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CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Key facts

Who runs it
Celgene
Where
Albuquerque, Anderson, Atlanta, Aurora, Baltimore, Baton Rouge, Beavercreek, Birmingham, Boston, Bristol, Casper, Catonsville, Cedar Park, Chapel Hill, Charlotte, Chattanooga, Chicago, Cincinnati, Clearwater, Cleveland, Clive, Colorado Springs, Columbia, Columbus, Dallas, Denver, Draper, Durham, Farmington, Florence, Flowood, Framingham, Glen Burnie, Great Neck, Greensboro, Greenville, Gurnee, Hagerstown, Hamden, Hershey, Houston, Idaho Falls, Indianapolis, Inverness, Iowa City, Jacksonville, Kansas City, Kinston, Lancaster, Lebanon, Leesburg, Littleton, Los Angeles, Louisville, Lynchburg, Macon, Metairie, Miami, Milwaukee, Nashville, New York, North Little Rock, North Miami Beach, Oakland, Ogden, Oklahoma City, Omaha, Orlando, Philadelphia, Phoenix, Pinellas Park, Plantation, Plymouth, Port Orange, Pottsville, Providence, Richmond, Roanoke, Rochester, Rockwell, Salt Lake City, San Antonio, San Diego, Scottsdale, South Dartmouth, Southlake, Spokane, Springfield, St Louis, Sweetwater, Syracuse, Troy, Tucson, Tuscaloosa, Tyler, Vancouver, Wheat Ridge, Worcester, and Wyoming, United StatesSee the 115 sitesAlso in 14 other countries, 97 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
430 people enrolled
Started
22 Feb 2021
Ended
29 Aug 2024
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • CC-93538
  • Placebo
Record updated
13 March 2025

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 23 criteriaShow less

Who can take part

  • Participants must satisfy the following criteria to be enrolled in the study:
  • Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of > 40 kg
  • Histologic evidence of eosinophilic esophagitis, defined as a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus; 3 Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening
  • Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study
  • Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study
  • Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study
  • Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose

Who cannot take part

  • Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study
  • Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit
  • Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit
  • Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit
  • Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study
  • Prior treatment with CC-93538 during a Phase 1 or 2 clinical study
  • Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit
  • Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study
  • Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance
  • 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. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis)
  • 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
  • The presence of any of the following will exclude a participant from enrollment:
  • Evidence of a severe endoscopic structural abnormality in the esophagus
  • Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE
  • Females who are pregnant or lactating

Where in United States

Also in 14 other countries, 97 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
  • Atlanta, GeorgiaHospital not named in the registry
  • Aurora, ColoradoHospital not named in the registry
  • Baltimore, MarylandHospital 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
  • Boston, MassachusettsHospital not named in the registry
  • Bristol, ConnecticutHospital not named in the registry
  • Casper, WyomingHospital not named in the registry
  • Catonsville, MarylandHospital not named in the registry
  • Cedar Park, TexasHospital not named in the registry
  • Chapel Hill, North CarolinaHospital not named in the registry
  • Charlotte, 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
  • Cleveland, OhioHospital 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
  • Columbus, OhioHospital not named in the registry
  • Dallas, TexasHospital not named in the registry
  • Denver, ColoradoHospital not named in the registry
  • Draper, UtahHospital 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
  • Flowood, MississippiHospital not named in the registry
  • Framingham, MassachusettsHospital 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
  • Indianapolis, IndianaHospital 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
  • Kinston, North CarolinaHospital not named in the registry
  • Lancaster, CaliforniaHospital not named in the registry
  • Lebanon, New HampshireHospital not named in the registry
  • Leesburg, VirginiaHospital not named in the registry
  • Littleton, ColoradoHospital not named in the registry
  • Los Angeles, CaliforniaHospital not named in the registry
  • Louisville, KentuckyHospital 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
  • Miami, FloridaHospital not named in the registry
  • Milwaukee, WisconsinHospital not named in the registry
  • Milwaukee, WisconsinHospital not named in the registry
  • Nashville, TennesseeHospital not named in the registry
  • New YorkHospital not named in the registry
  • New YorkHospital not named in the registry
  • New YorkHospital not named in the registry
  • North Little Rock, ArkansasHospital not named in the registry
  • North Miami Beach, FloridaHospital not named in the registry
  • Oakland, CaliforniaHospital 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
  • Orlando, FloridaHospital 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
  • Providence, Rhode IslandHospital not named in the registry
  • Richmond, VirginiaHospital not named in the registry
  • Roanoke, VirginiaHospital not named in the registry
  • Rochester, MinnesotaHospital not named in the registry
  • Rockwell, TexasHospital not named in the registry
  • Salt Lake City, UtahHospital 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
  • Springfield, MassachusettsHospital not named in the registry
  • St Louis, MissouriHospital not named in the registry
  • Sweetwater, FloridaHospital not named in the registry
  • Syracuse, New YorkHospital not named in the registry
  • Syracuse, New YorkHospital not named in the registry
  • Troy, MichiganHospital not named in the registry
  • Tucson, ArizonaHospital not named in the registry
  • Tuscaloosa, AlabamaHospital 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

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase.

Read full original descriptionShow less

Participants will be randomized at the beginning of the study into 3 treatment arms:

* Placebo for Induction and Maintenance * CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance * CC-93538 360 mg SC once weekly for Induction and Maintenance

The 3 groups in the trial

  • Administration of CC-93538Treatment being tested

    CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks

    Treatment: CC-93538

  • Administration of CC-93538 and PlaceboTreatment being tested

    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.

    Treatment: CC-93538 and Placebo

  • Administration of PlaceboPlacebo, for comparison

    Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks

    Treatment: Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis
Publications
Record updated
13 March 2025