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Atopic Dermatitis (BMS-986166 Study)

Study Description

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

Dermatitis, Atopic

Study Design

Study Type: Interventional (Clinical Trial)
Actual 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
Actual Study Start Date: August 17, 2021
Actual Primary Completion Date: January 18, 2023
Actual Study Completion Date: February 28, 2023

Outcome Measures

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 ]

Eligibility Criteria

Ages Eligible for Study:   18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers: No

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 judgment – 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
ADDITIONAL DETAILS