Overview

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

Status:
Not yet recruiting
Trial end date:
2024-01-11
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celgene
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

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