A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248814
• Other study ID #: IM034-1014
• Secondary ID: 2022-502997-18
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• BMS-986326
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Czechia	Local Institution - 0009	Pardubice
France	CHU Estaing	Clermont-Ferrand
France	CHU de Nice - L'Archet	Nice
Germany	Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)	Berlin	BE
Germany	Local Institution - 0005	Chemnitz	SN
Germany	Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Exzellenzzentrum Entzuendungsmedizin	Lubeck	SH
Poland	Centrum Medyczne Pratia - Katowice	Katowice	SL
Poland	Malopolskie Centrum Kliniczne	Krakow	MA
Poland	Local Institution - 0001	Rzeszow	Podkarpackie
Spain	Hospital Universitario Reina Sofía	Córdoba	X
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria	GC

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to approximately 224 days
Primary	Number of participants with serious adverse events (SAEs)		Up to approximately 224 days
Primary	Number of participants with clinical laboratory abnormalities		Up to approximately 224 days
Primary	Number of participants with vital sign abnormalities		Up to approximately 224 days
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to approximately 224 days
Primary	Number of participants with physical examination abnormalities		Up to approximately 224 days
Secondary	Maximum observed concentration (Cmax)		Up to approximately 224 days
Secondary	Time of maximum observed concentration (Tmax)		Up to approximately 224 days
Secondary	Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]		Up to approximately 224 days
Secondary	Change from baseline in regulatory T cell (Treg) count		Up to approximately 224 days
Secondary	Change from baseline in Treg-to- conventional T cell (Tconv) ratio		Up to approximately 224 days
Secondary	Incidence of anti-drug antibody (ADA)		Up to approximately 224 days
Secondary	Mean percentage change from baseline at selected visits through 112 days in EASI score		Up to approximately 112 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting