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

Celgene16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eosinophilic Esophagitis

Interventions

CendakimabDRUG

Specified dose on specified days

CYP substratesDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Local Institution - 004

Tucson, Arizona, United States

Local Institution - 001

Los Angeles, California, United States

Local Institution - 022

San Diego, California, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 18 Weeks

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

Pharmacokinetics - Maximum plasma concentration of drug (Cmax)

Time frame: Up to 18 Weeks

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to 34 Weeks

Severity of TEAEs

Time frame: Up to 34 Weeks

Relationship of TEAEs

Time frame: Up to 34 Weeks

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

Time frame: Up to 34 Weeks

Number of participants with clinical laboratory abnormalities

Time frame: Up to 34 weeks

Number of participants with electrocardiogram abnormalities

Time frame: Up to 34 weeks

Number of participants with vital sign abnormalities

Time frame: Up to 34 weeks

Number of participants with physical examination sign abnormalities

Data from ClinicalTrials.gov

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