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

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05175352
Collaborator
(none)
15
Enrollment
19
Locations
1
Arm
20.9
Anticipated Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 7, 2022
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Mar 5, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of Cendakimab and Cytochrome P450 (CYP) substrates

Drug: Cendakimab
Specified dose on specified days

Drug: CYP substrates
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞) [Up to 18 Weeks]

  2. Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h) [Up to 18 Weeks]

Secondary Outcome Measures

  1. Pharmacokinetics - Maximum plasma concentration of drug (Cmax) [Up to 18 Weeks]

  2. Incidence of Treatment-Emergent Adverse Events (TEAEs) [Up to 34 Weeks]

  3. Severity of TEAEs [Up to 34 Weeks]

  4. Relationship of TEAEs [Up to 34 Weeks]

  5. Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time [Up to 34 Weeks]

  6. Number of participants with clinical laboratory abnormalities [Up to 34 weeks]

  7. Number of participants with electrocardiogram abnormalities [Up to 34 weeks]

  8. Number of participants with vital sign abnormalities [Up to 34 weeks]

  9. Number of participants with physical examination sign abnormalities [Up to 34 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwest Allied Physicians LLC & Del Sol Research (SMO) Tucson Arizona United States 85712
2 Gastrointestinal Biosciences Los Angeles California United States 90067
3 Peak Gastroenterology Associates Colorado Springs Colorado United States 80920
4 Connecticut Gastroenterology Institute Bristol Connecticut United States 06010-5142
5 Nature Coast Clinical Research LLC Inverness Florida United States 34452
6 Nature Coast Clinical Research LLC Inverness Florida United States 34452
7 Homestead Associates in Research Inc Miami Florida United States 33032
8 A Plus Research Inc Miami Florida United States 33144-2035
9 University Of Iowa Hospitals And Clinics Iowa City Iowa United States 52242
10 University of Kansas Medical Center Westwood Kansas United States 66205
11 University of Louisville Louisville Kentucky United States 40202
12 New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico United States 87106-4725
13 New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico United States 87106-4725
14 SUNY Upstate Medical University Syracuse New York United States 13210
15 Duke University Medical Center Durham North Carolina United States 27710
16 Optimed Research Ltd Columbus Ohio United States 43235
17 Houston Endoscopy and Research Center Houston Texas United States 77079
18 University of Utah Health Care Salt Lake City Utah United States 84132
19 McGuire Veterans Affairs Medical Center Richmond Virginia United States 23249

Sponsors and Collaborators

  • Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT05175352
Other Study ID Numbers:
  • CC-93538-DDI-001
First Posted:
Jan 3, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celgene
Eosinophilic Esophagitis
Cendakimab
Drug-drug interactions
DDI
Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis

Study Results

No Results Posted as of Jun 21, 2022