Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04991935
Collaborator
(none)
259
301
1
60.1
0.9
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
259 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Sep 14, 2021
Anticipated Primary Completion Date
:
Sep 17, 2026
Anticipated Study Completion Date
:
Sep 17, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-93538 Participants are administered CC-93538 dose subcutaneously once weekly |
Drug: CC-93538
CC-93538
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies [For a minimum of 28 months]
This includes neutralizing antibodies when warranted.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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.
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AES - DRS - Simon Williamson Clinic, PC - Birmingham | Birmingham | Alabama | United States | 35211-1320 |
| 2 | Gastro Care PC - CAR | Tuscaloosa | Alabama | United States | 35406 |
| 3 | Gastro Care PC - CAR | Tuscaloosa | Alabama | United States | 35406 |
| 4 | Phoenix Childrens Hospital | Phoenix | Arizona | United States | 85016 |
| 5 | AES - DRS - Central Phoenix Medical Clinic, LLC | Phoenix | Arizona | United States | 85020-4348 |
| 6 | Mayo Clinic Scottsdale | Scottsdale | Arizona | United States | 85259 |
| 7 | Del Sol Research Management | Tucson | Arizona | United States | 85715 |
| 8 | MetroHealth Medical Center | Tucson | Arizona | United States | 85723-0001 |
| 9 | OM Research | Lancaster | California | United States | 93534 |
| 10 | OM Research | Lancaster | California | United States | 93534 |
| 11 | Gastrointestinal Biosciences | Los Angeles | California | United States | 90067 |
| 12 | UCSF Benioff Children's Hospital Oakland | Oakland | California | United States | 94609 |
| 13 | Palmtree Clinical Research | Palm Springs | California | United States | 92262 |
| 14 | Palmtree Clinical Research | Palm Springs | California | United States | 92262 |
| 15 | Alliance Clinical Research, LLC | Poway | California | United States | 92064-2021 |
| 16 | SDG Clinical Research, Inc. | San Diego | California | United States | 92103-5639 |
| 17 | Precision Research Institute, LLC | San Diego | California | United States | 92114 |
| 18 | Childrens Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 19 | Peak Gastroenterology Associates | Colorado Springs | Colorado | United States | 80907 |
| 20 | Rocky Mountain Pediatric Gastroenterology | Denver | Colorado | United States | 80218 |
| 21 | Western States Clinical Research Inc | Wheat Ridge | Colorado | United States | 80033 |
| 22 | Western States Clinical Research Inc | Wheat Ridge | Colorado | United States | 80033 |
| 23 | Connecticut Clinical Research Foundation | Bristol | Connecticut | United States | 06010 |
| 24 | University of Connecticut | Farmington | Connecticut | United States | 06030 |
| 25 | Medical Research Center of Connecticut LLC | Hamden | Connecticut | United States | 06518 |
| 26 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 27 | Gastro Florida | Clearwater | Florida | United States | 33756-3839 |
| 28 | Nature Coast Clinical Research LLC | Inverness | Florida | United States | 34452 |
| 29 | Nature Coast Clinical Research LLC | Inverness | Florida | United States | 34452 |
| 30 | ENCORE Borland-Groover Clinical Research | Jacksonville | Florida | United States | 32256 |
| 31 | ENCORE Borland-Groover Clinical Research | Jacksonville | Florida | United States | 32256 |
| 32 | Homestead Associates in Research Inc | Miami | Florida | United States | 33032 |
| 33 | A Plus Research Inc | Miami | Florida | United States | 33144-2035 |
| 34 | Med-Care Research | North Miami Beach | Florida | United States | 33162 |
| 35 | AES - DRS - Synexus Clinical Research US, Inc. - Orlando | Orlando | Florida | United States | 32806-1041 |
| 36 | Arnold Palmer Hospital For Children | Orlando | Florida | United States | 32806 |
| 37 | Gastroenterology Consultants of Central Florida - CAR | Orlando | Florida | United States | 32825 |
| 38 | Advanced Medical Research Center | Port Orange | Florida | United States | 32127 |
| 39 | US Associates in Research Inc | Sweetwater | Florida | United States | 33172-2741 |
| 40 | Emory University | Atlanta | Georgia | United States | 30322 |
| 41 | Gastroenterology Associates Of Central Georgia LLC | Macon | Georgia | United States | 31201 |
| 42 | Gastroenterology Associates Of Central Georgia LLC | Macon | Georgia | United States | 31201 |
| 43 | Grand Teton Research Group PLLC | Idaho Falls | Idaho | United States | 83404 |
| 44 | Northwestern University Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 45 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 46 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 47 | Gastroenterology Health Partners PLLC | New Albany | Indiana | United States | 47150 |
| 48 | Gastroenterology Health Partners PLLC | New Albany | Indiana | United States | 47150 |
| 49 | Iowa Digestive Disease Center | Clive | Iowa | United States | 50325 |
| 50 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 51 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 52 | Tri-State Gastroentrology Associates | Florence | Kentucky | United States | 41042 |
| 53 | University of Louisville | Louisville | Kentucky | United States | 40202 |
| 54 | Gastroenterology Associates LLC | Baton Rouge | Louisiana | United States | 70809 |
| 55 | Clinical Trials Management LLC | Metairie | Louisiana | United States | 70006 |
| 56 | Clinical Trials Management LLC | Metairie | Louisiana | United States | 70006 |
| 57 | Clinical Trials Management LLC | Metairie | Louisiana | United States | 70006 |
| 58 | Ochsner Children's Health Center | New Orleans | Louisiana | United States | 70121 |
| 59 | Ochsner Children's Health Center | New Orleans | Louisiana | United States | 70121 |
| 60 | Johns Hopkins University | Baltimore | Maryland | United States | 21224 |
| 61 | Digestive Disease Associates, PA | Catonsville | Maryland | United States | 21228 |
| 62 | Woodholme Gastroenterology Associates | Glen Burnie | Maryland | United States | 21061 |
| 63 | Woodholme Gastroenterology Associates | Glen Burnie | Maryland | United States | 21061 |
| 64 | Meritus Medical Center | Hagerstown | Maryland | United States | 21742 |
| 65 | Tufts - New England Medical Center | Boston | Massachusetts | United States | 02111 |
| 66 | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
| 67 | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
| 68 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 69 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 70 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 71 | Greater Boston Gastroenterology PC | Framingham | Massachusetts | United States | 01702 |
| 72 | FC Research LLC | South Dartmouth | Massachusetts | United States | 02747 |
| 73 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 74 | UMASS Memorial Hospital | Worcester | Massachusetts | United States | 01655 |
| 75 | Troy Gastroenterology | Troy | Michigan | United States | 48098 |
| 76 | Gastroenterology Associates of Western Michigan PLC | Wyoming | Michigan | United States | 49519 |
| 77 | Minnesota Gastroenterology | Plymouth | Minnesota | United States | 55446 |
| 78 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 79 | GI Associates and Endoscopy Center-GI Clinical Research Department | Flowood | Mississippi | United States | 39232 |
| 80 | Mid America Gastrointestinal Consultants | Kansas City | Missouri | United States | 64111 |
| 81 | Mid America Gastrointestinal Consultants | Kansas City | Missouri | United States | 64111 |
| 82 | Washington University Siteman Cancer Center | Saint Louis | Missouri | United States | 63110 |
| 83 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-6805 |
| 84 | Advanced Research Institute - Reno | Reno | Nevada | United States | 89511-2060 |
| 85 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 86 | Atlantic Research Center LLC | Ocean City | New Jersey | United States | 07712 |
| 87 | New Mexico Clinical Research and Osteoporosis Center | Albuquerque | New Mexico | United States | 87106-4725 |
| 88 | Long Island Gastrointestinal Research Group LLP | Great Neck | New York | United States | 11023 |
| 89 | Drug Trials America | Hartsdale | New York | United States | 10530 |
| 90 | NYU Langone Medical Center | New York | New York | United States | 10016 |
| 91 | Dr. Jeffrey Crespin, MD - New York - CAR | New York | New York | United States | 10017-2009 |
| 92 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 93 | Columbia Presbyterian Medical Center | New York | New York | United States | 10032-3725 |
| 94 | Rochester Gastroenterology: Devgun Surinder MD | Rochester | New York | United States | 14625 |
| 95 | Hill Medical Center | Syracuse | New York | United States | 13210 |
| 96 | Syracuse VA Medical Center | Syracuse | New York | United States | 13210 |
| 97 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 98 | Clinical Research of Charlotte | Charlotte | North Carolina | United States | 28277 |
| 99 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 100 | Medication Management LLC | Greensboro | North Carolina | United States | 27405-6950 |
| 101 | Atlantic Medical Group - Kinston - CAR | Kinston | North Carolina | United States | 28501-3851 |
| 102 | Dayton Gastroenterology, Inc | Beavercreek | Ohio | United States | 45440-3237 |
| 103 | Consultants for Clinical Research | Cincinnati | Ohio | United States | 45219 |
| 104 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 105 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45267 |
| 106 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 107 | The Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 108 | AES - DRS - Synexus Clinical Research US, Inc. - Columbus | Columbus | Ohio | United States | 43212-3119 |
| 109 | Optimed Research Ltd | Columbus | Ohio | United States | 43235 |
| 110 | Optimed Research Ltd | Columbus | Ohio | United States | 43235 |
| 111 | Velocity Clinical Research - Grants Pass - ERN - PPDS | Medford | Oregon | United States | 97504-9741 |
| 112 | Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 113 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104-978 |
| 114 | University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | United States | 19104 |
| 115 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 116 | Glenn S Freed, DO - CAR | Pottsville | Pennsylvania | United States | 17901-3636 |
| 117 | University Gastroenterology | Providence | Rhode Island | United States | 02905 |
| 118 | AES - DRS - Synexus Clinical Research US, Inc. - Anderson | Anderson | South Carolina | United States | 29621-2062 |
| 119 | Prisma Health - Upstate | Greenville | South Carolina | United States | 29615 |
| 120 | Prisma Health - Upstate | Greenville | South Carolina | United States | 29615 |
| 121 | ClinSearch LLC | Chattanooga | Tennessee | United States | 37421 |
| 122 | Vanderbilt University | Nashville | Tennessee | United States | 37212 |
| 123 | Texas Digestive Disease Consultants Dallas | Cedar Park | Texas | United States | 78613 |
| 124 | AES - DRS - Synexus Clinical Research US, Inc. - Dallas | Dallas | Texas | United States | 75234-7858 |
| 125 | Childrens Medical Center | Dallas | Texas | United States | 75235 |
| 126 | Childrens Medical Center | Dallas | Texas | United States | 75235 |
| 127 | Brooke Army Medical Center Francis Street Medical Center | Fort Sam Houston | Texas | United States | 78235-8200 |
| 128 | Cook Childrens Medical Center | Fort Worth | Texas | United States | 76104 |
| 129 | Houston Endoscopy and Research Center | Houston | Texas | United States | 77079 |
| 130 | Digestive Health Associates of Texas (DHAT) | Rockwell | Texas | United States | 75032 |
| 131 | Southern Star Research Institute LLC | San Antonio | Texas | United States | 78229 |
| 132 | Texas Digestive Disease Consultants - Southlake | Southlake | Texas | United States | 76092 |
| 133 | Texas Digestive Disease Consultants - Southlake | Southlake | Texas | United States | 76092 |
| 134 | Tyler Research Institute, LLC | Tyler | Texas | United States | 75701 |
| 135 | Tyler Research Institute, LLC | Tyler | Texas | United States | 75701 |
| 136 | Intermountain Clinical Research | Draper | Utah | United States | 84020-5645 |
| 137 | Ogden Clinic Gastrenterology - CAR | Ogden | Utah | United States | 84403-3323 |
| 138 | Advanced Research Institute-South Ogden | Ogden | Utah | United States | 84405 |
| 139 | University of Utah Primary Children's Medical Center | Salt Lake City | Utah | United States | 84132 |
| 140 | University of Utah School of Medicine | Salt Lake City | Utah | United States | 84132 |
| 141 | University of Vermont Medical Center Gastro | Burlington | Vermont | United States | 05401 |
| 142 | University of Vermont Medical Center Gastro | Burlington | Vermont | United States | 05401 |
| 143 | Emeritas Research Group | Leesburg | Virginia | United States | 20176 |
| 144 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
| 145 | McGuire Veterans Affairs Medical Center | Richmond | Virginia | United States | 23249 |
| 146 | Carilion Clinic | Roanoke | Virginia | United States | 24013 |
| 147 | Velocity Clinical Research - Spokane - ERN - PPDS | Spokane | Washington | United States | 99204 |
| 148 | Vancouver Clinic Inc PS | Vancouver | Washington | United States | 98664 |
| 149 | Vancouver Clinic Inc PS | Vancouver | Washington | United States | 98664 |
| 150 | University of Wisconsin | Madison | Wisconsin | United States | 53792 |
| 151 | Aurora Saint Lukes Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 152 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 153 | Gastroenterology Associates, PC - Casper - CAR | Casper | Wyoming | United States | 10456 |
| 154 | Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | C1199ABB | |
| 155 | Gedyt | BuenosAires | Argentina | C1125ABE | |
| 156 | Centro de Investigaciones Medica Mar del Plata | Mar Del Plata | Argentina | B7600DHK | |
| 157 | Local Institution - 695 | Mar Del Plata | Argentina | B7600DHK | |
| 158 | Instituto CER S.A. | Quilmes | Argentina | B1878DVB | |
| 159 | Local Institution - 696 | Quilmes | Argentina | B1878DVB | |
| 160 | Investigaciones En Patologias Respiratorias | San Miguel de Tucumán | Argentina | T4000IAR | |
| 161 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
| 162 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 163 | Local Institution - 554 | Liverpool | New South Wales | Australia | 2170 |
| 164 | The Childrens Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 165 | Coastal Digestive Health | Maroorchydore | Queensland | Australia | 4558 |
| 166 | Coral Sea Clinical Research Institute | North Mackay | Queensland | Australia | 4740 |
| 167 | Mater Adult Hospital | South Brisbane | Queensland | Australia | 4101 |
| 168 | Local Institution - 542 | Woolloongabba | Queensland | Australia | 4102 |
| 169 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 170 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 171 | Lyell McEwin Hospital | Elizabeth Vale | South Australia | Australia | 5112 |
| 172 | Monash Health, Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
| 173 | Footscray Hospital | Footscray | Victoria | Australia | 3011 |
| 174 | Local Institution - 543 | Footscray | Victoria | Australia | 3011 |
| 175 | Local Institution - 539 | Melbourne | Victoria | Australia | 3004 |
| 176 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 177 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | 6150 |
| 178 | St Vincents Hospital Melbourne | Fitzroy | Australia | 3065 | |
| 179 | Local Institution - 547 | Western Australia | Australia | 6056 | |
| 180 | St John of God Midland Hospital | Western Australia | Australia | 6056 | |
| 181 | Krankenhaus der Barmherzigen Brüder Eisenstadt | Burgenland | Austria | 7000 | |
| 182 | LKH-Universitätsklinikum Klinikum Graz | Graz | Austria | 8036 | |
| 183 | Hospital of Barmherzige Schwestern Linz | Linz | Austria | 4010 | |
| 184 | Local Institution - 435 | Vienna | Austria | 1090 | |
| 185 | Medizinische Universitat Wien | Vienna | Austria | 1090 | |
| 186 | UZ Brussel | Brussels | Belgium | 1090 | |
| 187 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 188 | UZ Leuven | Leuven | Belgium | 3000 | |
| 189 | AZ Sint-Lucas Brugge | West-Vlaanderen | Belgium | 8310 | |
| 190 | University of Calgary | Calgary | Alberta | Canada | T2N 2T9 |
| 191 | University of Alberta | Edmonton | Alberta | Canada | T6G2V2 |
| 192 | South Edmonton Gastroenterology | Edmonton | Alberta | Canada | T6L 6K3 |
| 193 | GI Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 194 | PerCuro Clinical Research LTD | Victoria | British Columbia | Canada | V8V3M9 |
| 195 | Ottawa Allergy Research Corporation | Ottawa | Ontario | Canada | K1Y 4G2 |
| 196 | Local Institution - 204 | Toronto | Ontario | Canada | M5T 2S8 |
| 197 | Toronto Western Hospital | Toronto | Ontario | Canada | M5T 2S8 |
| 198 | Toronto Digestive Disease Associates Inc | Vaughan | Ontario | Canada | L4L 4Y7 |
| 199 | Staedisches Klinikum Brandenburg | Brandenburg an der Havel | Germany | 14770 | |
| 200 | AES - DRS - Synexus Frankfurt Research Centre | Frankfurt am Main | Germany | 60313 | |
| 201 | Local Institution - 339 | Frankfurt am Main | Germany | 60313 | |
| 202 | Klinikum Garmisch-Partenkirchen Gmbh | Garmisch-Partenkirchen | Germany | 82467 | |
| 203 | Facharztzentrum Eppendorf | Hamburg | Germany | 20249 | |
| 204 | Universitatsklinikum Leipzig | Leipzig | Germany | 04103 | |
| 205 | EUGASTRO GmbH | Leipzig | Germany | 4103 | |
| 206 | Gastroenterologische Gemeinschaftspraxis Mainz | Mainz | Germany | 55122 | |
| 207 | Klinikum rechts der Isar der Technischen Universitaet Muenchen | Munchen | Germany | 81675 | |
| 208 | Praxis Prof. Herbert Kellner | München | Germany | 80639 | |
| 209 | Rambam Medical Center | Haifa | Israel | 35254 | |
| 210 | Edith Wolfson Medical Center | Holon | Israel | 5822012 | |
| 211 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
| 212 | Hadassah Medical Center | Jerusalem | Israel | 91120 | |
| 213 | Local Institution - 282 | Jerusalem | Israel | 91120 | |
| 214 | Local Institution - 278 | Tel-Aviv | Israel | 64239 | |
| 215 | Tel-Aviv Sourasky Medical Center | Tel-Aviv | Israel | 64239 | |
| 216 | Shamir Medical Center - Assaf Harofeh | Zerifin | Israel | 70300 | |
| 217 | Ospedale Policlinico San Martino | Genova | Italy | 16132 | |
| 218 | Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
| 219 | Local Institution - 254 | Milano | Italy | 20122 | |
| 220 | AOU dell'Università degli Studi della Campania Luigi Vanvitelli | Napoli | Italy | 80131 | |
| 221 | Local Institution - 256 | Napoli | Italy | 80131 | |
| 222 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 223 | Azienda Ospedaliera Universitaria Pisana | Pisa | Italy | 56100 | |
| 224 | Azienda Policlinico Umberto I | Rome | Italy | 00161 | |
| 225 | Local Institution - 253 | Rome | Italy | 00161 | |
| 226 | Akita University Hospital | Akita-shi | Japan | 010-8543 | |
| 227 | Nippon Medical School Hospital | Bunkyo-ku | Japan | 113-8602 | |
| 228 | Tokai University Hospital | Isehara City, Kanagawa | Japan | 259-1193 | |
| 229 | Kobe University Hospital | Kobe | Japan | 650-0017 | |
| 230 | Local Institution - 597 | Kobe | Japan | 650-0017 | |
| 231 | Gunma University Hospital | Maebashi | Japan | 371-8511 | |
| 232 | Daido Clinic | Nagoya | Japan | 457-8511 | |
| 233 | Nagoya City University Hospital | Nagoya | Japan | 467-8602 | |
| 234 | Niigata University Medical and Dental Hospital | Niigata-shi | Japan | 951-8510 | |
| 235 | Hyogo College of Medicine Hospital | Nishinomiya | Japan | 663-8501 | |
| 236 | Local Institution - 600 | Nishinomiya | Japan | 663-8501 | |
| 237 | Kawasaki Medical School Hospital | Okayama-Shi | Japan | 700-8505 | |
| 238 | Local Institution - 603 | Okayama-Shi | Japan | 700-8505 | |
| 239 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
| 240 | Gunma Children's Medical Center | Shibukawa | Japan | 377-8577 | |
| 241 | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-Ku | Japan | 162-8655 | |
| 242 | International University of Health and Werfare Mita Hospital | Tokyo | Japan | 108-8329 | |
| 243 | Local Institution - 605 | Tokyo | Japan | 108-8329 | |
| 244 | National Center for Child Health and Development | Tokyo | Japan | 157-8535 | |
| 245 | Fujita Health University Hospital | Toyoake | Japan | 470-1192 | |
| 246 | Local Institution - 596 | Toyoake | Japan | 470-1192 | |
| 247 | Local Institution - 590 | Yamagata | Japan | 990-9585 | |
| 248 | Yamagata University Hospital | Yamagata | Japan | 990-9585 | |
| 249 | Local Institution - 385 | Bydgoszcz | Poland | 85-079 | |
| 250 | Vitamed Galaj i Cichomski sp.j. | Bydgoszcz | Poland | 85-079 | |
| 251 | AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Czestochowa | Poland | 42-202 | |
| 252 | Local Institution - 389 | Czestochowa | Poland | 42-202 | |
| 253 | AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | Poland | 80-382 | |
| 254 | Local Institution - 390 | Gdansk | Poland | 80-382 | |
| 255 | AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | Poland | 40-040 | |
| 256 | Local Institution - 388 | Katowice | Poland | 40-040 | |
| 257 | AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi | Lódz | Poland | 90-127 | |
| 258 | Local Institution - 392 | Lódz | Poland | 90-127 | |
| 259 | TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC | Szczecin | Poland | 71-270 | |
| 260 | Local Institution - 383 | Warsaw | Poland | 00-728 | |
| 261 | WIP Warsaw IBD Point | Warsaw | Poland | 00-728 | |
| 262 | Centrum Zdrowia MDM | Warszawa | Poland | 00-635 | |
| 263 | Local Institution - 387 | Warszawa | Poland | 00-635 | |
| 264 | AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | Poland | 01-192 | |
| 265 | Local Institution - 393 | Warszawa | Poland | 01-192 | |
| 266 | AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | Poland | 50-088 | |
| 267 | Local Institution - 391 | Wroclaw | Poland | 50-088 | |
| 268 | Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego | Wroclaw | Poland | 50-556 | |
| 269 | Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland | 51-162 | |
| 270 | Local Institution - 384 | Wroclaw | Poland | 51-162 | |
| 271 | Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos | Lisboa | Portugal | 1069-639 | |
| 272 | Centro Hospitalar Lisboa Central- Hospital Dona Estefânia | Lisboa | Portugal | 1169-045 | |
| 273 | Local Institution - 307 | Lisboa | Portugal | 1169-045 | |
| 274 | Local Institution - 305 | Lisboa | Portugal | 1649-035 | |
| 275 | Centro Hospitalar do Porto - Hospital de Santo António | Porto | Portugal | 4099 - 001 | |
| 276 | Centro Hospitalar de São João, E.P.E. | Porto | Portugal | 4200-319 | |
| 277 | Local Institution - 308 | Porto | Portugal | 4200-319 | |
| 278 | Hospital Clinic de Barcelona | Barcelona | Spain | 08036 | |
| 279 | Hospital Universitario Reina Sofia | Cordoba | Spain | 14001 | |
| 280 | Hospital La Princesa | Madrid | Spain | 28006 | |
| 281 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 282 | Local Institution - 413 | Madrid | Spain | 28046 | |
| 283 | Hospital Costa del Sol | Marbella | Spain | 29603 | |
| 284 | Hospital Virgen del Rocio | Sevilla | Spain | 41013 | |
| 285 | Chuv Bh-04 | Lausanne | Switzerland | 1011 | |
| 286 | Kantonsspital Liestal | Liestal | Switzerland | 4410 | |
| 287 | Belfast Health and Social Care Trust | Belfast Northern Ireland | United Kingdom | BT9 7AB | |
| 288 | AES - DRS - Synexus Midlands Clinical Research Centre | Birmingham | United Kingdom | B15 2SQ | |
| 289 | Local Institution - 231 | Birmingham | United Kingdom | B15 2SQ | |
| 290 | Addenbrooke's Hospital | Cambridge | United Kingdom | CB2 2 QQ | |
| 291 | AES - DRS - Synexus Wales Clinical Research Centre | Cardiff | United Kingdom | CF15 9SS | |
| 292 | Local Institution - 234 | Cardiff | United Kingdom | CF15 9SS | |
| 293 | AES - DRS - NW Consortium Lancashire | Chorley | United Kingdom | PR7 7NA | |
| 294 | AES - DRS - Synexus North Teesside Clinical Research Centre | Hardwick | United Kingdom | TS19 8PE | |
| 295 | AES - DRS - Synexus Hexham Clinical Research Centre | Hexam | United Kingdom | NE46 1QJ | |
| 296 | Local Institution - 233 | Hexam | United Kingdom | NE46 1QJ | |
| 297 | AES - DRS - NW Consortium Merseyside | Liverpool | United Kingdom | L22 0LG | |
| 298 | Local Institution - 236 | Liverpool | United Kingdom | L22 0LG | |
| 299 | Royal Manchester Children's Hospital | Manchester | United Kingdom | M13 9WL | |
| 300 | AES - DRS - NW Consortium Manchester | Manchester | United Kingdom | M15 6SX | |
| 301 | Southampton General Hospital | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT04991935
Other Study ID Numbers:
- CC-93538-EE-002
- 2020-004335-24
First Posted:
Aug 5, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celgene
Additional relevant MeSH terms: