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

Primary Purpose

Eosinophilic Esophagitis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cendakimab
CYP substrates
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Del Sol Research ManagementRecruiting
  • GastroIntestinal BiosciencesRecruiting
  • SDG Clinical Research, Inc.
  • Peak Gastroenterology Associates
  • Connecticut Gastroenterology InstituteRecruiting
  • Nature Coast Clinical Research LLCRecruiting
  • Homestead Associates in Research Inc
  • A Plus Research IncRecruiting
  • Asthma, Allergy Care Center of FloridaRecruiting
  • Illinois Gastroenterology Group- Gurnee (GI Allian
  • University Of Iowa Hospitals And ClinicsRecruiting
  • University Of Kansas Medical Center
  • University Of Louisville
  • New Mexico Clinical Research and Osteoporosis CenterRecruiting
  • Columbia Presbyterian Medical Center (Cpmc)
  • SUNY Upstate Medical University
  • Duke University Medical Center
  • Duke University Medical CenterRecruiting
  • Optimed Research LtdRecruiting
  • Vanderbilt University Medical Center
  • Houston Endoscopy and Research Center
  • University of Utah Health Care
  • McGuire Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)

Secondary Outcome Measures

Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Severity of TEAEs
Relationship of TEAEs
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram abnormalities
Number of participants with vital sign abnormalities
Number of participants with physical examination sign abnormalities

Full Information

First Posted
December 14, 2021
Last Updated
October 13, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT05175352
Brief Title
A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
April 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cendakimab
Other Intervention Name(s)
CC-93538, BMS-986355
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
CYP substrates
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Time Frame
Up to 18 Weeks
Title
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Time Frame
Up to 18 Weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame
Up to 18 Weeks
Title
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to 34 Weeks
Title
Severity of TEAEs
Time Frame
Up to 34 Weeks
Title
Relationship of TEAEs
Time Frame
Up to 34 Weeks
Title
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Time Frame
Up to 34 Weeks
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 34 weeks
Title
Number of participants with electrocardiogram abnormalities
Time Frame
Up to 34 weeks
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 34 weeks
Title
Number of participants with physical examination sign abnormalities
Time Frame
Up to 34 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Del Sol Research Management
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassel Kisso, Site 004
Phone
520-318-1236
Facility Name
GastroIntestinal Biosciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Karyotakis, Site 001
Phone
310-766-2079
Facility Name
SDG Clinical Research, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103-5639
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajiv Chandradas, Site 022
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Individual Site Status
Withdrawn
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010-5142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salam Zakko, Site 016
Phone
860-585-3838
Facility Name
Nature Coast Clinical Research LLC
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddharth Mathur, Site 002
Phone
352-341-2100
Facility Name
Homestead Associates in Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Withdrawn
Facility Name
A Plus Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33144-2035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Ramos, Site 010
Phone
523-618-9362
Facility Name
Asthma, Allergy Care Center of Florida
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324-3345
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahnaz Fatteh, Site 021
Phone
954-723-0334
Facility Name
Illinois Gastroenterology Group- Gurnee (GI Allian
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031-5711
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenberg, Site 020
Phone
847-244-2960
Facility Name
University Of Iowa Hospitals And Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami El Abiad, Site 008
Facility Name
University Of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Withdrawn
Facility Name
New Mexico Clinical Research and Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-4725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Rudolph, Site 003
Phone
505-855-5505
Facility Name
Columbia Presbyterian Medical Center (Cpmc)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Withdrawn
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Withdrawn
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Withdrawn
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Leiman, Site 018
Phone
919-668-7924
Facility Name
Optimed Research Ltd
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald McNeil, Site 012
Phone
614-505-3030
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Individual Site Status
Withdrawn
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Utah Health Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Withdrawn
Facility Name
McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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