, approximately 29 weeks
Number of Participants With Clinically Relevant ECG Abnormalities	12 Lead Electrocardiogram (ECG). The participant will remain supine for 5 to 10 minutes prior to the ECG and must have lab work done after the tracing so that the ECG results remain as accurate as possible.	Week 24 after initial treatment
Number of Participants With Clinically Relevant OCT Abnormalities	Optical coherence tomography (OCT) is a non-invasive imaging test. It uses light waves to take cross-section pictures of your retina. Diagnosis is made by an ophthalmologist.	Week 24 after initial treatment
Number of Participants With Clinically Relevant PFT Abnormalities	Pulmonary function tests (PFT) include: forced expiratory volume (FEV1), percent predicted FEV1, forced vital capacity (FVC), percent predicted FVC, and Diffusion capacity of carbon monoxide (DLCO).	Week 24 after initial treatment
Number of Participants With Clinically Meaningful Changes in Vital Signs	The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature.	Week 24 after initial treatment
Number of Participants With Clinically Relevant Changes in LFTs	Liver Function Tests (LFTs) will include the following measurements: ALT OR AST > 3 X ULN; ALT OR AST > 5 X ULN; ALT OR AST > 8 X ULN; TOTAL BILIRUBIN > 2 X ULN; ALT OR AST > 3 X ULN AND (TOTAL BILIRUBIN > 2 X ULN OR INR >1.5) AST = aspartate aminotransferase ALT = alanine aminotransferase ULN = Upper limit number INR = International Normalized Ratio	Week 24 after initial treatment

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): August 22, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; BMS-986166; BMS-986195; Branebrutinib
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Branebrutinib
• Other Study ID Numbers: IM018-005; 2020-004767-77 (EudraCT Number); U1111-1259-1220 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No