Phase 2
Completed N=17
A Study of BMS-986166 or Branebrutinib for the Treatment of Participants With Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT05014438 ↗
Enrolled (actual)
17
Serious AEs
5.9%
Results posted
Oct 2023
Primary outcomePrimary: Mean Percentage Change From Baseline in EASI Score at Week 16 — -83.1; -92.3 Percentage change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage Change From Baseline in EASI Score at Week 16 |
-83.1; -92.3 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Exhibiting a ≥ 50% (EASI-50) Reduction From Baseline in EASI Score at Week 16 |
25; 0; 0; 0; 33.3 | — |
| SECONDARY Percentage of Participants Exhibiting a ≥ 4-point Improvement From Baseline in Pruritus NRS at Week 16 |
25.0; 0; 0; 50; 50 | — |
| SECONDARY Mean Percentage Change From Baseline in Pruritus NRS Score at Week 16 |
-89.6; -100; -86.8 | — |
| SECONDARY Mean Change From Baseline in Percentage of Affected BSA at Week 16 |
-17.00; -12.10 | — |
| SECONDARY Number of Participants With Mild Moderate or Severe AEs |
1; 2; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants With Mild Moderate or Severe SAEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant ECG Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant OCT Abnormalities |
0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant PFT Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Meaningful Changes in Vital Signs |
2; 1; 2; 3; 3; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in LFTs |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05014438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.