Study to assess the safety, tolerability, concentrations and drug effects of BMS-986326 in participants with atopic dermatitis
Topic / Pathology
- interventional
Objectives
Phase 1b, randomized, double-blind, placebo-controlled, single-dose, crossover study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BMS-986326 at two dose levels in adult participants with atopic dermatitis.
Randomized study with cross-over assignment. 3 arms:
- Placebo, followed by dose A or dose B of BMS-986326
- BMS-986326 dose A, followed by placebo
- BMS-986326 dose B, followed by placebo
https://clinicaltrials.gov/study/NCT06248814?term=NCT06248814%20&rank=1
Sponsor
Bristol-Myers Squibb
Investigator
Dr Thomas Hubiche
Critères d'inclusion
- Diagnosis of atopic dermatitis (AD) at least 12 months prior to selection.
- Documented history of inadequate response to topical treatment for at least 4 weeks, unless topical treatments are medically inadvisable, or having required systemic treatment to control the disease.
- All of the following must be present to confirm the presence of moderate to severe AD:
- Eczema Area and Severity Index score ≥ 12 (at screening and day 1)
- Body surface area ≥ 10% (at screening and day 1)
- Investigator-validated global assessment of atopic dermatitis ≥ 3 (at screening and day 1)
- Pruritus numerical rating scale ≥ 4 (at screening)
Critères de non-inclusion
- Evidence of active and/or concomitant inflammatory skin disease that would interfere with the investigator's or subject's assessment of AD.
- Any major surgery within 30 days prior to the first dose of the study procedure, or any planned surgery during the study.
- Any other valid medical, psychiatric and/or social reason, as determined by the investigator.
- Other protocol-defined inclusion/exclusion criteria apply.
Status
Ongoing
