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Monoclonal Antibodies

Cendakimab for Eosinophilic Esophagitis

Phase 1
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 34 weeks
Awards & highlights

Study Summary

This trial is testing a new drug for eosinophilic esophagitis and its potential interactions with other drugs.

Who is the study for?
This trial is for adults with active Eosinophilic Esophagitis (EoE) who didn't fully respond to proton-pump inhibitors. Participants should have documented symptoms and a certain number of eosinophils in the esophagus. Those using high potency steroids, immunosuppressive drugs, or on anticoagulation therapy cannot join.Check my eligibility
What is being tested?
The study is testing how Cendakimab interacts with other drugs metabolized by the body's enzymes in people with EoE. It aims to understand if having EoE changes the way Cendakimab affects these other medications.See study design
What are the potential side effects?
While specific side effects are not listed here, potential side effects may include reactions at the injection site, allergic responses, and any impacts related to changes in drug metabolism due to interactions between Cendakimab and other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have active Eosinophilic esophagitis with a high eosinophil count in my esophagus.
Select...
I tried acid reflux medication for my EoE, but it didn't fully work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 34 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Secondary outcome measures
Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants with clinical laboratory abnormalities
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of Cendakimab and Cytochrome P450 (CYP) substratesExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cendakimab
2022
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,956 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
806 Patients Enrolled for Eosinophilic Esophagitis
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,982 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
706 Patients Enrolled for Eosinophilic Esophagitis

Media Library

Cendakimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05175352 — Phase 1
Eosinophilic Esophagitis Research Study Groups: Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Eosinophilic Esophagitis Clinical Trial 2023: Cendakimab Highlights & Side Effects. Trial Name: NCT05175352 — Phase 1
Cendakimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05175352 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there various establishments in this region running the specified clinical study?

"The list of clinical trial sites, which include Tucson, Columbus and Bristol among others, stands at 13 in total. The best option to keep travel requirements low is to select the closest site if you decide to enroll in this medical study."

Answered by AI

Has Cendakimab been given authorization from the FDA?

"Due to the limited data surrounding Cendakimab's safety, efficacy and feasibility, our team at Power assigned it a score of 1."

Answered by AI

How many participants are engaged in this clinical endeavor?

"Affirmative. Confirmed by the information on clinicaltrials.gov, this research is presently enrolling participants with an initial post date of June 7th 2022 and most recent update being October 28th 2022. 15 volunteers are sought from 13 different clinics across the country."

Answered by AI

Is this medical exploration currently enrolling participants?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking participants and was most recently updated on October 28th 2022. 15 individuals are required from 13 different sites for the study which began recruiting on June 7th of last year."

Answered by AI

Does the current protocol for this research include seniors aged 55 and over?

"Patients 18 to 75 years old are eligible for this clinical trial. However, there are 26 studies available specifically designed for those below the age of consent and 36 medical trials that cater to seniors over 65."

Answered by AI

Who are the eligible participants for this medical research initiative?

"This clinical trial seeks 15 participants aged 18 to 75 with diagnosed eosinophilic esophagitis. Applicants must have an established histologic peak count of at least fifteen eosinophils per higher-power field, a history of inadequate response to proton-pump inhibitor medication and ongoing EoE symptoms logged in daily diaries during the screening period."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
How old are they?
18 - 65
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab
2022. "A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05175352.
All > Eosinophilic Esophagitis
~4 spots leftby Jan 2025
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