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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR
Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance Phase and completed Week 48 of the Maintenance Phase; OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for a minimum of 28 months
Awards & highlights
Study Summary
This trial is testing the safety and tolerability of a drug called CC-93538. The trial is open-label, which means that everyone knows what treatment they are getting, and uncontrolled, which means that there is no comparison group. The trial will enroll people who have already participated in other studies of CC-93538.
Who is the study for?
This trial is for adults and adolescents who have Eosinophilic Esophagitis (EoE) and were part of previous CC-93538 studies. They must not have other conditions that could affect the study, no severe allergies to ingredients in CC-93538, no recent immunotherapy or live vaccines, and women must test negative for pregnancy and use contraception.Check my eligibility
What is being tested?
The trial tests the long-term safety of a drug called CC-93538 in patients with EoE who participated in earlier related trials. It's an open-label study, meaning everyone knows they're getting the drug, without a comparison group.See study design
What are the potential side effects?
While specific side effects are not listed here, participants from prior studies are excluded if they had clinically significant adverse events to CC-93538 that would prevent further dosing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a severe EoE flare-up needing urgent treatment and finished 24 weeks of the initial treatment phase.
Select...
I had a severe EoE flare needing endoscopy or extra treatment and finished Week 48 of the maintenance phase.
Select...
I have completed 48 weeks of the maintenance phase.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for a minimum of 28 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a minimum of 28 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs)
Secondary outcome measures
Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies
Side effects data
From 2022 Phase 2 trial • 221 Patients • NCT0480031537%
Dermatitis atopic
7%
COVID-19
7%
Upper respiratory tract infection
7%
Conjunctivitis allergic
6%
Fatigue
6%
Blood creatine phosphokinase increased
6%
Folliculitis
6%
Alanine aminotransferase increased
4%
Headache
4%
Back pain
4%
Nasopharyngitis
2%
Respiratory tract infection
2%
Injection site erythema
2%
Cellulitis
2%
Deep vein thrombosis
2%
Pulmonary hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 1
Treatment 2
Treatment 3
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of CC-93538Experimental Treatment1 Intervention
Participants are administered CC-93538 dose subcutaneously once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-93538
2021
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,595 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
562 Patients Enrolled for Eosinophilic Esophagitis
Christian Rodriguez, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,564 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
462 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken any immune-weakening drugs recently.I haven't taken any experimental drugs recently, except for those in specific studies.I do not have any health conditions that could interfere with the study or increase my risk by participating.I am not pregnant and agree to use effective birth control during and for 5 months after treatment.I am not pregnant or breastfeeding.I had a severe EoE flare-up needing urgent treatment and finished 24 weeks of the initial treatment phase.I have an active Helicobacter pylori infection or esophageal varices.I haven't taken oral or sublingual immunotherapy in the last 6 months.I do not have any active or suspected parasitic infections or chronic infections like hepatitis, tuberculosis, or HIV.I have not received a live vaccine in the last month and do not plan to during the study.I had a severe EoE flare needing endoscopy or extra treatment and finished Week 48 of the maintenance phase.I have completed 48 weeks of the maintenance phase.I don't have other conditions that could affect this study's results.You have had a severe allergic reaction or major immune system reaction to a medication that contains immunoglobulin-G. Or, you have a known allergy to any ingredient in CC-93538.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of CC-93538
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project enroll seniors as participants?
"The age limit for this trial is 75 years old, and participants must be over the age of 12."
Answered by AI
How does CC-93538 put people at risk?
"There is already some efficacy data and multiple rounds of safety data available from Phase 3 clinical trials, so CC-93538 received a score of 3 for safety."
Answered by AI
Can anyone sign up for this experiment yet, or are the slots all full?
"That is accurate, the information on clinicaltrials.gov reveals that this trial has an open call for participants. The listing went up on September 14th, 2021 and was most recently updated on November 11th, 2022. There are 259 patients needed to be enrolled at 100 sites total."
Answered by AI
What are the prerequisites for being a test subject in this experiment?
"This medical trial is looking for 259 individuals with eosinophilic esophagitis between the ages of 12 and 75. To be eligible, applicants must meet one of the following criteria: They experienced a severe EoE flare-up requiring endoscopic intervention and/or rescue therapy during the Induction Phase and have completed Week 24 of the Induction Phase; OR They completed the Induction Phase but do not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR They experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Maintenance"
Answered by AI
Who else is applying?
What state do they live in?
Kansas
Florida
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Tufts - New England Medical Center
Digestive Disease Specialists Inc.
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I want a cure for Eoe.
PatientReceived 2+ prior treatments
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