Eosinophilic EsophagitisPhase 1NCT05175352
A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab
A Phase 1 study testing Cendakimab and CYP substrates in people with Eosinophilic Esophagitis, run by Celgene at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Cendakimab and CYP substrates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Jun 2022to 11 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Local Institution - 003
Albuquerque, New Mexico, 87106-4725
Local Institution - 016
Bristol, Connecticut, 06010-5142
Local Institution - 012
Columbus, Ohio, 43235
Local Institution - 018
Durham, North Carolina, 27710
Local Institution - 020
Gurnee, Illinois, 60031-5711
Local Institution - 002
Inverness, Florida, 34452
Local Institution - 008
Iowa City, Iowa, 52242
Local Institution - 001
Los Angeles, California, 90067
Local Institution - 010
Miami, Florida, 33144-2035
Local Institution - 021
Plantation, Florida, 33324-3345
Local Institution - 022
San Diego, California, 92103-5639
Local Institution - 004
Tucson, Arizona, 85715
About this study
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
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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Cendakimab, CYP substrates
- Keywords
- Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CendakimabDrug
Also called CC-93538, BMS-986355
Specified dose on specified days
CYP substratesDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of Cendakimab and Cytochrome P450 (CYP) substrates | Experimental | Not described Receives: Drug: Cendakimab; Drug: CYP substrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Measured: Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Measured: Up to 18 Weeks
Secondary outcomes (9)
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Measured: Up to 18 Weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to 34 Weeks
Severity of TEAEs
Measured: Up to 34 Weeks
Relationship of TEAEs
Measured: Up to 34 Weeks
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Measured: Up to 34 Weeks
Number of participants with clinical laboratory abnormalities
Measured: Up to 34 weeks
Number of participants with electrocardiogram abnormalities
Measured: Up to 34 weeks
Number of participants with vital sign abnormalities
Measured: Up to 34 weeks
Number of participants with physical examination sign abnormalities
Measured: Up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start7 Jun 2022
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175352
- Sponsor's protocol ID
- CC-93538-DDI-001
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2021
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05175352
- Acronym / sponsor ID
- CC-93538-DDI-001
- Conditions
- Eosinophilic Esophagitis
- Keywords
- Eosinophilic Esophagitis, Cendakimab, Drug-drug interactions, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Cendakimab and Cytochrome P450 (CYP) substrates | Experimental | Drug: Cendakimab, Drug: CYP substrates |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CendakimabAlso: CC-93538, BMS-986355Specified dose on specified days | Drug | Administration of Cendakimab and Cytochrome P450 (CYP) substrates |
| CYP substratesSpecified dose on specified days | Drug | Administration of Cendakimab and Cytochrome P450 (CYP) substrates |
Primary outcome
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Time frame: Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Time frame: Up to 18 Weeks
9 secondary outcomes
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time frame: Up to 18 Weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 34 Weeks
Severity of TEAEs
Time frame: Up to 34 Weeks
Relationship of TEAEs
Time frame: Up to 34 Weeks
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Time frame: Up to 34 Weeks
Number of participants with clinical laboratory abnormalities
Time frame: Up to 34 weeks
Number of participants with electrocardiogram abnormalities
Time frame: Up to 34 weeks
Number of participants with vital sign abnormalities
Time frame: Up to 34 weeks
Number of participants with physical examination sign abnormalities
Time frame: Up to 34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cendakimab and CYP substrates in people with Eosinophilic Esophagitis, run by Celgene at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞) (time frame: Up to 18 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.