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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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.
Time frame: From baseline and 16 weeks
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Week 24 after initial treatment