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Monoclonal Antibodies
Cendakimab for Eosinophilic Esophagitis
Phase 1
Waitlist Available
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
Must not have
Currently receiving a high potency topical corticosteroid for dermatologic use
On a regimen of therapeutic anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how a medication called cendakimab interacts with other drugs in people who have a condition affecting the esophagus. The goal is to see if cendakimab changes how these other medications work in the body.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am using a strong prescription cream for my skin condition.
Select...
I am currently on blood thinners for treatment.
Select...
I am on drugs that affect my immune system or have evidence of being immunosuppressed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Eosinophilic Esophagitis (EoE) include corticosteroids, dietary management, and biologic therapies such as monoclonal antibodies. Corticosteroids, like fluticasone and budesonide, work by reducing inflammation and eosinophil activity in the esophagus.
Dietary management involves eliminating specific allergens that trigger eosinophilic responses. Biologic therapies, such as Cendakimab, target specific pathways involved in the inflammatory process.
Cendakimab, for example, modulates metabolic enzymes to reduce eosinophil activation and infiltration in the esophagus. These mechanisms are crucial for EoE patients as they help to alleviate symptoms, prevent esophageal damage, and improve overall quality of life by addressing the underlying inflammatory processes.
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
645 Previous Clinical Trials
130,168 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
806 Patients Enrolled for Eosinophilic Esophagitis
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,585 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
706 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active Eosinophilic esophagitis with a high eosinophil count in my esophagus.I am using a strong prescription cream for my skin condition.I am currently on blood thinners for treatment.I am on drugs that affect my immune system or have evidence of being immunosuppressed.I tried acid reflux medication for my EoE, but it didn't fully work.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.