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Completed

NCT Number: NCT05014438

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

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premier Dermatology, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986166

Drug

Specified dose on specified days

Branebrutinib

Drug

Specified dose on specified days

Other names: BMS-986195

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Mean Percentage Change From Baseline in EASI Score at Week 16

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16

    Time frame: 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.

  3. Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16

    Time frame: 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.

  4. Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16

    Time frame: 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.

  5. Mean Change From Baseline in Percentage of Affected BSA at Week 16

    Time frame: 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.

  6. Number of Participants With Mild Moderate or Severe AEs

    Time frame: 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.

  7. Number of Participants With Mild Moderate or Severe SAEs

    Time frame: 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 event

  8. Number of Participants With Clinically Relevant ECG Abnormalities

    Time frame: 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.

  9. Number of Participants With Clinically Relevant OCT Abnormalities

    Time frame: 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.

  10. Number of Participants With Clinically Relevant PFT Abnormalities

    Time frame: 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).

  11. Number of Participants With Clinically Meaningful Changes in Vital Signs

    Time frame: 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.

  12. Number of Participants With Clinically Relevant Changes in LFTs

    Time frame: 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 Ratio

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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