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Monoclonal Antibodies
CC-93538 for Eosinophilic Esophagitis
Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg.
Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 48
Awards & highlights
Study Summary
This trial is testing a new medication for people with Eosinophilic Esophagitis. The trial has two phases, induction and maintenance, each lasting 24 weeks. There are three treatment groups, one receiving a placebo and two receiving the trial medication.
Who is the study for?
Adults and adolescents aged 12-75 with a body weight over 40 kg, diagnosed with eosinophilic esophagitis (EoE), showing specific levels of eosinophils in the esophagus. They must have had symptoms like difficulty swallowing and not fully responded to acid reflux medication. Stable doses of certain other medications are required, and females capable of childbearing need negative pregnancy tests and must use contraception.Check my eligibility
What is being tested?
The trial is testing CC-93538's effectiveness for EoE treatment against a placebo. Participants will be randomly assigned to receive either CC-93538 or a placebo during a 24-week Induction Phase followed by a Maintenance Phase. The drug is administered subcutaneously once weekly or every other week depending on the phase.See study design
What are the potential side effects?
While specific side effects for CC-93538 aren't listed, common ones may include injection site reactions, potential allergic responses, gastrointestinal disturbances, headaches, fatigue, or flu-like symptoms as seen with similar treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 75 years old and weigh more than 40 kg.
Select...
I've had trouble swallowing on 4 or more days in the last 2 weeks.
Select...
I've had trouble swallowing on 4 or more days in the last 2 weeks.
Select...
I am between 12 and 75 years old and weigh more than 40 kg.
Select...
My biopsy shows I have eosinophilic esophagitis with a high eosinophil count.
Select...
My biopsy shows I have eosinophilic esophagitis with a high eosinophil count.
Select...
I've had trouble swallowing on 4 or more days in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Assessment of Immunogenicity through measurement of serum concentrations of anti-drug antibodies to CC-93538
Change in DD Clinical Response
DD Clinical Responder Definition
+20 moreSide 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%
Back pain
4%
Nasopharyngitis
4%
Headache
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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of CC-93538 and PlaceboExperimental Treatment2 Interventions
CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks.
During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.
Group II: Administration of CC-93538Experimental Treatment1 Intervention
CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks
Group III: Administration of PlaceboPlacebo Group1 Intervention
Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks
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
128,572 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
422 Patients Enrolled for Eosinophilic Esophagitis
Cristian Rodriguez, MDStudy DirectorBristol-Myers Squibb
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,131 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
322 Patients Enrolled for Eosinophilic Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 2 negative pregnancy tests and will use effective birth control until 5 months after my last treatment dose.I have been on a stable dose of certain asthma or skin medications for at least 4 weeks.I have taken medication for EoE by swallowing it in the last 4 weeks.I have been on a stable dose of proton pump inhibitor for 4 weeks without complete relief.I have other health conditions that could affect this study's tests.I tried a heartburn medication for 8 weeks without full relief.I am between 12 and 75 years old and weigh more than 40 kg.I haven't used strong skin creams or oral steroids in the last 8 weeks.I've had trouble swallowing on 4 or more days in the last 2 weeks.You have a medical condition that would make it difficult to carry out the study or understand the results, or it could be risky for you to participate (like severe asthma, certain infections, heart problems, neurological disorders, or psychiatric illnesses that affect your ability to report symptoms accurately).I do not have active infections like hepatitis, TB, or HIV.I have had COVID-19 within the last 4 weeks.I have been on a stable dose of proton pump inhibitor for 4 weeks without complete relief.I've had trouble swallowing on 4 or more days in the last 2 weeks.I am between 12 and 75 years old and weigh more than 40 kg.I have been on stable doses of certain medications for at least 4 weeks.I haven't taken oral or sublingual immunotherapy in the last 6 months.I have not received a live vaccine in the last 4 weeks.My biopsy shows I have eosinophilic esophagitis with a high eosinophil count.I do not have active stomach issues like H. pylori, varices, or liver problems.I've been on stable doses of certain asthma or skin medications for at least 4 weeks.I have had or may need a procedure to widen my esophagus soon.My biopsy shows I have eosinophilic esophagitis with a high eosinophil count.I have not taken any immune-weakening drugs recently.I successfully followed a special diet that completely improved my EoE symptoms.You have received treatment with CC-93538 in a previous research study.I am not pregnant or breastfeeding.I've had trouble swallowing on 4 or more days in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of CC-93538
- Group 2: Administration of CC-93538 and Placebo
- Group 3: Administration of Placebo
Awards:
This trial has 1 awards, including:- 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 the age limit for this clinical trial exclude people over 25 years old?
"Eligible applicants for this particular clinical trial must be aged 12 to 75. There are 26 trials involving patients that are younger and 37 trials focusing on older adults."
Answered by AI
Is this research being carried out in numerous hospitals across America?
"There are many enrolment locations for this trial, including University Of Louisville in Louisville, Kentucky, Boston Specialists in Boston, Massachusetts, and GastroIntestinal Biosciences in Los Angeles, California."
Answered by AI
May I join this experimental research project?
"This medical study is looking for 399 patients, both male and female, aged 12 to 75, who currently have eosinophilic esophagitis. In addition to this broad age range and current diagnosis, participants must also meet the following specific criteria: a body weight of over 40 kg., histologic evidence of eosinophilic esophagitis as defined by a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus; 3 or more Dysphagia Days reported within 2 consecutive weeks prior to end of screening; lack of complete response to an"
Answered by AI
Does CC-93538 have any potential to harm patients?
"There is some evidence of CC-93538's efficacy and it has undergone multiple rounds of testing, so it received a score of 3 for safety."
Answered by AI
How many participants are being accepted into this experiment?
"399 patients are required to fill the spots for this clinical trial. Celgene, the sponsor of this study, will be running it from several locations; two examples include University Of Louisville and Boston Specialists."
Answered by AI
Are participants still being recruited for this research?
"Yes, the website clinicaltrials.gov has the latest information on this study which is still recruiting patients. The original posting was on February 22nd, 2021 and there have been updates as recently as November 15th, 2022. So far, 399 people have signed up at 100 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Utah
Indiana
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
Med-Care Research
Indiana University
University of Kansas Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
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