Clinical trial NCT06248814: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Dermatitis, Atopic
Keywords: Skin Disease
Dermatitis
Eczema
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 224 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to approximately 224 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 224 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 224 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to approximately 224 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to approximately 224 days
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to approximately 224 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to approximately 224 days
measure: Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to approximately 224 days
measure: Change from baseline in regulatory T cell (Treg) count
timeFrame: Up to approximately 224 days
measure: Change from baseline in Treg-to- conventional T cell (Tconv) ratio
timeFrame: Up to approximately 224 days
measure: Incidence of anti-drug antibody (ADA)
timeFrame: Up to approximately 224 days
measure: Mean percentage change from baseline at selected visits through 112 days in EASI score
timeFrame: Up to approximately 112 days
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Local Institution - 0004
state: PR
city: Pardubice
country: Czechia
facility: Local Institution - 0009
city: Clermont-Ferrand
country: France
facility: Local Institution - 0006
city: Nice
country: France
facility: Local Institution - 0010
city: Pierre Benite
country: France
facility: Local Institution - 0008
city: Berlin
country: Germany
facility: Local Institution - 0011
state: BE
city: Lubeck
country: Germany
facility: Local Institution - 0012
state: SH
city: Chemnitz
country: Germany
facility: Local Institution - 0005
state: SN
city: Krakow
country: Poland
facility: Local Institution - 0015
state: MA
city: Rzeszow
country: Poland
facility: Local Institution - 0001
state: Podkarpackie
city: Katowice
country: Poland
facility: Local Institution - 0016
state: SL
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 0013
state: GC
city: Córdoba
country: Spain
facility: Local Institution - 0002
state: X
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: