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CompletedPhase 3

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

Key facts

Who runs it
Celgene
Where
Albuquerque, Anderson, Atlanta, Aurora, Baton Rouge, Beavercreek, Birmingham, Boston, Bristol, Cedar Park, Chapel Hill, Chattanooga, Chicago, Cincinnati, Clearwater, Clive, Colorado Springs, Columbia, Columbus, Dallas, Durham, Farmington, Florence, Glen Burnie, Great Neck, Greensboro, Greenville, Gurnee, Hagerstown, Hamden, Hershey, Houston, Idaho Falls, Inverness, Iowa City, Jacksonville, Kansas City, Lancaster, Lebanon, Los Angeles, Lynchburg, Macon, Metairie, Miami, Nashville, New York, North Little Rock, Ogden, Oklahoma City, Omaha, Orlando, Philadelphia, Phoenix, Pinellas Park, Plantation, Plymouth, Port Orange, Pottsville, Richmond, Rochester, San Antonio, San Diego, Scottsdale, South Dartmouth, Southlake, Spokane, St Louis, Syracuse, Tucson, Tyler, Vancouver, Wheat Ridge, Worcester, and Wyoming, United StatesSee the 81 sitesAlso in 14 other countries, 78 sites
Status
Completed
Phase
Phase 3
People taking part
367 people enrolled
Started
9 Aug 2022
Ended
14 Aug 2025
Type of study
Interventional
Treatments tested
  • CC-93538
Record updated
6 April 2026

Who can take part

Age
12 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Previously participated in prior clinical study CC-93538-EE-001 and either:; 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 completed the Induction Phase and does not qualify for entry to the Maintenance Phase for reasons other than a severe EoE flare; 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; 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

Who cannot take part

  • 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 an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during the CC-93538-EE-001 or CC-93538-DDI-001 studies are not eligible to participate, unless allowed following a discussion with the Clinical Trial Physician
  • 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
  • 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
  • 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
  • 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)
  • Females who are pregnant or lactating

Where in United States

Also in 14 other countries, 78 sites

  • Albuquerque, New MexicoHospital not named in the registry
  • Anderson, South CarolinaHospital not named in the registry
  • Atlanta, GeorgiaHospital not named in the registry
  • Atlanta, GeorgiaHospital not named in the registry
  • Aurora, ColoradoHospital not named in the registry
  • Baton Rouge, LouisianaHospital not named in the registry
  • Beavercreek, OhioHospital not named in the registry
  • Birmingham, AlabamaHospital not named in the registry
  • Boston, MassachusettsHospital not named in the registry
  • Bristol, ConnecticutHospital not named in the registry
  • Cedar Park, TexasHospital not named in the registry
  • Chapel Hill, North CarolinaHospital not named in the registry
  • Chattanooga, TennesseeHospital not named in the registry
  • Chicago, IllinoisHospital not named in the registry
  • Cincinnati, OhioHospital not named in the registry
  • Cincinnati, OhioHospital not named in the registry
  • Cincinnati, OhioHospital not named in the registry
  • Clearwater, FloridaHospital not named in the registry
  • Clive, IowaHospital not named in the registry
  • Colorado Springs, ColoradoHospital not named in the registry
  • Columbia, MarylandHospital not named in the registry
  • Columbus, OhioHospital not named in the registry
  • Dallas, TexasHospital not named in the registry
  • Durham, North CarolinaHospital not named in the registry
  • Farmington, ConnecticutHospital not named in the registry
  • Florence, KentuckyHospital not named in the registry
  • Glen Burnie, MarylandHospital not named in the registry
  • Great Neck, New YorkHospital not named in the registry
  • Greensboro, North CarolinaHospital not named in the registry
  • Greenville, South CarolinaHospital not named in the registry
  • Gurnee, IllinoisHospital not named in the registry
  • Hagerstown, MarylandHospital not named in the registry
  • Hamden, ConnecticutHospital not named in the registry
  • Hershey, PennsylvaniaHospital not named in the registry
  • Houston, TexasHospital not named in the registry
  • Idaho Falls, IdahoHospital not named in the registry
  • Inverness, FloridaHospital not named in the registry
  • Iowa City, IowaHospital not named in the registry
  • Jacksonville, FloridaHospital not named in the registry
  • Kansas City, KansasHospital not named in the registry
  • Kansas City, MissouriHospital not named in the registry
  • Lancaster, CaliforniaHospital not named in the registry
  • Lebanon, New HampshireHospital not named in the registry
  • Los Angeles, CaliforniaHospital not named in the registry
  • Lynchburg, VirginiaHospital not named in the registry
  • Macon, GeorgiaHospital not named in the registry
  • Metairie, LouisianaHospital not named in the registry
  • Metairie, LouisianaHospital not named in the registry
  • Miami, FloridaHospital not named in the registry
  • Nashville, TennesseeHospital not named in the registry
  • New YorkHospital not named in the registry
  • North Little Rock, ArkansasHospital not named in the registry
  • Ogden, UtahHospital not named in the registry
  • Oklahoma City, OklahomaHospital not named in the registry
  • Omaha, NebraskaHospital not named in the registry
  • Orlando, FloridaHospital not named in the registry
  • Philadelphia, PennsylvaniaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Phoenix, ArizonaHospital not named in the registry
  • Pinellas Park, FloridaHospital not named in the registry
  • Plantation, FloridaHospital not named in the registry
  • Plymouth, MinnesotaHospital not named in the registry
  • Port Orange, FloridaHospital not named in the registry
  • Pottsville, PennsylvaniaHospital not named in the registry
  • Richmond, VirginiaHospital not named in the registry
  • Rochester, MinnesotaHospital not named in the registry
  • San Antonio, TexasHospital not named in the registry
  • San Diego, CaliforniaHospital not named in the registry
  • Scottsdale, ArizonaHospital not named in the registry
  • South Dartmouth, MassachusettsHospital not named in the registry
  • Southlake, TexasHospital not named in the registry
  • Spokane, WashingtonHospital not named in the registry
  • St Louis, MissouriHospital not named in the registry
  • Syracuse, New YorkHospital not named in the registry
  • Syracuse, New YorkHospital not named in the registry
  • Tucson, ArizonaHospital not named in the registry
  • Tyler, TexasHospital not named in the registry
  • Vancouver, WashingtonHospital not named in the registry
  • Wheat Ridge, ColoradoHospital not named in the registry
  • Worcester, MassachusettsHospital not named in the registry
  • Wyoming, MichiganHospital not named in the registry

About the trial

What the trial wants to find out

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.

The group in the trial

  • Administration of CC-93538Treatment being tested

    Participants are administered CC-93538 dose subcutaneously once weekly

    Treatment: CC-93538

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Record updated
6 April 2026