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NCT05175352 Clinical Trial

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

Eosinophilic Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05175352
Other study ID # CC-93538-DDI-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 7, 2022
Est. completion date January 25, 2025

Study information
Verified date February 2024
Source Celgene
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date January 25, 2025
Est. primary completion date January 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cendakimab
Specified dose on specified days
• CYP substrates
Specified dose on specified days

Locations
Country Name City State
United States New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico
United States Connecticut Gastroenterology Institute Bristol Connecticut
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Optimed Research Ltd Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States Duke University Medical Center Durham North Carolina
United States Illinois Gastroenterology Group- Gurnee (GI Allian Gurnee Illinois
United States Houston Endoscopy and Research Center Houston Texas
United States Nature Coast Clinical Research LLC Inverness Florida
United States University Of Iowa Hospitals And Clinics Iowa City Iowa
United States GastroIntestinal Biosciences Los Angeles California
United States University Of Louisville Louisville Kentucky
United States A Plus Research Inc Miami Florida
United States Homestead Associates in Research Inc Miami Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia Presbyterian Medical Center (Cpmc) New York New York
United States Asthma, Allergy Care Center of Florida Plantation Florida
United States McGuire Veterans Affairs Medical Center Richmond Virginia
United States University of Utah Health Care Salt Lake City Utah
United States SDG Clinical Research, Inc. San Diego California
United States SUNY Upstate Medical University Syracuse New York
United States Del Sol Research Management Tucson Arizona
United States University Of Kansas Medical Center Westwood Kansas

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-8) Up to 18 Weeks
Primary Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h) Up to 18 Weeks
Secondary Pharmacokinetics - Maximum plasma concentration of drug (Cmax) Up to 18 Weeks
Secondary Incidence of Treatment-Emergent Adverse Events (TEAEs) Up to 34 Weeks
Secondary Severity of TEAEs Up to 34 Weeks
Secondary Relationship of TEAEs Up to 34 Weeks
Secondary Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time Up to 34 Weeks
Secondary Number of participants with clinical laboratory abnormalities Up to 34 weeks
Secondary Number of participants with electrocardiogram abnormalities Up to 34 weeks
Secondary Number of participants with vital sign abnormalities Up to 34 weeks
Secondary Number of participants with physical examination sign abnormalities Up to 34 weeks
See also
  Status Clinical Trial Phase
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Completed NCT05083312 - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial Phase 3
Completed NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Completed NCT03633617 - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) Phase 3
Completed NCT04941742 - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated NCT04543409 - A Study of Benralizumab in Patients With Eosinophilic Esophagitis Phase 3
Terminated NCT02314455 - Esophageal Absorption in EoE N/A
Completed NCT01953575 - Mucosal Impedance and Eosinophilic Esophagitis N/A
Completed NCT01386112 - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis Phase 1/Phase 2
Recruiting NCT04991935 - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis Phase 3
Not yet recruiting NCT05896891 - San Raffaele EoE Biobank
Active, not recruiting NCT05482256 - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis N/A
Recruiting NCT05485155 - Zemaira Eosinophilic Esophagitis Pilot Study Phase 2
Recruiting NCT04149470 - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) Phase 4
Recruiting NCT04416217 - Eosinophilic Esophagitis Steroid Safety Study
Completed NCT05084963 - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis Phase 2
Completed NCT02579876 - Milk Patch for Eosinophilic Esophagitis Phase 2
Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population

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