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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.
Must not have
Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 48
Awards & highlights
Pivotal Trial
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have active infections like hepatitis, TB, or HIV.
Select...
I have had COVID-19 within the last 4 weeks.
Select...
I am not pregnant or breastfeeding.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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%
Upper respiratory tract infection
7%
COVID-19
7%
Conjunctivitis allergic
6%
Folliculitis
6%
Fatigue
6%
Alanine aminotransferase increased
6%
Blood creatine phosphokinase increased
4%
Nasopharyngitis
4%
Back pain
4%
Headache
2%
Deep vein thrombosis
2%
Pulmonary hypertension
2%
Injection site erythema
2%
Respiratory tract infection
2%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Treatment 1
Treatment 2
Treatment 3
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
645 Previous Clinical Trials
129,785 Total Patients Enrolled
4 Trials studying Eosinophilic Esophagitis
423 Patients Enrolled for Eosinophilic Esophagitis
Cristian Rodriguez, MDStudy DirectorBristol-Myers Squibb
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,202 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
323 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.