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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

A Phase 3, Multicenter, Multinational, Open-Label Extension Study to Evaluate the Long-Term Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis

NCT04991935•Celgene

View on ClinicalTrials.gov

Summary

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Previously participated in prior clinical study CC-93538-EE-001 and either:
•1. 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
•2. Subject completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; OR
•3. 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
•4. Subject completed Week 48 of the Maintenance Phase
•OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit
•Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.
•Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.
•Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.

Exclusion Criteria

•Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
•Active Helicobacter pylori infection or esophageal varices.
•Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
•Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
•Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
•Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
•Active parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (viral hepatitis, tuberculosis, or HIV)
•Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
•Females who are pregnant or lactating.

Locations (167)

Local Institution - 144

Birmingham, Alabama, United States

Local Institution - 082

Phoenix, Arizona, United States

Local Institution - 147

Phoenix, Arizona, United States

Local Institution - 041

Scottsdale, Arizona, United States

Local Institution - 029

Tucson, Arizona, United States

Local Institution - 165

North Little Rock, Arkansas, United States

Local Institution - 075

Lancaster, California, United States

Local Institution - 047

Los Angeles, California, United States

Local Institution - 160

San Diego, California, United States

Local Institution - 068

Aurora, Colorado, United States

Key Dates

Start Date

September 14, 2021

Primary Completion Date

August 14, 2025

Completion Date

September 29, 2026

Last Updated

September 18, 2025

Enrollment

368

ACTUAL participants

Conditions

Eosinophilic Esophagitis

Interventions

CC-93538

DRUG

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Prospective Registry of EoSinophilic esOphagitis

Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE