NCT06248814
Completed
Phase 1
A 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
Overview
- Phase
- Phase 1
- Intervention
- BMS-986326
- Conditions
- Dermatitis, Atopic
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 64
- Locations
- 13
- Primary Endpoint
- Number of participants with clinical laboratory abnormalities
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, drug levels, drug effects, and impact on disease severity of BMS-986326 in participants with moderate-to-severe atopic dermatitis (AD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening
- •Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic therapy for control of disease
- •All the following must be present to confirm 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)
- •Validated Investigator Global Assessment for Atopic Dermatitis ≥ 3 (at Screening and Day 1)
- •Peak Pruritus Numerical Rating Scale ≥ 4 (at Screening)
Exclusion Criteria
- •Evidence of an active and/or concurrent inflammatory skin condition that would interfere with the Investigator or subject-driven evaluations of AD
- •Any major surgery within the last 30 days before the first dose of study intervention, or any surgery planned during the course of the study
- •Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
Placebo, followed by BMS-986326 Dose A or Dose B
Intervention: BMS-986326
Placebo, followed by BMS-986326 Dose A or Dose B
Intervention: Placebo
BMS-986326 Dose A, followed by Placebo
Intervention: BMS-986326
BMS-986326 Dose A, followed by Placebo
Intervention: Placebo
BMS-986326 Dose B, followed by Placebo
Intervention: BMS-986326
BMS-986326 Dose B, followed by Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with clinical laboratory abnormalities
Time Frame: Up to approximately 224 days
Number of participants with adverse events (AEs)
Time Frame: Up to approximately 224 days
Number of participants with vital sign abnormalities
Time Frame: Up to approximately 224 days
Number of participants with physical examination abnormalities
Time Frame: Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to approximately 224 days
Secondary Outcomes
- Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)](Up to approximately 224 days)
- Change from baseline in regulatory T cell (Treg) count(Up to approximately 224 days)
- Change from baseline in Treg-to- conventional T cell (Tconv) ratio(Up to approximately 224 days)
- Incidence of anti-drug antibody (ADA)(Up to approximately 224 days)
- Maximum observed concentration (Cmax)(Up to approximately 224 days)
- Time of maximum observed concentration (Tmax)(Up to approximately 224 days)
- Mean percentage change from baseline at selected visits through 112 days in EASI score(Up to approximately 112 days)
Study Sites (13)
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