Clinical trial NCT05175352: A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
Cendakimab
Drug-drug interactions
DDI
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2022-01-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
timeFrame: Up to 18 Weeks
measure: Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
timeFrame: Up to 18 Weeks
Secondary outcomes:
measure: Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
timeFrame: Up to 18 Weeks
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 34 Weeks
measure: Severity of TEAEs
timeFrame: Up to 34 Weeks
measure: Relationship of TEAEs
timeFrame: Up to 34 Weeks
measure: Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
timeFrame: Up to 34 Weeks
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 34 weeks
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to 34 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 34 weeks
measure: Number of participants with physical examination sign abnormalities
timeFrame: Up to 34 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 004
state: Arizona
city: Los Angeles
country: United States
facility: Local Institution - 001
state: California
city: San Diego
country: United States
facility: Local Institution - 022
state: California
city: Bristol
country: United States
facility: Local Institution - 016
state: Connecticut
city: Inverness
country: United States
facility: Local Institution - 002
state: Florida
city: Miami
country: United States
facility: Local Institution - 010
state: Florida
city: Plantation
country: United States
facility: Local Institution - 021
state: Florida
city: Gurnee
country: United States
facility: Local Institution - 020
state: Illinois
city: Iowa City
country: United States
facility: Local Institution - 008
state: Iowa
city: Albuquerque
country: United States
facility: Local Institution - 003
state: New Mexico
city: Durham
country: United States
facility: Local Institution - 018
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 012
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: