Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
NCT ID: NCT04991935
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
368 participants
INTERVENTIONAL
2021-09-14
2026-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
CC-93538
CC-93538
Interventions
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CC-93538
CC-93538
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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 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.
* 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.
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
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
Local Institution - 067
Colorado Springs, Colorado, United States
Local Institution - 128
Wheat Ridge, Colorado, United States
Local Institution - 101
Bristol, Connecticut, United States
Local Institution - 076
Farmington, Connecticut, United States
Local Institution - 156
Hamden, Connecticut, United States
Local Institution - 099
Clearwater, Florida, United States
Local Institution - 036
Inverness, Florida, United States
Local Institution - 042
Jacksonville, Florida, United States
Local Institution - 138
Miami, Florida, United States
Local Institution - 146
Orlando, Florida, United States
Local Institution - 169
Pinellas Park, Florida, United States
Local Institution - 168
Plantation, Florida, United States
Local Institution - 037
Port Orange, Florida, United States
Local Institution - 171
Atlanta, Georgia, United States
Local Institution - 054
Atlanta, Georgia, United States
Local Institution - 117
Macon, Georgia, United States
Local Institution - 024
Idaho Falls, Idaho, United States
Local Institution - 039
Chicago, Illinois, United States
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Gurnee, Illinois, United States
Local Institution - 127
Clive, Iowa, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
Local Institution - 046
Florence, Kentucky, United States
Local Institution - 003
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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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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South Dartmouth, Massachusetts, United States
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Worcester, Massachusetts, United States
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Wyoming, Michigan, United States
Local Institution - 115
Plymouth, Minnesota, United States
Local Institution - 049
Rochester, Minnesota, United States
Local Institution - 007
Kansas City, Missouri, United States
Local Institution - 032
St Louis, Missouri, United States
Local Institution - 038
Omaha, Nebraska, United States
Local Institution - 015
Lebanon, New Hampshire, United States
Local Institution - 139
Albuquerque, New Mexico, United States
Local Institution - 028
Great Neck, New York, United States
Local Institution - 051
New York, New York, United States
Local Institution - 116
Syracuse, New York, United States
Local Institution - 142
Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
Local Institution - 130
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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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Hershey, Pennsylvania, United States
Local Institution - 025
Philadelphia, Pennsylvania, United States
Local Institution - 155
Pottsville, Pennsylvania, United States
Local Institution - 143
Anderson, South Carolina, United States
Local Institution - 057
Greenville, South Carolina, United States
Local Institution - 114
Chattanooga, Tennessee, United States
Local Institution - 095
Nashville, Tennessee, United States
Local Institution - 105
Cedar Park, Texas, United States
Local Institution - 148
Dallas, Texas, United States
Local Institution - 112
Houston, Texas, United States
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San Antonio, Texas, United States
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Southlake, Texas, United States
Local Institution - 104
Tyler, Texas, United States
Local Institution - 125
Ogden, Utah, United States
Local Institution - 013
Lynchburg, Virginia, United States
Local Institution - 064
Richmond, Virginia, United States
Local Institution - 137
Spokane, Washington, United States
Local Institution - 023
Vancouver, Washington, United States
Local Institution - 695
Mar del Plata, , Argentina
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Quilmes, , Argentina
Local Institution - 548
Concord, New South Wales, Australia
Local Institution - 554
Liverpool, New South Wales, Australia
Local Institution - 540
Westmead, New South Wales, Australia
Local Institution - 546
Maroorchydore, Queensland, Australia
Local Institution - 550
South Brisbane, Queensland, Australia
Local Institution - 542
Woolloongabba, Queensland, Australia
Local Institution - 552
Adelaide, South Australia, Australia
Local Institution - 545
Elizabeth Vale, South Australia, Australia
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Clayton, Victoria, Australia
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Footscray, Victoria, Australia
Local Institution - 539
Melbourne, Victoria, Australia
Local Institution - 549
Murdoch, Western Australia, Australia
Local Institution - 538
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
Local Institution - 206
Victoria, British Columbia, Canada
Local Institution - 207
Ottawa, Ontario, Canada
Local Institution - 200
Vaughan, Ontario, Canada
Local Institution - 330
Bayern, , Germany
Local Institution - 332
Brandenburg, , Germany
Local Institution - 339
Frankfurt am Main, , Germany
Local Institution - 338
Leipzig, , Germany
Local Institution - 337
München, , Germany
Local Institution - 278
Tel Aviv, Tel Aviv, Israel
Local Institution - 281
Haifa, , Israel
Local Institution - 283
Holon, , Israel
Local Institution - 280
Jerusalem, , Israel
Local Institution - 282
Jerusalem, , Israel
Local Institution - 279
Ẕerifin, , Israel
Local Institution - 257
Genova, , Italy
Local Institution - 254
Milan, , Italy
Local Institution - 255
Padua, , Italy
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Pisa, , Italy
Local Institution - 253
Rome, , Italy
Local Institution - 600
Nishinomiya, Hyōgo, Japan
Local Institution - 595
Bunkyo-ku, Tokyo, Japan
Local Institution - 599
Setagaya-ku, Tokyo, Japan
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Akita, , Japan
Local Institution - 606
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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Okayama, , Japan
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Shinjuku-Ku, , Japan
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Tokyo, , 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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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
Local Institution - 308
Porto, , Portugal
Local Institution - 408
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
Local Institution - 412
Seville, , Spain
Local Institution - 357
Lausanne, , Switzerland
Local Institution - 228
Belfast Northern Ireland, , United Kingdom
Local Institution - 231
Birmingham, , United Kingdom
Local Institution - 234
Cardiff, , United Kingdom
Local Institution - 235
Chorley, , United Kingdom
Local Institution - 233
Hexam, , United Kingdom
Local Institution - 236
Liverpool, , United Kingdom
Local Institution - 237
Manchester, , United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-004335-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-93538-EE-002
Identifier Type: -
Identifier Source: org_study_id
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