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Clinical Trials/NCT05175352
NCT05175352CompletedPhase 1

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

Celgene12 sites in 1 country16 target enrollmentStarted: June 7, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Celgene
Enrollment
16
Locations
12
Primary Endpoint
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Experimental

Intervention: Cendakimab (Drug)

Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Experimental

Intervention: CYP substrates (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Up to 18 Weeks

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

Time Frame: Up to 18 Weeks

Secondary Outcomes

  • Pharmacokinetics - Maximum plasma concentration of drug (Cmax)(Up to 18 Weeks)
  • Relationship of TEAEs(Up to 34 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)

Investigators

Sponsor
Celgene
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

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