A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label, Single-sequence Study to Evaluate Potential Disease-mediated Drug-drug Interaction With Selected Cytochrome P450 Substrates in Adult Subjects With Active Eosinophilic Esophagitis Receiving Cendakimab

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Drug: Cendakimab
* Drug: CYP substrates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Eosinophilic esophagitis (EoE) with histologic evidence as a peak count of ≥ 15 eosinophils per higher-power field at any 2 levels of the esophagus Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE EoE symptoms documented in daily diary during the screening period Exclusion Criteria: On a regimen of therapeutic anticoagulation Demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs Currently receiving a high potency topical corticosteroid for dermatologic use Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of Cendakimab and Cytochrome P450 (CYP) substrates<br> | Drug: Cendakimab<br>* Specified dose on specified days<br>* Other names: BMS-986355;Drug: CYP substrates<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI