Eosinophilic Esophagitis Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 259 |
| Est. completion date | September 29, 2026 |
| Est. primary completion date | June 9, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Previously participated in prior clinical study CC-93538-EE-001 and either: 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: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 697 | Buenos Aires | |
| Argentina | Local Institution - 694 | BuenosAires | |
| Argentina | Local Institution - 695 | Mar Del Plata | |
| Argentina | Local Institution - 696 | Quilmes | |
| Argentina | Local Institution - 698 | San Miguel de Tucumán | |
| Australia | Local Institution - 552 | Adelaide | South Australia |
| Australia | Local Institution - 553 | Clayton | Victoria |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | Local Institution - 545 | Elizabeth Vale | South Australia |
| Australia | Local Institution - 538 | Fitzroy | |
| Australia | Local Institution - 543 | Footscray | Victoria |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Coastal Digestive Health | Maroorchydore | Queensland |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Local Institution - 551 | North Mackay | Queensland |
| Australia | Local Institution - 550 | South Brisbane | Queensland |
| Australia | St John of God Midland Hospital | Western Australia | |
| Australia | The Childrens Hospital at Westmead | Westmead | New South Wales |
| Australia | Local Institution - 542 | Woolloongabba | Queensland |
| Austria | Local Institution - 437 | Burgenland | |
| Austria | Local Institution - 434 | Graz | |
| Austria | Hospital of Barmherzige Schwestern Linz | Linz | |
| Austria | Local Institution - 435 | Vienna | |
| Belgium | Local Institution - 515 | Brussels | |
| Belgium | Local Institution - 516 | Kortrijk | |
| Belgium | Uz Leuven | Leuven | |
| Belgium | AZ Sint-Lucas Brugge | West-Vlaanderen | |
| Canada | University Of Calgary | Calgary | Alberta |
| Canada | GIRI Gastroenterology and Internal Medicine Research Institute | Edmonton | Alberta |
| Canada | Local Institution - 202 | Edmonton | Alberta |
| Canada | South Edmonton Gastroenterology | Edmonton | Alberta |
| Canada | Local Institution - 207 | Ottawa | Ontario |
| Canada | Local Institution - 204 | Toronto | Ontario |
| Canada | GI Research Institute | Vancouver | British Columbia |
| Canada | Toronto Digestive Disease Associates Inc | Vaughan | Ontario |
| Canada | Percuro Clinical Research Ltd | Victoria | British Columbia |
| Germany | Klinikum Garmisch-Partenkirchen Gmbh | Bayern | |
| Germany | Staedisches Klinikum Brandenburg | Brandenburg an der Havel | |
| Germany | Local Institution - 339 | Frankfurt am Main | |
| Germany | Local Institution - 336 | Hamburg | |
| Germany | Local Institution - 333 | Leipzig | |
| Germany | Local Institution - 338 | Leipzig | |
| Germany | Local Institution - 334 | Mainz | |
| Germany | Klinikum Rechts der Isar der Technischen Universitaet Muenchen | Munchen | |
| Germany | Local Institution - 340 | München | |
| Israel | Local Institution - 281 | Haifa | |
| Israel | Local Institution - 283 | Holon | |
| Israel | Local Institution - 280 | Jerusalem | |
| Israel | Local Institution - 282 | Jerusalem | |
| Israel | Local Institution - 278 | Tel-Aviv | Tel Aviv |
| Israel | Local Institution - 279 | Zerifin | |
| Italy | Local Institution - 257 | Genova | |
| Italy | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Local Institution - 256 | Napoli | |
| Italy | Azienda Ospedaliera Di Padova | Padova | |
| Italy | Local Institution - 252 | Pisa | |
| Italy | Azienda Policlinico Umberto I | Rome | |
| Japan | Akita University Hospital | Akita-shi | |
| Japan | Nippon Medical School Hospital | Bunkyo-ku | Tokyo |
| Japan | Local Institution - 606 | Isehara City, Kanagawa | |
| Japan | Kobe University Hospital | Kobe | |
| Japan | Local Institution - 598 | Maebashi | |
| Japan | Local Institution - 604 | Nagoya | |
| Japan | Local Institution - 607 | Nagoya | |
| Japan | Local Institution - 592 | Niigata-shi | |
| Japan | Local Institution - 600 | Nishinomiya | Hyogo |
| Japan | Local Institution - 603 | Okayama-Shi | |
| Japan | Local Institution - 591 | Osaka | |
| Japan | Local Institution - 599 | Setagaya-ku | Tokyo |
| Japan | Local Institution - 601 | Shibukawa | |
| Japan | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-Ku | |
| Japan | International University of Health and Werfare Mita Hospital | Tokyo | |
| Japan | Local Institution - 596 | Toyoake | |
| Japan | Yamagata University Hospital | Yamagata | |
| Poland | Local Institution - 385 | Bydgoszcz | |
| Poland | Local Institution - 389 | Czestochowa | |
| Poland | AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | |
| Poland | Local Institution - 388 | Katowice | |
| Poland | Local Institution - 392 | Lódz | |
| Poland | Local Institution - 382 | Szczecin | |
| Poland | WIP Warsaw IBD Point | Warsaw | |
| Poland | Local Institution - 387 | Warszawa | |
| Poland | Local Institution - 393 | Warszawa | |
| Poland | AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | |
| Poland | Local Institution - 384 | Wroclaw | |
| Poland | Local Institution - 386 | Wroclaw | |
| Portugal | Centro Hospitalar Lisboa Norte EPE Hospital de Santa Maria | Lisboa | |
| Portugal | Local Institution - 307 | Lisboa | |
| Portugal | Centro Hospitalar de São João, E.P.E. | Porto | |
| Portugal | Centro Hospitalar do Porto Hospital de Santo Antonio | Porto | |
| Spain | 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 | |
| Switzerland | Chuv Bh-04 | Lausanne | |
| Switzerland | Local Institution - 356 | Liestal | |
| United Kingdom | Belfast Health and Social Care Trust | Belfast Northern Ireland | |
| United Kingdom | Local Institution - 231 | Birmingham | |
| United Kingdom | Local Institution - 229 | Cambridge | |
| United Kingdom | Local Institution - 234 | Cardiff | |
| United Kingdom | Local Institution - 235 | Chorley | |
| United Kingdom | Local Institution - 232 | Hardwick | |
| United Kingdom | Local Institution - 233 | Hexam | |
| United Kingdom | Local Institution - 236 | Liverpool | |
| United Kingdom | Local Institution - 230 | Manchester | |
| United Kingdom | Local Institution - 237 | Manchester | |
| United Kingdom | Local Institution - 226 | Southampton | |
| United States | New Mexico Clinical Research and Osteoporosis Center | Albuquerque | New Mexico |
| United States | Local Institution - 143 | Anderson | South Carolina |
| United States | AES - DRS - Synexus Clinical Research US, Inc. - Atlanta | Atlanta | Georgia |
| United States | Children's Center for Digestive Healthcare | Atlanta | Georgia |
| United States | Emory University School of Medicine | Atlanta | Georgia |
| United States | Childrens Hospital Colorado | Aurora | Colorado |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Gastroenterology Associates LLC | Baton Rouge | Louisiana |
| United States | Dayton Gastroenterology, Inc | Beavercreek | Ohio |
| United States | Local Institution - 144 | Birmingham | Alabama |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Boston Specialists | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Connecticut Clinical Research Foundation | Bristol | Connecticut |
| United States | University of Vermont Medical Center Gastro | Burlington | Vermont |
| United States | Gastroenterology Associates, PC - Casper - CAR | Casper | Wyoming |
| United States | Digestive Disease Associates, PA | Catonsville | Maryland |
| United States | Texas Digestive Disease Consultants Dallas | Cedar Park | Texas |
| United States | University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
| United States | Clinical Research of Charlotte | Charlotte | North Carolina |
| United States | Local Institution - 114 | Chattanooga | Tennessee |
| United States | Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois |
| United States | Northwestern University Feinberg School Of Medicine | Chicago | Illinois |
| United States | University Of Chicago | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | GCGA Physicians, LLC dba/Gastro Health Research | Cincinnati | Ohio |
| United States | University Of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Gastro Florida | Clearwater | Florida |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Peak Gastroenterology Associates | Colorado Springs | Colorado |
| United States | Local Institution - 164 | Columbia | Maryland |
| United States | AES - DRS - Synexus Clinical Research US, Inc. - Columbus | Columbus | Ohio |
| United States | Optimed Research Ltd | Columbus | Ohio |
| United States | Childrens Medical Center | Dallas | Texas |
| United States | Local Institution - 148 | Dallas | Texas |
| United States | Rocky Mountain Pediatric Gastroenterology | Denver | Colorado |
| United States | Intermountain Clinical Research | Draper | Utah |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University Of Connecticut | Farmington | Connecticut |
| United States | Local Institution - 046 | Florence | Kentucky |
| United States | GI Associates and Endoscopy Center-GI Clinical Research Department | Flowood | Mississippi |
| United States | Brooke Army Medical Center Francis Street Medical Center | Fort Sam Houston | Texas |
| United States | Cook Childrens Medical Center | Fort Worth | Texas |
| United States | Greater Boston Gastroenterology PC | Framingham | Massachusetts |
| United States | Woodholme Gastroenterology Associates | Glen Burnie | Maryland |
| United States | Local Institution - 028 | Great Neck | New York |
| United States | Local Institution - 131 | Greensboro | North Carolina |
| United States | Prisma Health - Upstate | Greenville | South Carolina |
| United States | Illinois Gastroenterology Group- Gurnee (GI Allian | Gurnee | Illinois |
| United States | Local Institution - 012 | Hagerstown | Maryland |
| United States | Medical Research Center of Connecticut LLC | Hamden | Connecticut |
| United States | Drug Trials America | Hartsdale | New York |
| United States | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Houston Endoscopy and Research Center | Houston | Texas |
| United States | Grand Teton Research Group PLLC | Idaho Falls | Idaho |
| United States | Indiana University (IU) Health Physicians - IU Health Neuroscience Center | Indianapolis | Indiana |
| United States | Nature Coast Clinical Research LLC | Inverness | Florida |
| United States | University Of Iowa Hospitals And Clinics | Iowa City | Iowa |
| United States | ENCORE Borland-Groover Clinical Research | Jacksonville | Florida |
| United States | Mid America Gastrointestinal Consultants | Kansas City | Missouri |
| United States | University Of Kansas Medical Center | Kansas City | Kansas |
| United States | Atlantic Medical Group - Kinston - CAR | Kinston | North Carolina |
| United States | OM Research | Lancaster | California |
| United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Emeritas Research Group | Leesburg | Virginia |
| United States | Local Institution - 170 | Littleton | Colorado |
| United States | GastroIntestinal Biosciences | Los Angeles | California |
| United States | University Of Louisville | Louisville | Kentucky |
| United States | Blue Ridge Medical Research | Lynchburg | Virginia |
| United States | Gastroenterology Associates Of Central Georgia LLC | Macon | Georgia |
| United States | University Of Wisconsin | Madison | Wisconsin |
| United States | Velocity Clinical Research - Grants Pass - ERN - PPDS | Medford | Oregon |
| United States | Clinical Trials Management LLC | Metairie | Louisiana |
| United States | Clinical Trials Management LLC | Metairie | Louisiana |
| United States | A Plus Research Inc | Miami | Florida |
| United States | Homestead Associates in Research Inc | Miami | Florida |
| United States | Aurora Saint Lukes Medical Center | Milwaukee | Wisconsin |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | Gastroenterology Health Partners PLLC | New Albany | Indiana |
| United States | Ochsner Children's Health Center | New Orleans | Louisiana |
| United States | Columbia Presbyterian Medical Center | New York | New York |
| United States | Dr. Jeffrey Crespin, MD - New York - CAR | New York | New York |
| United States | Icahn School Of Medicine At Mount Sinai | New York | New York |
| United States | Lenox Hill Hospital | New York | New York |
| United States | NYU Langone Medical Center | New York | New York |
| United States | Arkansas Gastroenterology, P.A. | North Little Rock | Arkansas |
| United States | Med-Care Research | North Miami Beach | Florida |
| United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
| United States | Atlantic Research Center LLC | Ocean City | New Jersey |
| United States | Advanced Research Institute-South Ogden | Ogden | Utah |
| United States | Ogden Clinic Gastrenterology - CAR | Ogden | Utah |
| United States | Local Institution - 166 | Oklahoma City | Oklahoma |
| United States | University Of Nebraska Medical Center | Omaha | Nebraska |
| United States | Arnold Palmer Hospital For Children | Orlando | Florida |
| United States | Gastroenterology Consultants of Central Florida - CAR | Orlando | Florida |
| United States | Local Institution - 146 | Orlando | Florida |
| United States | Palmtree Clinical Research | Palm Springs | California |
| United States | The Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University - Clinical Research Institute | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
| United States | Local Institution - 147 | Phoenix | Arizona |
| United States | Phoenix Childrens Hospital | Phoenix | Arizona |
| United States | Local Institution - 169 | Pinellas Park | Florida |
| United States | Asthma, Allergy Care Center of Florida | Plantation | Florida |
| United States | Minnesota Gastroenterology | Plymouth | Minnesota |
| United States | Advanced Medical Research Center | Port Orange | Florida |
| United States | Glenn S Freed, DO - CAR | Pottsville | Pennsylvania |
| United States | Alliance Clinical Research, LLC | Poway | California |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Advanced Research Institute - Reno | Reno | Nevada |
| United States | McGuire Veterans Affairs Medical Center | Richmond | Virginia |
| United States | Carilion Clinic | Roanoke | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Rochester Gastroenterology: Devgun Surinder MD | Rochester | New York |
| United States | Digestive Health Associates of Texas (DHAT) | Rockwell | Texas |
| United States | Washington University Siteman Cancer Center | Saint Louis | Missouri |
| United States | University of Utah Primary Children's Medical Center | Salt Lake City | Utah |
| United States | University Of Utah School Of Medicine | Salt Lake City | Utah |
| United States | Southern Star Research Institute LLC | San Antonio | Texas |
| United States | Precision Research Institute, Llc | San Diego | California |
| United States | SDG Clinical Research, Inc. | San Diego | California |
| United States | Granite Peaks Gastroenterology | Sandy | Utah |
| United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
| United States | FC Research LLC | South Dartmouth | Massachusetts |
| United States | Texas Digestive Disease Consultants - Southlake | Southlake | Texas |
| United States | Velocity Clinical Research - Spokane - ERN - PPDS | Spokane | Washington |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | US Associates in Research Inc | Sweetwater | Florida |
| United States | Hill Medical Center | Syracuse | New York |
| United States | Syracuse VA Medical Center | Syracuse | New York |
| United States | Clinical Research Institute of Michigan | Troy | Michigan |
| United States | Del Sol Research Management | Tucson | Arizona |
| United States | MetroHealth Medical Center | Tucson | Arizona |
| United States | Gastro Care PC - CAR | Tuscaloosa | Alabama |
| United States | Tyler Research Institute, LLC | Tyler | Texas |
| United States | Vancouver Clinic Inc PS | Vancouver | Washington |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Western States Clinical Research Inc | Wheat Ridge | Colorado |
| United States | Local Institution - 009 | Worcester | Massachusetts |
| United States | Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | 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. | For a minimum of 28 months | |
| Secondary | Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies | This includes neutralizing antibodies when warranted. | For a minimum of 28 months |
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