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

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: Completed
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Drug: Cendakimab; Drug: CYP substrates

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Local Institution - 004
  • California
    • Los Angeles, California, United States, 90067
      • Local Institution - 001
    • San Diego, California, United States, 92103-5639
      • Local Institution - 022
  • Connecticut
    • Bristol, Connecticut, United States, 06010-5142
      • Local Institution - 016
  • Florida
    • Inverness, Florida, United States, 34452
      • Local Institution - 002
    • Miami, Florida, United States, 33144-2035
      • Local Institution - 010
    • Plantation, Florida, United States, 33324-3345
      • Local Institution - 021
  • Illinois
    • Gurnee, Illinois, United States, 60031-5711
      • Local Institution - 020
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Local Institution - 008
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-4725
      • Local Institution - 003
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Local Institution - 018
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Local Institution - 012

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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-∞)	Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)	Up to 18 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): October 11, 2024

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cendakimab; Eosinophilic Esophagitis; DDI; Drug-drug interactions
• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Eosinophilic Esophagitis
• 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