A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT05014438
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment BMS-986166 Dose 2 BMS-986166 - Treatment BMS-986166 Dose 3 BMS-986166 - Placebo Placebo - Treatment BMS-986166 Dose 1 BMS-986166 - Treatment Branebrutinib Branebrutinib -
- Primary Outcome Measures
Name Time Method Mean Percentage Change From Baseline in EASI Score at Week 16 From baseline and 16 weeks 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16 From baseline and 16 weeks 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.Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16 From baseline and 16 weeks 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.Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16 From baseline and 16 weeks 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.Number of Participants With Clinically Relevant Changes in LFTs Week 24 after initial treatment 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 RatioPercentage 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 From baseline and 16 weeks 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.Mean Change From Baseline in Percentage of Affected BSA at Week 16 From baseline and 16 weeks 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.
Number of Participants With Mild Moderate or Severe SAEs From initial treatment to 30 days post discontinuation, approximately 29 weeks 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 eventNumber of Participants With Clinically Relevant ECG Abnormalities Week 24 after initial treatment 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.
Number of Participants With Clinically Meaningful Changes in Vital Signs Week 24 after initial treatment The following vital signs will be assessed: systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature.
Number of Participants With Mild Moderate or Severe AEs From initial treatment to 30 days post discontinuation, approximately 29 weeks 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.Number of Participants With Clinically Relevant PFT Abnormalities Week 24 after initial treatment 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).
Number of Participants With Clinically Relevant OCT Abnormalities Week 24 after initial treatment 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.
Trial Locations
- Locations (35)
Private Practice - Dr. Ralph von Kiedrowski
🇩🇪Selters, Germany
Local Institution - 0008
🇺🇸Skokie, Illinois, United States
Local Institution - 0078
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 0094
🇺🇸Pittsburgh, Pennsylvania, United States
Holdsworth House Medical Practice
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0091
🇺🇸Fremont, California, United States
Local Institution - 0112
🇺🇸Brandon, Florida, United States
Local Institution - 0051
🇺🇸Saint Joseph, Missouri, United States
Premier Dermatology
🇦🇺Kogarah, New South Wales, Australia
Local Institution - 0003
🇺🇸Morgantown, West Virginia, United States
Charité Universitaetsmedizin Berlin - Campus Mitte
🇩🇪Berlin, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien
🇩🇪Gera, Germany
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Poland
ETYKA Osrodek Badan Klinicznych
🇵🇱Olsztyn, Poland
KliFOs - Klinische Forschung Osnabrück
🇩🇪Osnabrück, Germany
Local Institution - 0130
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitario La Paz-UCICEC/DERMA
🇪🇸Madrid, Spain
Local Institution - 0006
🇺🇸Miami Lakes, Florida, United States
Dermatology and Skin Cancer Specialists, LLC
🇺🇸Rockville, Maryland, United States
Local Institution - 0081
🇺🇸Indianapolis, Indiana, United States
The University of Texas Health Science Center at Houston
🇺🇸Bellaire, Texas, United States
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
Westmead Hospital-Dermatology
🇦🇺Westmead, New South Wales, Australia
York Dermatology Clinic and Research Centre
🇨🇦Richmond Hill, Ontario, Canada
SIMa Recherche
🇨🇦Verdun, Quebec, Canada
Local Institution - 0034
🇩🇪Bochum, Germany
Universitätsklinikum Bonn-Studienzentrum Dermatologie
🇩🇪Bonn, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
🇪🇸Las, Spain
Hospital General Universitario de Alicante-Dermatology
🇪🇸Alicante, Spain
Local Institution - 0083
🇺🇸Louisville, Kentucky, United States
Local Institution
🇩🇪Munich, Germany
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0061
🇺🇸Coral Gables, Florida, United States
Local Institution - 0110
🇺🇸Margate, Florida, United States