NCT05175352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2022

Typical duration for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

2.3 years

First QC Date

December 14, 2021

Last Update Submit

December 18, 2024

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic EsophagitisCendakimabDrug-drug interactionsDDI

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

EXPERIMENTAL
Drug: CendakimabDrug: CYP substrates

Interventions

CendakimabDRUG

Specified dose on specified days

Also known as: CC-93538, BMS-986355
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
CYP substratesDRUG

Specified dose on specified days

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Local Institution - 004

Tucson, Arizona, 85715, United States

Location

Local Institution - 001

Los Angeles, California, 90067, United States

Location

Local Institution - 022

San Diego, California, 92103-5639, United States

Location

Local Institution - 016

Bristol, Connecticut, 06010-5142, United States

Location

Local Institution - 002

Inverness, Florida, 34452, United States

Location

Local Institution - 010

Miami, Florida, 33144-2035, United States

Location

Local Institution - 021

Plantation, Florida, 33324-3345, United States

Location

Local Institution - 020

Gurnee, Illinois, 60031-5711, United States

Location

Local Institution - 008

Iowa City, Iowa, 52242, United States

Location

Local Institution - 003

Albuquerque, New Mexico, 87106-4725, United States

Location

Local Institution - 018

Durham, North Carolina, 27710, United States

Location

Local Institution - 012

Columbus, Ohio, 43235, United States

Location

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

cendakimab

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

June 7, 2022

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations

US(12)