A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
NCT ID: NCT04753697
Last Updated: 2025-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
430 participants
INTERVENTIONAL
2021-02-22
2024-08-29
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Administration of CC-93538
CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks
CC-93538
Subcutaneous
Administration of CC-93538 and Placebo
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.
CC-93538
Subcutaneous
Placebo
Subcutaneous
Administration of Placebo
Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks
Placebo
Subcutaneous
Interventions
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CC-93538
Subcutaneous
Placebo
Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of \> 40 kg.
2. 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.
4\. 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.
5\. 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.
6\. 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.
7\. 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.
Exclusion Criteria
1. Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
2. 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.
3. Evidence of a severe endoscopic structural abnormality in the esophagus.
4. 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.
5. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.
6. Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.
7. Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.
8. 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.
9. Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.
10. Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.
11. Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.
12. 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).
13. Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus.
14. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.
15. Females who are pregnant or lactating.
12 Years
75 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 144
Birmingham, Alabama, United States
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Tuscaloosa, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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North Little Rock, Arkansas, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Oakland, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Wheat Ridge, Colorado, United States
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Bristol, Connecticut, United States
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Farmington, Connecticut, United States
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Hamden, Connecticut, United States
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Clearwater, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Pinellas Park, Florida, United States
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Plantation, Florida, United States
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Port Orange, Florida, United States
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Sweetwater, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Florence, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Catonsville, Maryland, United States
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Columbia, Maryland, United States
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Glen Burnie, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Framingham, Massachusetts, United States
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South Dartmouth, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Troy, Michigan, United States
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Wyoming, Michigan, United States
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Plymouth, Minnesota, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Kinston, North Carolina, United States
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pottsville, Pennsylvania, United States
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Providence, Rhode Island, United States
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Anderson, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Cedar Park, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Rockwell, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
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Tyler, Texas, United States
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Draper, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Leesburg, Virginia, United States
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Lynchburg, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Milwaukee, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Casper, Wyoming, United States
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Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Concord, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Westmead, New South Wales, Australia
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Maroorchydore, Queensland, Australia
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South Brisbane, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Elizabeth Vale, South Australia, Australia
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Clayton, Victoria, Australia
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Footscray, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Fitzroy, , Australia
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Western Australia, , Australia
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Burgenland, , Austria
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Graz, , Austria
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Linz, , Austria
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Brussels, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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West-Vlaanderen, , Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Ottawa, Ontario, Canada
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Vaughan, Ontario, Canada
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Bayern, , Germany
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Brandenburg, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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München, , Germany
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München, , Germany
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Genova, , Italy
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Milan, , Italy
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Padua, , Italy
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Pisa, , Italy
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Rome, , Italy
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Nishinomiya, Hyōgo, Japan
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Bunkyo-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
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Akita, , Japan
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Isehara City, Kanagawa, , Japan
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Kobe, , Japan
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Maebashi, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Shibukawa, , Japan
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Shinjuku-Ku, , Japan
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Tokyo, , Japan
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Toyoake, , Japan
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Yamagata, , Japan
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Bydgoszcz, , Poland
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Częstochowa, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Lódz, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Marbella, , Spain
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Seville, , Spain
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Lausanne, , Switzerland
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Belfast Northern Ireland, , United Kingdom
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Chorley, , United Kingdom
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Hexam, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
Local Institution - 226
Southampton, , United Kingdom
Countries
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References
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Dellon ES, Charriez CM, Zhang S, Falk GW, Oliva S, Ma C, Siffledeen J, Schroeder S, Philpott H, Vanuytsel T, Abe Y, Li K, Zema CL, Venkatasamy A, Yeshokumar AK, Oh YS, Schoepfer A. Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis. NEJM Evid. 2025 Oct;4(10):EVIDoa2500095. doi: 10.1056/EVIDoa2500095. Epub 2025 Sep 23.
Charriez CM, Zhang S, de Oliveira CHMC, Patel V, Oh YS, Hirano I, Schoepfer A, Dellon ES. Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis. Contemp Clin Trials. 2024 Dec;147:107708. doi: 10.1016/j.cct.2024.107708. Epub 2024 Oct 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1263-4351
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004336-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-93538-EE-001
Identifier Type: -
Identifier Source: org_study_id
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