The trial is taking place at:
P

Peak Gastroenterology Associates | Peak Gastro Colorado Springs

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

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Celgene

Status and phase

Enrolling
Phase 1

Conditions

Eosinophilic Esophagitis

Treatments

Drug: CYP substrates
Drug: Cendakimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05175352
CC-93538-DDI-001

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

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

Trial contacts and locations

22

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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