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

Celgene

Status and phase: Active, not recruiting; Phase 1

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Cendakimab; Drug: CYP substrates

Study type: Interventional

Funder types: Industry

Identifiers

NCT05175352

CC-93538-DDI-001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Experimental group

Treatment:

Drug: CYP substrates

Drug: Cendakimab