Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
- Registration Number
- NCT04991935
- Lead Sponsor
- Celgene
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 259
-
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.
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of CC-93538 CC-93538 Participants are administered CC-93538 dose subcutaneously once weekly
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) For a minimum of 28 months An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
- Secondary Outcome Measures
Name Time Method Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies For a minimum of 28 months This includes neutralizing antibodies when warranted.
Trial Locations
- Locations (167)
Local Institution - 082
🇺🇸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 - 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
Local Institution - 167
🇺🇸Gurnee, Illinois, United States
Local Institution - 127
🇺🇸Clive, Iowa, United States
Local Institution - 094
🇺🇸Iowa City, Iowa, United States
Local Institution - 035
🇺🇸Kansas City, Kansas, United States
Local Institution - 020
🇺🇸Metairie, Louisiana, United States
Local Institution - 044
🇺🇸Metairie, Louisiana, United States
Local Institution - 070
🇺🇸Glen Burnie, Maryland, United States
Local Institution - 053
🇺🇸Boston, Massachusetts, United States
Local Institution - 083
🇺🇸South Dartmouth, Massachusetts, United States
Local Institution - 014
🇺🇸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
🇺🇸Saint 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 - 051
🇺🇸New York, New York, United States
Local Institution - 116
🇺🇸Syracuse, New York, United States
Local Institution - 142
🇺🇸Syracuse, New York, United States
Local Institution - 016
🇺🇸Chapel Hill, North Carolina, United States
Local Institution - 106
🇺🇸Durham, North Carolina, United States
Local Institution - 130
🇺🇸Beavercreek, Ohio, United States
Local Institution - 006
🇺🇸Cincinnati, Ohio, United States
Local Institution - 001
🇺🇸Cincinnati, Ohio, United States
Local Institution - 052
🇺🇸Cincinnati, Ohio, United States
Local Institution - 059
🇺🇸Columbus, Ohio, United States
Local Institution - 120
🇺🇸Hershey, Pennsylvania, United States
Local Institution - 025
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution - 155
🇺🇸Pottsville, Pennsylvania, United States
Local Institution - 057
🇺🇸Greenville, South Carolina, United States
Local Institution - 095
🇺🇸Nashville, Tennessee, United States
Local Institution - 105
🇺🇸Cedar Park, Texas, United States
Local Institution - 112
🇺🇸Houston, Texas, United States
Local Institution - 008
🇺🇸San Antonio, Texas, United States
Local Institution - 077
🇺🇸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 - 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 - 539
🇦🇺Melbourne, Victoria, Australia
Local Institution - 549
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 547
🇦🇺Western Australia, Australia
Local Institution - 436
🇦🇹Linz, Austria
Local Institution - 514
🇧🇪Leuven, Belgium
Local Institution - 512
🇧🇪West-Vlaanderen, Belgium
Local Institution - 201
🇨🇦Calgary, Alberta, Canada
Local Institution - 208
🇨🇦Edmonton, Alberta, Canada
Local Institution - 205
🇨🇦Edmonton, Alberta, Canada
Local Institution - 203
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 206
🇨🇦Victoria, British Columbia, Canada
Local Institution - 200
🇨🇦Vaughan, Ontario, Canada
Local Institution - 330
🇩🇪Bayern, Germany
Local Institution - 332
🇩🇪Brandenburg an der Havel, Germany
Local Institution - 337
🇩🇪Munchen, Germany
Local Institution - 254
🇮🇹Milano, Italy
Local Institution - 255
🇮🇹Padova, Italy
Local Institution - 253
🇮🇹Rome, Italy
Local Institution - 390
🇵🇱Gdansk, Poland
Local Institution - 383
🇵🇱Warsaw, Poland
Local Institution - 391
🇵🇱Wroclaw, Poland
Local Institution - 305
🇵🇹Lisboa, Portugal
Local Institution - 306
🇵🇹Porto, Portugal
Local Institution - 308
🇵🇹Porto, Portugal
Local Institution - 357
🇨🇭Lausanne, Switzerland
Local Institution - 228
🇬🇧Belfast Northern Ireland, United Kingdom
Local Institution - 237
🇬🇧Manchester, United Kingdom
Local Institution - 144
🇺🇸Birmingham, Alabama, United States
Local Institution - 147
🇺🇸Phoenix, Arizona, United States
Local Institution - 146
🇺🇸Orlando, Florida, United States
Local Institution - 169
🇺🇸Pinellas Park, Florida, United States
Local Institution - 046
🇺🇸Florence, Kentucky, United States
Local Institution - 003
🇺🇸Baton Rouge, Louisiana, United States
Local Institution - 164
🇺🇸Columbia, Maryland, United States
Local Institution - 012
🇺🇸Hagerstown, Maryland, United States
Local Institution - 009
🇺🇸Worcester, Massachusetts, United States
Local Institution - 028
🇺🇸Great Neck, New York, United States
Local Institution - 131
🇺🇸Greensboro, North Carolina, United States
Local Institution - 166
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 143
🇺🇸Anderson, South Carolina, United States
Local Institution - 114
🇺🇸Chattanooga, Tennessee, United States
Local Institution - 148
🇺🇸Dallas, Texas, United States
Local Institution - 695
🇦🇷Mar Del Plata, Argentina
Local Institution - 696
🇦🇷Quilmes, Argentina
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
Local Institution - 553
🇦🇺Clayton, Victoria, Australia
Local Institution - 543
🇦🇺Footscray, Victoria, Australia
Local Institution - 538
🇦🇺Fitzroy, Australia
Local Institution - 437
🇦🇹Burgenland, Austria
Local Institution - 516
🇧🇪Kortrijk, Belgium
Local Institution - 434
🇦🇹Graz, Austria
Local Institution - 515
🇧🇪Brussels, Belgium
Local Institution - 207
🇨🇦Ottawa, Ontario, Canada
Local Institution - 339
🇩🇪Frankfurt am Main, Germany
Local Institution - 338
🇩🇪Leipzig, 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
🇮🇱Zerifin, Israel
Local Institution - 257
🇮🇹Genova, Italy
Local Institution - 252
🇮🇹Pisa, Italy
Local Institution - 600
🇯🇵Nishinomiya, Hyogo, Japan
Local Institution - 595
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 599
🇯🇵Setagaya-ku, Tokyo, Japan
Local Institution - 593
🇯🇵Akita-shi, Japan
Local Institution - 606
🇯🇵Isehara City, Kanagawa, Japan
Local Institution - 597
🇯🇵Kobe, Japan
Local Institution - 598
🇯🇵Maebashi, Japan
Local Institution - 607
🇯🇵Nagoya, Japan
Local Institution - 603
🇯🇵Okayama-Shi, Japan
Local Institution - 602
🇯🇵Shinjuku-Ku, Japan
Local Institution - 605
🇯🇵Tokyo, Japan
Local Institution - 590
🇯🇵Yamagata, Japan
Local Institution - 385
🇵🇱Bydgoszcz, Poland
Local Institution - 389
🇵🇱Częstochowa, Poland
Local Institution - 388
🇵🇱Katowice, Poland
Local Institution - 392
🇵🇱Lódz, Poland
Local Institution - 387
🇵🇱Warszawa, Poland
Local Institution - 393
🇵🇱Warszawa, Poland
Local Institution - 384
🇵🇱Wroclaw, Poland
Local Institution - 307
🇵🇹Lisboa, Portugal
Local Institution - 408
🇪🇸Barcelona, Spain
Local Institution - 410
🇪🇸Cordoba, Spain
Local Institution - 409
🇪🇸Madrid, Spain
Local Institution - 413
🇪🇸Madrid, Spain
Local Institution - 411
🇪🇸Marbella, Spain
Local Institution - 412
🇪🇸Sevilla, Spain
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