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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

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-75
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not 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

Inclusion Criteria Icon img
:
  • 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
    1. Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE
      1. EoE symptoms documented in daily diary during the screening period

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • On a regimen of therapeutic anticoagulation
          1. Demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
            1. Currently receiving a high potency topical corticosteroid for dermatologic use Other protocol-defined inclusion/exclusion criteria apply
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

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

              ASSIGNED INTERVENTION
              • Drug: Cendakimab, CYP substrates

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