Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502997-18 | Registry Identifier | EU Trial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, followed by BMS-986326 Dose A or Dose B | Experimental |
| |
| BMS-986326 Dose A, followed by Placebo | Experimental |
| |
| BMS-986326 Dose B, followed by Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986326 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to approximately 224 days | |
| Number of participants with serious adverse events (SAEs) | Up to approximately 224 days | |
| Number of participants with clinical laboratory abnormalities | Up to approximately 224 days | |
| Number of participants with vital sign abnormalities | Up to approximately 224 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to approximately 224 days | |
| Number of participants with physical examination abnormalities | Up to approximately 224 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to approximately 224 days | |
| Time of maximum observed concentration (Tmax) | Up to approximately 224 days | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] |
Not provided
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
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0004 | Prague | PR | 100 00 | Czechia | ||
| Local Institution - 0009 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified dose on specified days |
|
| 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 |
| Mean percentage change from baseline at selected visits through 112 days in EASI score | Up to approximately 112 days |
| Pardubice |
| 530 02 |
| Czechia |
| Local Institution - 0006 | Clermont-Ferrand | 63003 | France |
| Local Institution - 0010 | Nice | 06200 | France |
| Local Institution - 0008 | Pierre-Bénite | 69495 | France |
| Local Institution - 0005 | Chemnitz | Saxony | 09117 | Germany |
| Local Institution - 0012 | Lübeck | Schleswig-Holstein | 23562 | Germany |
| Local Institution - 0011 | Berlin | State of Berlin | 10117 | Germany |
| Local Institution - 0015 | Krakow | Lesser Poland Voivodeship | 30-149 | Poland |
| Local Institution - 0001 | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Local Institution - 0016 | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Local Institution - 0013 | Las Palmas de Gran Canaria | GC | 35010 | Spain |
| Local Institution - 0002 | Córdoba | X | 14004 | Spain |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D012871 | Skin Diseases |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided