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

Phase 1

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Cendakimab; Drug: CYP substrates

• Registration Number: NCT05175352
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Study Start: 2022-06-07
• Primary Completion: 2024-10-11
• Study Completion: 2024-10-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Cendakimab and Cytochrome P450 (CYP) substrates	Cendakimab	-
Administration of Cendakimab and Cytochrome P450 (CYP) substrates	CYP substrates	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

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

Local Institution - 016; 🇺🇸 Bristol, Connecticut, United States

Local Institution - 002; 🇺🇸 Inverness, Florida, United States

Local Institution - 010; 🇺🇸 Miami, Florida, United States

Local Institution - 021; 🇺🇸 Plantation, Florida, United States

Local Institution - 020; 🇺🇸 Gurnee, Illinois, United States

Local Institution - 008; 🇺🇸 Iowa City, Iowa, United States

Local Institution - 003; 🇺🇸 Albuquerque, New Mexico, United States

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