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

February 15, 2024 updated by: Celgene

A Phase 1, Open-label, Single-sequence Study to Evaluate Potential Disease-mediated Drug-drug Interaction With Selected Cytochrome P450 Substrates in Adult Subjects With Active Eosinophilic Esophagitis Receiving Cendakimab

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management
        • Contact:
          • Bassel Kisso, Site 004
          • Phone Number: 520-318-1236
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • GastroIntestinal BioSciences
        • Contact:
          • Nicholas Karyotakis, Site 001
          • Phone Number: 310-766-2079
      • San Diego, California, United States, 92103-5639
        • Recruiting
        • SDG Clinical Research, Inc.
        • Contact:
          • Sajiv Chandradas, Site 022
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Withdrawn
        • Peak Gastroenterology Associates
    • Connecticut
      • Bristol, Connecticut, United States, 06010-5142
        • Recruiting
        • Connecticut Gastroenterology Institute
        • Contact:
          • Salam Zakko, Site 016
          • Phone Number: 860-585-3838
    • Florida
      • Inverness, Florida, United States, 34452
        • Recruiting
        • Nature Coast Clinical Research LLC
        • Contact:
          • Siddharth Mathur, Site 002
          • Phone Number: 352-341-2100
      • Miami, Florida, United States, 33032
        • Withdrawn
        • Homestead Associates in Research Inc
      • Miami, Florida, United States, 33144-2035
        • Recruiting
        • A Plus Research Inc
        • Contact:
          • Carlos Ramos, Site 010
          • Phone Number: 523-618-9362
      • Plantation, Florida, United States, 33324-3345
        • Recruiting
        • Asthma, Allergy Care Center of Florida
        • Contact:
          • Shahnaz Fatteh, Site 021
          • Phone Number: 954-723-0334
    • Illinois
      • Gurnee, Illinois, United States, 60031-5711
        • Recruiting
        • Illinois Gastroenterology Group- Gurnee (GI Allian
        • Contact:
          • Jonathan Rosenberg, Site 020
          • Phone Number: 847-244-2960
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Rami El Abiad, Site 008
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Withdrawn
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Withdrawn
        • University of Louisville
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4725
        • Recruiting
        • New Mexico Clinical Research and Osteoporosis Center
        • Contact:
          • Lance Rudolph, Site 003
          • Phone Number: 505-855-5505
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia Presbyterian Medical Center (Cpmc)
      • Syracuse, New York, United States, 13210
        • Withdrawn
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • David Leiman, Site 018
          • Phone Number: 919-668-7924
      • Durham, North Carolina, United States, 27710
        • Withdrawn
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Recruiting
        • Optimed Research Ltd
        • Contact:
          • Donald McNeil, Site 012
          • Phone Number: 614-505-3030
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Withdrawn
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77079
        • Withdrawn
        • Houston Endoscopy and Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Withdrawn
        • University of Utah Health Care
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Withdrawn
        • McGuire Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Drug: Cendakimab
Specified dose on specified days
Other Names:
  • BMS-986355
  • CC-93538
Drug: CYP substrates
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Time Frame: Up to 18 Weeks
Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Time Frame: Up to 18 Weeks
Up to 18 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame: Up to 18 Weeks
Up to 18 Weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 34 Weeks
Up to 34 Weeks
Severity of TEAEs
Time Frame: Up to 34 Weeks
Up to 34 Weeks
Relationship of TEAEs
Time Frame: Up to 34 Weeks
Up to 34 Weeks
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Time Frame: Up to 34 Weeks
Up to 34 Weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 34 weeks
Up to 34 weeks
Number of participants with electrocardiogram abnormalities
Time Frame: Up to 34 weeks
Up to 34 weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 34 weeks
Up to 34 weeks
Number of participants with physical examination sign abnormalities
Time Frame: Up to 34 weeks
Up to 34 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

January 25, 2025

Study Completion (Estimated)

January 25, 2025

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-93538-DDI-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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