Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03440372
Collaborator
(none)
600
565
2
76
1.1
0

Study Details

Study Description

Brief Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date :
Feb 27, 2018
Anticipated Primary Completion Date :
Mar 22, 2024
Anticipated Study Completion Date :
Jun 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Administration of oral Ozanimod

Drug: Ozanimod
Specified dose on specified days

Placebo Comparator: Administration of Placebo

Other: Placebo
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 [Week 12]

Secondary Outcome Measures

  1. Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline [Week 12]

  2. Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [Week 12]

  3. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [Week 12]

  4. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [Week 12]

  5. Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [Week 12]

  6. Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points [Week 12]

  7. Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% [Week 12]

  8. Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes) [Week 12]

  9. Proportion of participants with CDAI reduction from baseline of ≥ 70 points [Week 12]

  10. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [Week 12]

  11. Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Crohn's disease for ≥ 3 months on endoscopy and on histological exam

  • Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies

  • Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450

  • An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points

  • Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:
  • Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention

  • Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition

  • Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Holland Center for Family Health Peoria Arizona United States 85381
2 Elite Clinical Studies, LLC Phoenix Arizona United States 85018
3 Arkansas Gastroenterology, P.A. North Little Rock Arkansas United States 72117
4 Arkansas Gastroenterology, P.A. North Little Rock Arkansas United States 72117
5 Sharp Chula Vista Medical Center Chula Vista California United States 91911
6 Sharp Chula Vista Medical Center Chula Vista California United States 91911
7 Valley View Internal Medicine Garden Grove California United States 92843
8 Valley View Internal Medicine Garden Grove California United States 92843
9 San Diego Clinical Trials La Mesa California United States 91942
10 Children's Hospital of Los Angeles Los Angeles California United States 90027
11 Children's Hospital Of Los Angeles Los Angeles California United States 90027
12 Gastrointestinal Biosciences Los Angeles California United States 90067
13 VA Northern California Health Care System Mather California United States 95655
14 ABS Health, LLC Mission Viejo California United States 92691
15 Alliance Clinical Research Oceanside California United States 92056
16 Palo Alto Center-Palo Alto Medical Foundation Research Institute Palo Alto California United States 94304
17 Inland Empire Liver Foundation Rialto California United States 92377
18 Inland Empire Liver Foundation Rialto California United States 92377
19 Medical Associates Research Group San Diego California United States 92123
20 Medical Associates Research Group San Diego California United States 92123
21 Childrens Hospital Colorado Aurora Colorado United States 80045
22 Yale University New Haven Connecticut United States 06510
23 Yale University New Haven Connecticut United States 06510
24 Gastro Florida Clearwater Florida United States 33756-3839
25 Gastro Florida Clearwater Florida United States 33756-3839
26 University of Florida Health Endocrinology - Medical Specialties - Medical Plaza Gainesville Florida United States 32608
27 University of Florida Health Endocrinology - Medical Specialties - Medical Plaza Gainesville Florida United States 32608
28 Qway Research LLC Hialeah Florida United States 33010
29 Qway Research LLC Hialeah Florida United States 33010
30 Floridian Clinical Research LLC Hialeah Florida United States 33016
31 Floridian Clinical Research LLC Hialeah Florida United States 33016
32 Harmony Medical Research Institute Hialeah Florida United States 33016
33 The Center for Gastrointestinal Disorders Hollywood Florida United States 33021
34 The Center for Gastrointestinal Disorders Hollywood Florida United States 33021
35 Vista Health Research Homestead Florida United States 33033
36 Vista Health Research Homestead Florida United States 33033
37 Florida Center for Gastroenterology Largo Florida United States 33777
38 Florida Center for Gastroenterology Largo Florida United States 33777
39 Nova Clinical Research Center LLC Miami Florida United States 33125
40 Nova Clinical Research Center LLC Miami Florida United States 33125
41 LCC Medical Research Institute, LLC Miami Florida United States 33126
42 Research Associates of South Florida LLC Miami Florida United States 33156
43 Research Associates of South Florida LLC Miami Florida United States 33156
44 Advanced Research for Health Improvement Naples Florida United States 34109
45 Advanced Research for Health Improvement Naples Florida United States 34109
46 NSB Research New Smyrna Beach Florida United States 32168
47 NSB Research New Smyrna Beach Florida United States 32168
48 HMD Research LLC Orlando Florida United States 32819
49 HMD Research LLC Orlando Florida United States 32819
50 Advanced Medical Research Center Port Orange Florida United States 32127
51 Advanced Medical Research Center Port Orange Florida United States 32127
52 Asclepes Research Centers Weeki Wachee Florida United States 34607
53 Asclepes Research Centers Weeki Wachee Florida United States 34607
54 Consultative Gastroenterology Atlanta Georgia United States 30308
55 Consultative Gastroenterology Atlanta Georgia United States 30308
56 Atlanta Gastroenterology Associates, LLC Atlanta Georgia United States 30342
57 Atlanta Gastroenterology Associates, Llc Atlanta Georgia United States 30342
58 Children's Center for Digestive Healthcare Atlanta Georgia United States 30342
59 Children's Center for Digestive Healthcare Atlanta Georgia United States 30342
60 Gastrointestinal Disease Research Columbus Georgia United States 31904
61 Gastrointestinal Disease Research Columbus Georgia United States 31904
62 Gastroenterology Associates Of Central Georgia LLC Macon Georgia United States 31201
63 Gastroenterology Associates Of Central Georgia LLC Macon Georgia United States 31201
64 Rush University Medical Center - University Cardiovascular Surgeons Chicago Illinois United States 60612
65 Northwestern University Chicago Illinois United States 60622
66 Northwestern University Chicago Illinois United States 60622
67 Carle Foundation Hospital Urbana Illinois United States 61801
68 Carle Foundation Hospital Urbana Illinois United States 61801
69 Iowa Digestive Disease Center Clive Iowa United States 50325
70 University of Kentucky Health Care Lexington Kentucky United States 40536
71 University of Kentucky Health Care Lexington Kentucky United States 40536
72 CroNOLA LLC Houma Louisiana United States 70360
73 Centex Studies, Inc. Lake Charles Louisiana United States 70601
74 Centex Studies, Inc. Lake Charles Louisiana United States 70601
75 Nola Research Works New Orleans Louisiana United States 70125
76 Nola Research Works New Orleans Louisiana United States 70125
77 LSU Health Sciences Center Shreveport Shreveport Louisiana United States 71103
78 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
79 Digestive Disease Associates, PA Catonsville Maryland United States 21228
80 Woodholme Gastroenterology Associates Glen Burnie Maryland United States 21061
81 Woodholme Gastroenterology Associates Glen Burnie Maryland United States 21061
82 Brigham and Women's Hospital - Crohn's and Colitis Center Chestnut Hill Massachusetts United States 02467
83 Brigham and Women's Hospital - Crohn's and Colitis Center Chestnut Hill Massachusetts United States 02467
84 Baystate Medical Center Springfield Massachusetts United States 01199
85 Local Institution - 286 Springfield Massachusetts United States 01199
86 Medex Research Institute Caro Michigan United States 48723
87 Medex Research Institute Caro Michigan United States 48723
88 Revive Research Institute Southfield Michigan United States 48034
89 Revive Research Institute Southfield Michigan United States 48034
90 Southern Therapy and Advanced Research Jackson Mississippi United States 39216
91 Southern Therapy and Advanced Research Jackson Mississippi United States 39216
92 Washington University School of Medicine Saint Louis Missouri United States 63110
93 Washington University School Of Medicine Saint Louis Missouri United States 63110
94 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
95 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
96 University of New Mexico Hospital Albuquerque New Mexico United States 87106
97 Advantage Clinical Trials Bronx New York United States 10468
98 NY Scientific Brooklyn New York United States 11235
99 NY Scientific Brooklyn New York United States 11235
100 Adirondack Medical Research Center Glens Falls New York United States 12801
101 Northwell Health Great Neck New York United States 11021
102 Cornell University New York New York United States 10021
103 Cornell University New York New York United States 10021
104 Lenox Hill Hospital New York New York United States 10075
105 Lenox Hill Hospital New York New York United States 10075
106 Circuit Clinical Orchard Park New York United States 14127
107 Asheville Gastroenterology Associates, P.A. Asheville North Carolina United States 28801
108 Local Institution - 017 Asheville North Carolina United States 28801
109 Carolinas HealthCare System Digestive Health Charlotte North Carolina United States 28204
110 Carolinas HealthCare System Digestive Health Charlotte North Carolina United States 28204
111 Internal Medicine Research Charlotte North Carolina United States 28207
112 Internal Medicine Research Charlotte North Carolina United States 28207
113 Carolina Research Center Greenville North Carolina United States 27834
114 Carolina Research Center Greenville North Carolina United States 27834
115 Great Lakes Medical Research, LLC Beachwood Ohio United States 44122
116 Great Lakes Medical Research, LLC Beachwood Ohio United States 44122
117 Cleveland Clinic - Taussig Cancer Institute Cleveland Ohio United States 44195
118 Local Institution - 018 Cleveland Ohio United States 44195
119 Great Lakes Gastroenterology Mentor Ohio United States 44060
120 Great Lakes Gastroenterology Mentor Ohio United States 44060
121 Great Lakes Medical Research, LLC Warren Ohio United States 44483
122 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
123 University Of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
124 Digestive Disease Specialists Oklahoma City Oklahoma United States 73112
125 Digestive Disease Specialists Oklahoma City Oklahoma United States 73112
126 Oregon Health & Science University Portland Oregon United States 97239
127 Oregon Health & Science University Portland Oregon United States 97239
128 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033
129 Penn State University Milton S Hershey Medical Center State College Pennsylvania United States 16803
130 Medical University Of South Carolina Charleston South Carolina United States 29425
131 Local Institution - 121 Nashville Tennessee United States 37211
132 Quality Medical Research Nashville Tennessee United States 37211
133 Vanderbilt University Medical Center Nashville Tennessee United States 37212
134 Advanced Gastroenterology Union City Tennessee United States 38261
135 Avant Research Associates, LLC - Austin Austin Texas United States 78742
136 Avant Research Associates, LLC - Austin Austin Texas United States 78742
137 Baylor College of Medicine Houston Texas United States 77030
138 Houston Methodist Hospital Houston Texas United States 77030
139 Houston Methodist Hospital Houston Texas United States 77030
140 Texas Children's Hospital Houston Texas United States 77030
141 Biopharma Informatic Inc. Research Center Houston Texas United States 77043
142 GI Specialists of Houston Houston Texas United States 77070
143 Local Institution - 082 Houston Texas United States 77070
144 Local Institution - 088 Houston Texas United States 77084
145 Premier Vein and Vascular Center Houston Texas United States 77084
146 Sun Research Institute San Antonio Texas United States 78215
147 Sun Research Institute San Antonio Texas United States 78215
148 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
149 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
150 Digestive Health Specialists of Tyler Tyler Texas United States 75701
151 Digestive Health Specialists of Tyler Tyler Texas United States 75701
152 University of Utah School of Medicine Salt Lake City Utah United States 84132
153 University Of Utah School Of Medicine Salt Lake City Utah United States 84132
154 Gastroenterology Associates, PC Gainesville Virginia United States 20155
155 Local Institution - 189 Gainesville Virginia United States 20155
156 Local Institution - 139 Petersburg Virginia United States 23805
157 Summit Clinical Research, LLC Petersburg Virginia United States 23805
158 Virginia Gastroenterology Institute PC Suffolk Virginia United States 23434
159 University of Washington Medical Center Seattle Washington United States 98195
160 Dermatologist Specialists of Spokane Spokane Washington United States 99204
161 Dermatologist Specialists of Spokane Spokane Washington United States 99204
162 Aurora Health Care Aurora Research Grafton Wisconsin United States 53024
163 Sanatorio Guemes Ciudad Autonoma de Buenos Aires Argentina 1180
164 Hospital Privado Centro Medico de Cordoba Cordoba Argentina X5016
165 Local Institution - 495 Cordoba Argentina X5016
166 Instituto Medico de la Fundacion Estudios Clinicos Rosario Argentina 2000
167 Local Institution - 497 Rosario Argentina 2000
168 Universidad Nacional De Rosario - Hospital Provincial Del Centenario Rosario Argentina 2000
169 Local Institution - 492 San Miguel de Tucuman Argentina 4000
170 Sanatorio 9 de Julio - CICE 9 de Julio San Miguel de Tucuman Argentina 4000
171 Concord Repatriation General Hospital Concord New South Wales Australia 2139
172 Local Institution - 310 Concord New South Wales Australia 2139
173 Local Institution - 319 Kingswood New South Wales Australia 2747
174 Nepean Hospital Kingswood New South Wales Australia 2747
175 Local Institution - 323 Wollongong New South Wales Australia 2500
176 Wollongong Hospital Wollongong New South Wales Australia 2500
177 Local Institution - 311 Woolloongabba Queensland Australia 4102
178 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
179 Local Institution - 308 Adelaide South Australia Australia 5000
180 Royal Adelaide Hospital Adelaide South Australia Australia 5000
181 Local Institution - 320 Woodville South South Australia Australia 5011
182 The Queen Elizabeth Hospital Woodville South South Australia Australia 5011
183 Harry Perkins Medical Research Institute, Fiona Stanley Hospital Murdoch Western Australia Australia 6150
184 Local Institution - 316 Murdoch Western Australia Australia 6150
185 Ballarat Base Hospital Ballarat Australia 3350
186 Grodno City Clinical Hospital #4 Grodno Belarus 230026
187 Local Institution - 745 Grodno Belarus 230026
188 Local Institution - 737 Vitebsk Belarus 210604
189 Vitebsk Regional Clinical Specialized Center Vitebsk Belarus 210604
190 Algemeen Ziekenhuis Klina Brasschaat Belgium 2930
191 Local Institution - 940 Brussels Belgium 1090
192 Universitair Ziekenhuis Brussel Brussels Belgium 1090
193 University Hospital Brussels Brussels Belgium 1090
194 CHU Saint-Luc Brussels Belgium 1200
195 Queen Fabiola Children's University Hospital Brussels Belgium 1200
196 Universitair Ziehenhuis Antwerpen Edegem Belgium 2650
197 Universitair Ziekenhuis Gent Ghent Belgium 9000
198 Local Institution - 942 Leuven Belgium 3000
199 Universitair Ziekenhuis Leuven, Campus Gasthuisberg Leuven Belgium 3000
200 Clinique du Montlegia Liege Belgium 4000
201 Local Institution - 936 Liege Belgium 4000
202 Local Institution - 938 Seraing Belgium 4100
203 Sart Tilman Hospital Department of Gastroenterology and Hepatology Seraing Belgium 4100
204 Hospital Centre of Walloon Picarde Tournai Belgium 7500
205 Local Institution - 743 Banja Luka Bosnia and Herzegovina 78000
206 University Clinical Centre of the Republic of Srpska Banja Luka Bosnia and Herzegovina 78000
207 University Clinical Hospital Mostar Mostar Bosnia and Herzegovina 88000
208 Clinical Center University of Sarajevo Sarajevo Bosnia and Herzegovina 71000
209 General Hospital "Prim.dr. Abdulah Nakas" Sarajevo Bosnia and Herzegovina 71000
210 Local Institution - 738 Sarajevo Bosnia and Herzegovina 71000
211 Local Institution - 746 Plovdiv Bulgaria 4002
212 Multiprofile Hospital for Active Treatment Medline Plovdiv Bulgaria 4002
213 Local Institution - 747 Sofia Bulgaria 1202
214 Second MHAT Sofia AD Sofia Bulgaria 1202
215 Local Institution - 749 Sofia Bulgaria 1606
216 University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Sofia Bulgaria 1606
217 Local Institution - 748 Sofia Bulgaria 1784
218 University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia Sofia Bulgaria 1784
219 ACIBADEM City Clinic Medical Center Bregalnitsa Varna Bulgaria 9002
220 Local Institution - 273 Calgary Alberta Canada T2N 4Z6
221 University of Calgary Health - The Gastrointestinal Research Group (GIRG) Calgary Alberta Canada T2N 4Z6
222 Local Institution - 263 Kelowna British Columbia Canada V1Y 1Z9
223 Okanagan Clinical Trials Ltd Kelowna British Columbia Canada V1Y 1Z9
224 Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre Vancouver British Columbia Canada V5Z1M9
225 Local Institution - 261 Winnipeg Manitoba Canada R3CON2
226 Winnipeg Clinic Dermatology Research Winnipeg Manitoba Canada R3CON2
227 Local Institution - 268 Bridgewater Nova Scotia Canada B4V 3N2
228 Viable Clinical Research Bridgewater Nova Scotia Canada B4V 3N2
229 Local Institution - 252 London Ontario Canada N6A 5A5
230 London Health Sciences Centre, University Hospital London Ontario Canada N6A 5A5
231 LHSC Victoria Hospital London Ontario Canada N6A 5W9
232 Local Institution - 251 London Ontario Canada N6A 5W9
233 Local Institution - 271 Vaughan Ontario Canada L4L 4Y7
234 Toronto Digestive Disease Associates Inc Vaughan Ontario Canada L4L 4Y7
235 Local Institution - 390 Santiago Chile 8320000
236 Clinical Hospital Center Osijek Osijek Croatia 31000
237 Clinical Hospital Centre Rijeka Rijeka Croatia 51000
238 Clinical Hospital Center Split Split Croatia HR-21000
239 Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases Zagreb Croatia 10000
240 Clinical Hospital Dubrava Zagreb Croatia 10000
241 Local Institution - 766 Zagreb Croatia 10000
242 University Hospital Centre Zagreb, Clinic of Internal Diseases Zagreb Croatia 10000
243 Local Institution - 767 Brno Czechia 615 00
244 Military Hospital Brno Brno Czechia 615 00
245 Local Institution - 772 Brno Czechia 656 91
246 St. Anne's University Hospital Brno Brno Czechia 656 91
247 Hepato-Gastroenterologie HK, s. r. o. Hradec Králové Czechia 500 12
248 Local Institution - 773 Hradec Králové Czechia 500 12
249 Local Institution - 775 Most Czechia 43401
250 Soukroma Gastroenterologicka ambulance a endoskopie Most Czechia 43401
251 Local Institution - 771 Olomouc Czechia 77900
252 PreventaMed Olomouc Czechia 77900
253 Krajská nemocnice Pardubice, Kožní oddelení Pardubice Czechia 532 03
254 Local Institution - 774 Pardubice Czechia 532 03
255 Local Institution - 769 Plzen Czechia 30460
256 University Hospital Pilsen Plzen Czechia 30460
257 University Hospital Motol Prague 5 Czechia 150 06
258 ISCARE, a.s. Prague 9 Czechia 190 00
259 Local Institution - 770 Prague 9 Czechia 190 00
260 Institut klinicke a experimentalni mediciny Praha 4 Czechia 14021
261 Local Institution - 776 Praha 4 Czechia 14021
262 Bispebjerg Hospital Copenhagen Denmark 2400
263 Holbaek Hospital Holbaek Denmark 4300
264 Nykobing F Hospital Nykobing F Denmark 4800
265 Turku University Hospital Turku Finland FI-20520
266 CHU Amiens Picardie - Site Sud Amiens cedex 1 France 80054
267 Local Institution - 638 Amiens cedex 1 France 80054
268 Centre Hospitalier Intercommunal de Creteil Creteil Cedex France 94010
269 CHU de Dijon Bourgogne - Hopital Francois Mitterand Dijon Cedex France 21079
270 CHU de Grenoble Alpes Grenoble Cedex 9 France 38700
271 Local Institution - 615 Grenoble Cedex 9 France 38700
272 CHRU de Lille - Hopital Claude Huriez Lillie Cedex France 59037
273 Local Institution - 633 Lillie Cedex France 59037
274 Hopital Nord Marseille cedex 20 France 13915
275 Hospital Pontchaillou Rennes France 35033
276 Local Institution - 641 Rennes France 35033
277 CHU de Rouen Hopital Charles Nicolle Rouen Cedex France 76031
278 CHU de Toulouse Hopital Rangueil Toulouse Cedex 09 France 31059
279 Local Institution - 643 Toulouse Cedex 09 France 31059
280 Charite - Universitaetsmedizin Berlin Berlin Germany 10117
281 Local Institution - 626 Berlin Germany 10117
282 Gastroenterology Am Bayerischen Platz Berlin Germany 10825
283 DRK Clinics Berlin Berlin Germany 14050
284 Local Institution - 650 Berlin Germany 14050
285 Agaplesion Markus Krankenhaus Frankfurt Germany 60431
286 Local Institution - 662 Frankfurt Germany 60431
287 Interdisciplinary Crohn Colitis Center Rhein Main Frankfurt Germany 60594
288 Local Institution - 654 Frankfurt Germany 60594
289 Local Institution - 659 Hamburg Germany 20246
290 University Hospital Hamburg-Eppendorf Hamburg Germany 20246
291 Local Institution - 651 Leipzig Germany 04103
292 Universitaetsklinikum Leipzig AoeR Leipzig Germany 04103
293 Local Institution - 655 Ludwigshafen am Rhein Germany 67067
294 Practice for Gastroenterology and Internal Medicine Ludwigshafen am Rhein Germany 67067
295 St Marien und St Annastiftskrankenhaus Ludwigshafen am Rhein Germany 67067
296 Synesis Research Center Munich Germany 80331
297 Local Institution - 666 Tuebingen Germany 72076
298 Universitaetsklinikum Tuebingen Tuebingen Germany 72076
299 Local Institution - 663 Ulm Germany 89081
300 Universitaetsklinikum Ulm Ulm Germany 89081
301 Local Institution - 975 Dublin 4 Dublin Ireland DO4 T6F4
302 St Vincent's University Hospital Dublin 4 Dublin Ireland DO4 T6F4
303 Beaumont Hospital Dublin 9 Ireland D09 V2N0
304 Local Institution - 973 Dublin 9 Ireland D09 V2N0
305 Bat Yamon Medical Center, Clalit Medical Services Bat Yam Israel 5962025
306 Local Institution - 339 Jerusalem Israel 91031
307 Shaare Zedek Medical Center Jerusalem Israel 91031
308 Galilee Medical Center Nahariya Israel 22100
309 Local Institution - 344 Nahariya Israel 22100
310 Chaim Sheba Medical Center Ramat Gan Israel 52621
311 Local Institution - 342 Ramat Gan Israel 52621
312 Kaplan Medical Center Rechovot Israel 76100
313 Local Institution - 338 Rechovot Israel 76100
314 University Polyclinic Hospital of Bari Bari Italy 70124
315 Local Institution - 677 Bologna Italy 40138
316 Polyclinic S. Orsola-Malpighi Bologna Italy 40138
317 Civil Hospital of Brescia Brescia Italy 25123
318 Local Institution - 684 Brescia Italy 25123
319 Poliambulanza Hospital Brescia Italy 25124
320 IRCCS "Savario De Bellis" Castellana Grotte Italy 70013
321 Local Institution - 689 Castellana Grotte Italy 70013
322 Local Institution - 679 Catanzaro Italy 88100
323 University Hospital Mater Domini Catanzaro Italy 88100
324 "Ss. Annunziata" Policlinic of Chieti Chieti Italy 66100
325 Local Institution - 674 Messina Italy 98125
326 University Polyclinic Hospital G. Martino Messina Italy 98125
327 Maggiore Polyclinic Hospital, IRCCS Ca' Granda Milano Italy 20122
328 Humanitas Research Hospital - Humanitas Mirasole S.p.A Milan Italy 20089
329 Local Institution - 672 Milan Italy 20089
330 Azienda Socio Sanitaria Territoriale (ASST) di Monza Monza Italy 20900
331 Local Institution - 678 Monza Italy 20900
332 Hospital of Di Padova Padova Italy 35128
333 Local Institution - 685 Padova Italy 35128
334 United Hospitals Villa Sofia Cervello Palermo Italy 90146
335 Polyclinic San Matteo IRCCS Pavia Italy 27100
336 Polyclinic Tor Vergata Roma Italy 00133
337 Local Institution - 675 Roma Italy 00168
338 Univerisity Polyclinic Foundation Agostino Gemelli Roma Italy 00168
339 Azienda Ospedaliera San Camillo Forlanini Rome Italy 00152
340 Local Institution - 671 Rome Italy 00152
341 Integrated University Hospital Santa Maria della Misericordia of Udine Udine Italy 33100
342 Local Institution - 680 Udine Italy 33100
343 A.O. Universitaria Fondazione Macchi Varese Italy 21100
344 Local Institution - 676 Verona Italy 37024
345 Sacred Heart Don Calabria Verona Italy 37024
346 Korea University Medical Center - Korea University Ansan Hospital Ansan Korea, Republic of 152-703
347 Local Institution - 441 Busan Korea, Republic of 49201
348 Hanyang University Guri Hospital Guri-si Korea, Republic of 11923
349 Local Institution - 436 Seongnam-si Korea, Republic of 13620
350 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
351 Local Institution - 440 Seoul Korea, Republic of 06591
352 Local Institution - 430 Seoul Korea, Republic of 120-752
353 Severance Hospital Seoul Korea, Republic of 120-752
354 Local Institution - 433 Seoul Korea, Republic of 135-710
355 Samsung Medical Center Seoul Korea, Republic of 135-710
356 Local Institution - 442 Seoul Korea, Republic of 138-736
357 Kangbuk Samsung Hospital Seoul Korea, Republic of 3181
358 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 7985
359 Local Institution - 439 Seoul Korea, Republic of 7985
360 Local Institution - 602 Riga Latvia LV-1002
361 P. Stradins Clinical University Hospital Riga Latvia LV-1002
362 Digestive Diseases Center Gastro Riga Latvia LV-1006
363 Local Institution - 601 Riga Latvia LV-1006
364 Riga East Clinical University Hospital clinic Gailezers Riga Latvia LV-1038
365 Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. Zapapan Jalisco Mexico 45030
366 Local Institution - 526 Zapapan Jalisco Mexico 45030
367 Centro Regiomontano de Estudios Clinicos Roma SC. Monterrey Nuevo León Mexico 64610
368 Local Institution - 532 Monterrey Nuevo León Mexico 64610
369 Instituto Tecnológico y de Estudios Superiores de Monterrey Monterrey Nuevo León Mexico 64718
370 Local Institution - 525 Monterrey Nuevo León Mexico 64718
371 Local Institution - 529 Santiago de Queretaro Querétaro Mexico 76070
372 SMIQ Santiago de Queretaro Querétaro Mexico 76070
373 Hospital Christus Muquerza del Parque S.A. de C.V. Chihuahua Mexico 31020
374 Local Institution - 528 Chihuahua Mexico 31020
375 Centro de Investigacion Clinica Acelerada (CICA) S.C. Mexico Mexico 07020
376 Local Institution - 527 Mexico Mexico 07020
377 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Tlalpan Mexico 14080
378 Local Institution - 530 Tlalpan Mexico 14080
379 "Sfanta Treime" Clinical Municipal Hospital Chisinau Moldova, Republic of MD-2068
380 Local Institution - 811 Chisinau Moldova, Republic of MD-2068
381 Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery Chisinau Moldova, Republic of MD2005
382 "Sf. Arhanghel Mihail" Municipal Clinical Hospital Chisinau Moldova, Republic of MD2025
383 Local Institution - 809 Chisinau Moldova, Republic of MD2025
384 Local Institution - 812 Chisinau Moldova, Republic of MD2025
385 Local Institution - 813 Chisinau Moldova, Republic of MD2025
386 Republican Clinical Hospital, Department of Colorectal Surgery Chisinau Moldova, Republic of MD2025
387 Republican Clinical Hospital Chisinau Moldova, Republic of MD2025
388 Akershus University Hospital Lørenskog Norway 1478
389 Lovisenberg Diakonale Sykehus Oslo Norway 0440
390 Local Institution - 820 Bialystok Poland 15-276
391 SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego Bialystok Poland 15-276
392 Local Institution - 818 Bochnia Poland 32-700
393 Medical Services Center MaxMed Bochnia Poland 32-700
394 Nzoz All-Medicus Katowice Poland 40-660
395 Kornel Gibinski Independent Public Central Clinical Hospital in Katowice Katowice Poland 40-752
396 Local Institution - 819 Katowice Poland 40-752
397 GLOBE Clinical Research Sp. z o.o. LLC Klodzko Poland 57-300
398 Local Institution - 817 Klodzko Poland 57-300
399 Local Institution - 815 Krakow Poland 30-363
400 PLEJADY Sp. z o.o. (LLC) Medical Centre Krakow Poland 30-363
401 Landa Specialist Doctor's Offices Krakow Poland 31-156
402 Local Institution - 823 Krakow Poland 31-156
403 Krakow Medical Center LLC Krakow Poland 31-501
404 Local Institution - 826 Krakow Poland 31-501
405 Local Institution - 829 Lodz Poland 90-302
406 Santa Familia Centrum Badan, Profilaktyki i Leczenia Lodz Poland 90-302
407 Local Institution - 888 Lodz Poland 91-839
408 Salve Limited Liability Company Limited Partnership, Outpatient Clinic Lodz Poland 91-839
409 1 Military Clinical Hospital in Lublin Lublin Poland 20-049
410 Local Institution - 760 Lublin Poland 20-049
411 Local Institution - 830 Olsztyn Poland 10-561
412 Provincial Specialist Hospital in Olsztyn Olsztyn Poland 10-561
413 SOLUMED Medical Center Poznan Poland 60-529
414 Local Institution - 575 Poznan Poland 60-702
415 GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe Torun Poland 87-100
416 Local Institution - 822 Torun Poland 87-100
417 H-T. Medical Center Sp. z o.o. LLC Limited Partnership Tychy Poland 43-100
418 Local Institution - 824 Tychy Poland 43-100
419 Local Institution - 827 Ul. Piotrkowska 177 Poland 90-447
420 Polimedica Ul. Piotrkowska 177 Poland 90-447
421 Local Institution - 410 Warsaw Poland 00-632
422 Maternal Pediatric and Adolescent Healthcare Centre Warsaw Poland 00-632
423 Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Warszawa Poland 03-580
424 Hyperclinica MedLife Grivita Bucharest Romania 010719
425 Local Institution - 808 Bucharest Romania 010719
426 Local Institution - 836 Bucharest Romania 010719
427 Center of Diagnosis and Treatment Provita Bucharest Romania 021494
428 Local Institution - 795 Bucharest Romania 021494
429 Fundeni Clinical Institute Bucharest Romania 022328
430 Local Institution - 837 Bucharest Romania 022328
431 Bucharest University Emergency Hospital, Department of Internal Medicine II Bucharest Romania 050098
432 Local Institution - 839 Bucharest Romania 050098
433 Dr. Carol Davila Central Military Emergency Clinical Hospital Bucharest Romania 10825
434 Local Institution - 842 Bucharest Romania 10825
435 Craiova County Emergency Clinical Hospital Craiova Romania 200642
436 Local Institution - 843 Craiova Romania 200642
437 Colentina Clinical Hospital Napoca Romania 400001
438 Local Institution - 838 Napoca Romania 400001
439 Local Institution - 840 Targu Mures Romania 540136
440 Targu Mures County Emergency Clinical Hospital Targu Mures Romania 540136
441 Chita State Medical Academy Chita Russian Federation 672090
442 Local Institution - 598 Chita Russian Federation 672090
443 Irkutsk State Medical Academy of Postgraduate Education Irkutsk Russian Federation 664049
444 Local Institution - 848 Irkutsk Russian Federation 664049
445 City Clinical Hospital No 7 - Kazan Kazan Russian Federation 420103
446 Local Institution - 892 Kazan Russian Federation 420103
447 Regional Clinical Hospital Khanty-mansiysk Russian Federation 628012
448 Federal Siberian Research and Clinical Center Krasnoyarsk Russian Federation 660037
449 Local Institution - 927 Krasnoyarsk Russian Federation 660037
450 Moscow Clinical Scientific and Practical Center Moscow Russian Federation 111123
451 Local Institution - 594 Novosibirsk Russian Federation 630007
452 Novosibirskiy Gastrocenter Novosibirsk Russian Federation 630007
453 Local Institution - 858 Petrozavodsk Russian Federation 185019
454 Republican Hospital na VA Baranov Petrozavodsk Russian Federation 185019
455 Evromedservis Pushkin Russian Federation 196603
456 Local Institution - 859 Pushkin Russian Federation 196603
457 Clinic UZI 4D, LLC Pyatigorsk Russian Federation 357502
458 Local Institution - 960 Pyatigorsk Russian Federation 357502
459 Local Institution - 846 Pyatigorsk Russian Federation 357538
460 Pyatigorsk City Hospital 2 Pyatigorsk Russian Federation 357538
461 Local Institution - 883 Rostov-on-Don Russian Federation 344022
462 Rostov State Medical University Rostov-on-Don Russian Federation 344022
463 Medical Center Reavita Med Spb LLC Saint Petersburg Russian Federation 194354
464 Local Institution - 844 Samara Russian Federation 443041
465 Samara Station Railway Clinical Hospital under OAO Russian Railways Samara Russian Federation 443041
466 Local Institution - 862 St Petersburg Russian Federation 194044
467 S.M. Kirov Military Medical Academy St Petersburg Russian Federation 194044
468 Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office St. Petersburg Russian Federation 195067
469 Local Institution - 845 St. Petersburg Russian Federation 195067
470 Local Institution - 856 St. Petersburg Russian Federation 195257
471 SPb SBIH City Hospital of Saint Martyr Elizaveta St. Petersburg Russian Federation 195257
472 Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital Surgut Russian Federation 628408
473 Local Institution - 806 Tula Russian Federation 300053
474 Tula Regional Clinical Hospital Tula Russian Federation 300053
475 City Clinical Hospital #21 Ufa Russian Federation 450071
476 Local Institution - 861 Ufa Russian Federation 450071
477 Ulyanovsk Regional Clinical Hospital Ulyanovsk Russian Federation 432017
478 Local Institution - 855 Veliky Novgorod Russian Federation 173008
479 Novgorod Regional Clinical Hospital Veliky Novgorod Russian Federation 173008
480 Local Institution - 935 Vladimir Russian Federation 600023
481 Regional Clinical Hospital Vladimir Russian Federation 600023
482 Local Institution - 999 Vladivostok Russian Federation 690091
483 Primorsky Regional Clinical Hospital No.1 Vladivostok Russian Federation 690091
484 Local Institution - 986 Vladivostok Russian Federation 690922
485 Medical Center of Far-Eastern Federal University Vladivostok Russian Federation 690922
486 King Fahad Specialist Hospital Dammam Saudi Arabia 32253
487 King Abdul Aziz University Hospital Jeddah Saudi Arabia 22252
488 Local Institution - 537 Jeddah Saudi Arabia 22252
489 King Saud Medical Complex Riyadh Saudi Arabia 12746
490 Local Institution - 536 Riyadh Saudi Arabia 12746
491 King Fahad National Guard Hospital Riyadh Saudi Arabia 14611
492 Local Institution - 535 Riyadh Saudi Arabia 14611
493 General University Hospital of Alicante Alicante Spain 03010
494 Local Institution - 703 Alicante Spain 03010
495 Local Institution - 690 Badalona Spain 08916
496 University Hospital Germans Trias i Pujol Badalona Spain 08916
497 University Hospital of the Canary Islands (HUC) La Laguna La Laguna Spain 38320
498 Local Institution - 691 Madrid Spain 28006
499 University Hospital de La Princesa Madrid Spain 28006
500 Local Institution - 692 Madrid Spain 28046
501 University Hospital La Paz Madrid Spain 28046
502 University Hospital Virgen Macarena Sevilla Spain 41009
503 University Hospital Virgen del Rocio Sevilla Spain 41013
504 Local Institution - 700 Viladecans Spain 08840
505 Viladecans Hospital Viladecans Spain 08840
506 Lindenhofspital Bern Switzerland 3001
507 Local Institution - 967 Bern Switzerland 3001
508 Cantonal Hospital Saint Gallen St.Gallen Switzerland 9007
509 University Hospital Zurich Zurich Switzerland 8091
510 Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi Kozlu Taiwan 67000
511 Local Institution - 363 Kozlu Taiwan 67000
512 Ankara University Medical Faculty Cebeci Hospital Ankara Turkey 06590
513 Uludag Universitesi Tip Fakultesi Bursa Turkey 16059
514 Bezmialem Foundation University Medical Faculty Istanbul Turkey 34093
515 Local Institution - 362 Istanbul Turkey 34093
516 Marmara University Istanbul Turkey 34840
517 Local Institution - 354 Izmit/Kocaeli Turkey 41380
518 Goztepe Prof. Dr. Suleyman Yalcin City Hospital Kadiköy/Istanbul Turkey 41380
519 Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi Trabzon Turkey 61080
520 Local Institution - 359 Trabzon Turkey 61080
521 Chernivtsi Regional Clinical Hospital Chernivtsi Ukraine 58001
522 Local Institution - 914 Chernivtsi Ukraine 58001
523 Local Institution - 950 Dnipropetrovsk Ukraine 49074
524 Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases Dnipropetrovsk Ukraine 49074
525 Ivano-Frankivsk Central City Clinical Hospital Ivano-Frankivsk Ukraine 76018
526 Local Institution - 912 Ivano-Frankivsk Ukraine 76018
527 V.T. Zaitsev Institute of General and Emergency Surgery Kharkiv Ukraine 61018
528 Kyiv City Clinical Hospital #18 Kyiv Ukraine 01030
529 Local Institution - 901 Kyiv Ukraine 01030
530 Local Institution - 915 Kyiv Ukraine 02000
531 Medical Center Consilium Medical Kyiv Ukraine 02000
532 Local Institution - 911 Kyiv Ukraine 02175
533 Ok Clinic Medical Center within International Institute of Clinical Trials, LLC Kyiv Ukraine 02175
534 Kyiv Regional Hospital #2 Kyiv Ukraine 04053
535 Local Institution - 918 Kyiv Ukraine 04053
536 Kyiv Regional Clinical Hospital Kyiv Ukraine 04107
537 Local Institution - 908 Kyiv Ukraine 04107
538 Local Institution - 562 Kyiv Ukraine 4210
539 Public City Clinical Hospital of Emergency Medical Care Lviv Ukraine 79059
540 Local Institution - 905 Poltava Ukraine 36011
541 Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council Poltava Ukraine 36011
542 Local Institution - 934 Ternopil Ukraine 46008
543 Ternopil City Public Emergency Medical Care Hospital Ternopil Ukraine 46008
544 Local Institution - 909 Vinnytsia Ukraine 02029
545 Vinnytsia City Clinical Hospital #1 Vinnytsia Ukraine 02029
546 Local Institution - 971 Vinnytsia Ukraine 21018
547 Vinnytsia M.I. Pyrohov Regional Clinical Hospital Vinnytsia Ukraine 21018
548 First Private Clinic Zhytomyr Ukraine 10003
549 Local Institution - 557 Birmingham United Kingdom B15 2SQ
550 Bristol Royal Infirmary Bristol United Kingdom BS2 8HW
551 Local Institution - 712 Dundonald United Kingdom BT16 1RH
552 Ulster Hospital Dundonald United Kingdom BT16 1RH
553 Local Institution - 713 Glasgow United Kingdom G51 4TF
554 Queen Elizabeth University Hospital Glasgow United Kingdom G51 4TF
555 Victoria Hospital Blackpool Lancashire Blackpool United Kingdom FY3 8NR
556 Local Institution - 722 London United Kingdom E1 1BB
557 Royal London Hospital London United Kingdom E1 1BB
558 University College London Hospitals NHS Foundation Trust - University College Hospital London United Kingdom NW1 2BU
559 Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital London United Kingdom SE1 9RT
560 Local Institution - 715 London United Kingdom SE1 9RT
561 John Radcliffe Hospital Oxford United Kingdom OX3 9DU
562 Royal Shrewsbury Hospital Shrewsbury United Kingdom SY38XQ
563 Local Institution - 723 Southampton United Kingdom SO16 6YD
564 University Hospital Southampton NHS Foundation Trust - Southampton General Hospital Southampton United Kingdom SO16 6YD
565 Torbay Hospital Torquay United Kingdom TQ2 7AA

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:
NCT03440372
Other Study ID Numbers:
  • RPC01-3201
  • U1111-1203-7225
  • 2017-004292-31
First Posted:
Feb 22, 2018
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
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:

Study Results

No Results Posted as of Aug 24, 2022