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

NCT ID: NCT05175352

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2024-10-11

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.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Keywords

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Eosinophilic Esophagitis Cendakimab Drug-drug interactions DDI

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Group Type EXPERIMENTAL

Cendakimab

Intervention Type DRUG

Specified dose on specified days

CYP substrates

Intervention Type DRUG

Specified dose on specified days

Interventions

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Cendakimab

Specified dose on specified days

Intervention Type DRUG

CYP substrates

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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CC-93538 BMS-986355

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 004

Tucson, Arizona, United States

Site Status

Local Institution - 001

Los Angeles, California, United States

Site Status

Local Institution - 022

San Diego, California, United States

Site Status

Local Institution - 016

Bristol, Connecticut, United States

Site Status

Local Institution - 002

Inverness, Florida, United States

Site Status

Local Institution - 010

Miami, Florida, United States

Site Status

Local Institution - 021

Plantation, Florida, United States

Site Status

Local Institution - 020

Gurnee, Illinois, United States

Site Status

Local Institution - 008

Iowa City, Iowa, United States

Site Status

Local Institution - 003

Albuquerque, New Mexico, United States

Site Status

Local Institution - 018

Durham, North Carolina, United States

Site Status

Local Institution - 012

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CC-93538-DDI-001

Identifier Type: -

Identifier Source: org_study_id