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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05175352
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis
Study Website: View Trial Website
Arms & Interventions

Arms

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

Interventions

Drug: - Cendakimab

Specified dose on specified days

Drug: - CYP substrates

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Not yet recruiting

Address

Northwest Allied Physicians LLC & Del Sol Research (SMO)

Tucson, Arizona, 85712

Gastrointestinal Biosciences, Los Angeles, California

Status

Not yet recruiting

Address

Gastrointestinal Biosciences

Los Angeles, California, 90067

Peak Gastroenterology Associates, Colorado Springs, Colorado

Status

Not yet recruiting

Address

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80920

Connecticut Gastroenterology Institute, Bristol, Connecticut

Status

Not yet recruiting

Address

Connecticut Gastroenterology Institute

Bristol, Connecticut, 06010-5142

Nature Coast Clinical Research LLC, Inverness, Florida

Status

Not yet recruiting

Address

Nature Coast Clinical Research LLC

Inverness, Florida, 34452

Nature Coast Clinical Research LLC, Inverness, Florida

Status

Recruiting

Address

Nature Coast Clinical Research LLC

Inverness, Florida, 34452

Site Contact

Siddharth Mathur, Site 002

Clinical.Trials@bms.com

352-341-2100

Homestead Associates in Research Inc, Miami, Florida

Status

Not yet recruiting

Address

Homestead Associates in Research Inc

Miami, Florida, 33032

A Plus Research Inc, Miami, Florida

Status

Not yet recruiting

Address

A Plus Research Inc

Miami, Florida, 33144-2035

University Of Iowa Hospitals And Clinics, Iowa City, Iowa

Status

Not yet recruiting

Address

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Westwood, Kansas

Status

Not yet recruiting

Address

University of Kansas Medical Center

Westwood, Kansas, 66205

University of Louisville, Louisville, Kentucky

Status

Not yet recruiting

Address

University of Louisville

Louisville, Kentucky, 40202

Albuquerque, New Mexico

Status

Not yet recruiting

Address

New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106-4725

Albuquerque, New Mexico

Status

Recruiting

Address

New Mexico Clinical Research and Osteoporosis Center

Albuquerque, New Mexico, 87106-4725

Site Contact

Lance Rudolph, Site 003

Clinical.Trials@bms.com

505-855-5505

SUNY Upstate Medical University, Syracuse, New York

Status

Not yet recruiting

Address

SUNY Upstate Medical University

Syracuse, New York, 13210

Duke University Medical Center, Durham, North Carolina

Status

Withdrawn

Address

Duke University Medical Center

Durham, North Carolina, 27710

Optimed Research Ltd, Columbus, Ohio

Status

Not yet recruiting

Address

Optimed Research Ltd

Columbus, Ohio, 43235

Houston Endoscopy and Research Center, Houston, Texas

Status

Not yet recruiting

Address

Houston Endoscopy and Research Center

Houston, Texas, 77079

University of Utah Health Care, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah Health Care

Salt Lake City, Utah, 84132

McGuire Veterans Affairs Medical Center, Richmond, Virginia

Status

Not yet recruiting

Address

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249

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