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Trial ID CC-93538-DDI-001  |   NCT05175352

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-75
    Age Range
  • 10
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Administration of Cendakimab and Cytochrome P450 (CYP) substrates

ASSIGNED INTERVENTION
  • Drug: CYP substrates, Cendakimab
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