Skip to main content
OpenTrials
Completed

NCT Number: NCT05175352

A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Eosinophilic Esophagitis Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 004, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cendakimab

Drug

Specified dose on specified days

Other names: CC-93538, BMS-986355

CYP substrates

Drug

Specified dose on specified days

Primary outcomes

  1. Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)

    Time frame: Up to 18 Weeks

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

    Time frame: Up to 18 Weeks

Secondary outcomes

  1. Pharmacokinetics - Maximum plasma concentration of drug (Cmax)

    Time frame: Up to 18 Weeks

  2. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 34 Weeks

  3. Severity of TEAEs

    Time frame: Up to 34 Weeks

  4. Relationship of TEAEs

    Time frame: Up to 34 Weeks

  5. Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time

    Time frame: Up to 34 Weeks

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 34 weeks

  7. Number of participants with electrocardiogram abnormalities

    Time frame: Up to 34 weeks

  8. Number of participants with vital sign abnormalities

    Time frame: Up to 34 weeks

  9. Number of participants with physical examination sign abnormalities

    Time frame: Up to 34 weeks

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.