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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05175352

Enrollment

Registered

2022-01-03

Start date

2022-06-07

Completion date

2024-10-11

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI

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.

Interventions

DRUGCendakimab

Specified dose on specified days

DRUGCYP substrates

Specified dose on specified days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

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

Measure	Time frame
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
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)	Up to 18 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
Number of participants with clinical laboratory abnormalities	Up to 34 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Up to 34 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026