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
Not provided
Not provided
Not provided
The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Cendakimab and Cytochrome P450 (CYP) substrates | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cendakimab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞) | Up to 18 Weeks | |
| Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h) | Up to 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Maximum plasma concentration of drug (Cmax) | Up to 18 Weeks | |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Up to 34 Weeks | |
| Severity of TEAEs |
Not provided
Inclusion Criteria:
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 - 004 | Tucson | Arizona | 85715 | United States | ||
| Local Institution - 001 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CYP substrates | Drug | Specified dose on specified days |
|
| Up to 34 Weeks |
| Relationship of TEAEs | Up to 34 Weeks |
| Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time | Up to 34 Weeks |
| Number of participants with clinical laboratory abnormalities | Up to 34 weeks |
| Number of participants with electrocardiogram abnormalities | Up to 34 weeks |
| Number of participants with vital sign abnormalities | Up to 34 weeks |
| Number of participants with physical examination sign abnormalities | Up to 34 weeks |
| Los Angeles |
| California |
| 90067 |
| United States |
| Local Institution - 022 | San Diego | California | 92103-5639 | United States |
| Local Institution - 016 | Bristol | Connecticut | 06010-5142 | United States |
| Local Institution - 002 | Inverness | Florida | 34452 | United States |
| Local Institution - 010 | Miami | Florida | 33144-2035 | United States |
| Local Institution - 021 | Plantation | Florida | 33324-3345 | United States |
| Local Institution - 020 | Gurnee | Illinois | 60031-5711 | United States |
| Local Institution - 008 | Iowa City | Iowa | 52242 | United States |
| Local Institution - 003 | Albuquerque | New Mexico | 87106-4725 | United States |
| Local Institution - 018 | Durham | North Carolina | 27710 | United States |
| Local Institution - 012 | Columbus | Ohio | 43235 | United States |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625155 | cendakimab |
Not provided
Not provided
Not provided