Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease Clinical Trial Results and Information

Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov processed this data on November 11, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified November 2024 by Celgene

Sponsor

Celgene

Information Provided by (Responsible Party)

Celgene

Clinicaltrials.gov Identifier

NCT03440385
Other Study ID Numbers: RPC01-3202
First Submitted: February 14, 2018
First Posted: February 22, 2018
Results First Posted: December 5, 2024
Last Update Posted: December 5, 2024
Last Verified: November 2024
History of Changes

Disclaimer

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Crohn Disease	Drug: Ozanimod Other: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	606 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
Official Title	Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Study Start Date	March 7, 2018
Actual Primary Completion Date	November 21, 2023
Actual Study Completion Date	November 21, 2023

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Administration of oral Ozanimod	Drug: Ozanimod Specified dose on specified days
Administration of Placebo	Other: Placebo

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 [Week 12]
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

Secondary Outcome Measures

Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission [Week 12]
Abdominal pain and stool frequency clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 with abdominal pain and stool frequency no worse than baseline at Week 12. Participants entered the responses in diaries daily. The 7 days entries prior to Week 12 visit were considered for calculating average abdominal pain score and stool frequency. The abdominal pain was graded on severity of 0 (none) to 3 (severe) scale and stool frequency was defined number of liquid or soft stools per day. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% [Week 12]
The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150 [Week 12]
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50% [Week 12]
CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50% [Week 12]
CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points [Week 12]
Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
Percentage of Participants With Global Histologic Activity Score (GHAS) Remission [Week 12]
GHAS assesses the inflammation and mucosal damage. GHAS has 8 components Epithelial damage, Architectural changes, Infiltration of mononuclear cells in the lamina propria, Infiltration of polymorphonuclear cells in the lamina propria, Polymorphonuclear cells in epithelium, Presence of erosion and/or ulcers, Presence of granuloma and number of biopsy specimens affected. Each of these components was scored on a scale of 0 (none/unaffected) to 2 (worst). Each of these 8 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. Within each segment, the GHAS score has a range of 0 - 16, and the total GHAS score has a range of 0 - 80. Higher numbers correspond to more inflammation and more mucosal damage. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Percentage of Participants With CDAI Reduction From Baseline of >=70 Points [Week 12]
The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 [none] to 3 [Severe]), general well-being (0 [well] to 4 [terrible] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10% [Week 12]
The ulcerated surface were assessed via endoscopy.
Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50% [Week 12]
CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response [Week 12]
AP and SF clinical remission is average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). Endoscopic Response is defined as >= 50% decrease from baseline in SES-CD. In SES-CD, each of 4 components are assessed in five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was sum of individual scores of each of components across five segments. Range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12 [Week 12]
RHI mucosal healing was defined as RHI remission combined with SES-CD <= 4 points and a SES-CD decrease from baseline >= 2 points with no SES-CD sub-score >1 point. RHI Remission is defined as no active inflammation in any measured segment. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation.

Eligibility Criteria

Ages Eligible for Study	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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 therapy Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Exclusion Criteria	Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention 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

Sponsors and Collaborators	Celgene
Locations	Local Institution - 202 \| Scottsdale, Arizona, United States, 85258 Ucsd Medical Center \| La Jolla, California, United States, 92037 Local Institution - 010 \| Lancaster, California, United States, 93534 Southern California Research Institute Medical Group, Inc. \| Los Angeles, California, United States, 90045 Matrix Clinical Research Inc \| Los Angeles, California, United States, 90048 Facey Medical Foundation (Parent) \| Mission Hills, California, United States, 91345 Local Institution - 093 \| Pasadena, California, United States, 91105 Sutter Medical Group \| Roseville, California, United States, 95661 Local Institution - 280 \| Sacramento, California, United States, 95817 Local Institution - 281 \| San Francisco, California, United States, 94158 Local Institution - 124 \| West Covina, California, United States, 91790 Local Institution - 065 \| Colorado Springs, Colorado, United States, 80907 Local Institution - 182 \| Bristol, Connecticut, United States, 06010 Local Institution - 166 \| Clearwater, Florida, United States, 33765 Local Institution - 084 \| Clermont, Florida, United States, 34711 American Research Institute Inc \| Cutler Bay, Florida, United States, 33157 Local Institution - 112 \| Doral, Florida, United States, 33166 Riverside Clinical Research \| Edgewater, Florida, United States, 32132 SIH Research \| Kissimmee, Florida, United States, 34759 Local Institution - 067 \| Lighthouse Point, Florida, United States, 33064 Center For Advanced Gastroenterology \| Maitland, Florida, United States, 32751 Local Institution - 044 \| Miami Springs, Florida, United States, 33166 LMG Research \| Miami, Florida, United States, 33125 Local Institution - 175 \| Miami, Florida, United States, 33166 Local Institution - 081 \| Miami, Florida, United States, 33176 Local Institution - 192 \| New Port Richey, Florida, United States, 34655 Local Institution - 200 \| Orlando, Florida, United States, 32810 Local Institution - 002 \| Palmetto Bay, Florida, United States, 33157 Theia Clinical Research, LLC \| Pinellas Park, Florida, United States, 33781 Precision Clinical Research, LLC. \| Sunrise, Florida, United States, 33351 Local Institution - 183 \| Tampa, Florida, United States, 33612-4799 Apex Clinical Research \| Tampa, Florida, United States, 33612 Local Institution - 107 \| Tampa, Florida, United States, 33614 Local Institution - 037 \| Atlanta, Georgia, United States, 30322 Local Institution - 220 \| Atlanta, Georgia, United States, 30322 Local Institution - 143 \| Decatur, Georgia, United States, 30030 Local Institution - 115 \| Idaho Falls, Idaho, United States, 83404 Local Institution - 022 \| Chicago, Illinois, United States, 60637 Local Institution - 092 \| Evansville, Indiana, United States, 47714 Local Institution - 033 \| Indianapolis, Indiana, United States, 46202 Local Institution - 070 \| Topeka, Kansas, United States, 66606 Local Institution - 020 \| Baton Rouge, Louisiana, United States, 70809 Clinical Trials of SW Louisiana LLC \| Lake Charles, Louisiana, United States, 70601 Tandem Clinical Research, LLC \| Marrero, Louisiana, United States, 70072 Local Institution - 024 \| Worcester, Massachusetts, United States, 01655 Local Institution - 167 \| Kalamazoo, Michigan, United States, 49008 Local Institution - 005 \| Novi, Michigan, United States, 48377 Local Institution - 095 \| Minneapolis, Minnesota, United States, 55455 Local Institution - 045 \| Rochester, Minnesota, United States, 55905 Local Institution - 198 \| Kansas City, Missouri, United States, 64111 Internal Medicine Specialists \| Las Vegas, Nevada, United States, 89145 Local Institution - 040 \| Lebanon, New Hampshire, United States, 03756 Local Institution - 054 \| Hartsdale, New York, United States, 10530 Weill Cornell Medical College \| New York, New York, United States, 10010 Concorde Medical Group \| New York, New York, United States, 10016 TrialSpark \| New York, New York, United States, 10024 Local Institution - 060 \| North Massapequa, New York, United States, 11758-1802 Local Institution - 156 \| Charlotte, North Carolina, United States, 28209 Local Institution - 052 \| Winston-Salem, North Carolina, United States, 27103 Local Institution - 170 \| Dayton, Ohio, United States, 45417 Local Institution - 049 \| Hilliard, Ohio, United States, 43026 Paramount Medical Research & Consulting, Llc \| Middleburg Heights, Ohio, United States, 44130 Local Institution - 087 \| Norman, Oklahoma, United States, 73071 Local Institution - 294 \| Oklahoma City, Oklahoma, United States, 73102 Local Institution - 185 \| Tulsa, Oklahoma, United States, 74136 Local Institution - 217 \| Tulsa, Oklahoma, United States, 74137 University of Pennsylvania Cancer Center \| Philadelphia, Pennsylvania, United States, 19104 Local Institution - 034 \| Fort Sam Houston, Texas, United States, 78234 Local Institution - 079 \| Houston, Texas, United States, 77058 Local Institution - 196 \| Houston, Texas, United States, 77089 Gulf Coast Research Group LLC \| Houston, Texas, United States, 77098 Accurate Clinical Research Inc \| Pasadena, Texas, United States, 77505 Local Institution - 071 \| Richardson, Texas, United States, 75082 Local Institution - 178 \| San Antonio, Texas, United States, 78229 Local Institution - 181 \| Temple, Texas, United States, 76508 Local Institution - 292 \| Riverton, Utah, United States, 84065 Local Institution - 030 \| Lynchburg, Virginia, United States, 24502 The Gastroenterology Group \| Reston, Virginia, United States, 20191 Local Institution - 072 \| Richmond, Virginia, United States, 23249 Local Institution - 172 \| Roanoke, Virginia, United States, 24016 Local Institution - 089 \| La Crosse, Wisconsin, United States, 54601 Local Institution - 309 \| Liverpool, New South Wales, Australia, 2170 Local Institution - 318 \| New Lambton Heights, New South Wales, Australia, 2305 Local Institution - 328 \| Herston, Queensland, Australia, 4029 Local Institution - 313 \| Maroorchydore, Queensland, Australia, 4558 Local Institution - 321 \| North Mackay, Queensland, Australia, 4740 Local Institution - 312 \| South Brisbane, Queensland, Australia, 4101 Local Institution - 307 \| Bedford Park, South Australia, Australia, 5042 Local Institution - 326 \| Elizabeth Vale, South Australia, Australia, 05112 Local Institution - 317 \| Clayton, Victoria, Australia, 3168 Local Institution - 305 \| Fitzroy, Victoria, Australia, 3065 Local Institution - 329 \| Geelong, Victoria, Australia, 3220 Local Institution - 327 \| Melbourne, Victoria, Australia, 3004 Local Institution - 315 \| Subiaco, Western Australia, Australia, 6008 Local Institution - 726 \| Innsbruck, Austria, 6020 Local Institution - 727 \| St Polten, Austria, 3100 Local Institution - 336 \| Vienna, Austria, 1020 Local Institution - 725 \| Vienna, Austria, 1090 Local Institution - 753 \| Ruse, Bulgaria, 7002 Local Institution - 750 \| Sofia, Bulgaria, 1407 Local Institution - 755 \| Sofia, Bulgaria, 1407 Local Institution - 756 \| Sofia, Bulgaria, 1431 Local Institution - 752 \| Sofia, Bulgaria, 1527 Local Institution - 554 \| Sofia, Bulgaria, 1784 Local Institution - 269 \| Edmonton, Alberta, Canada, T5R1W2 Local Institution - 262 \| New Westminister, British Columbia, Canada, V3L 3W5 Local Institution - 267 \| Vancouver, British Columbia, Canada, V6Z 2K5 Local Institution - 256 \| Brandon, Manitoba, Canada, R7A 0N7 Local Institution - 266 \| Sudbury, Ontario, Canada, P3C 5K6 Local Institution - 264 \| Toronto, Ontario, Canada, M5G 1X5 Local Institution - 257 \| Toronto, Ontario, Canada, M5T 3A9 Local Institution - 254 \| Montreal, Quebec, Canada, H1T 2M4 Local Institution - 270 \| Ottawa, Quebec, Canada, K1H 8L6 Local Institution - 423 \| Changzhou City, Jiangsu, China, 213003 Local Institution - 369 \| Shanghai, Shanghai, China, 200120 Local Institution - 482 \| Beijing, China, 100050 Local Institution - 467 \| Beijing, China, 100700 Local Institution - 379 \| Bengbu, China, 233004 Local Institution - 485 \| Changchun, China, 130021 Local Institution - 376 \| Changchun, China, 130033 Local Institution - 421 \| Changsha, China, 410008 Local Institution - 378 \| Changsha, China, 450052 Local Institution - 414 \| Changzhou, China, 213004 Local Institution - 419 \| Chengdu, China, 610041 Local Institution - 422 \| Fuzhou, China, 350005 Local Institution - 472 \| Guangzhou Shi, China, 510180 Local Institution - 486 \| Guangzhou Shi, China, 510655 Local Institution - 478 \| Guangzhou, China, 510030 Local Institution - 470 \| Hangzhou, Zhejiang, China, 100142 Local Institution - 491 \| Hefei, China, 230001 Local Institution - 374 \| Kunming, China, 650032 Local Institution - 383 \| Luzhou, China, 646099 Local Institution - 488 \| Nanchang, China, 330006 Local Institution - 418 \| Nanjing City, China, 210008 Local Institution - 375 \| Nanjing, China, 210009 Local Institution - 487 \| Nanjing, China, 210029 Local Institution - 473 \| Shanghai, China, 200025 Local Institution - 380 \| Shanghai, China, 200040 Local Institution - 377 \| Shanghai, China, 200080 Local Institution - 458 \| Taichung City, China, 40447 Local Institution - 373 \| Tianjin, China, 300052 Local Institution - 483 \| Wuhan Shi, China, 430060 Local Institution - 475 \| Wuhan, China, 430022 Local Institution - 474 \| Wuhan, China, 430030 Local Institution - 381 \| Wuxi, China, 214023 Local Institution - 415 \| Xi'an, China, 710038 Local Institution - 420 \| Xi'an, China, 710100 Local Institution - 370 \| Zhengzhou, China, 450014 Local Institution - 397 \| Armenia, Colombia, 630004 Local Institution - 398 \| Barranquilla, Colombia, 080020 Local Institution - 395 \| Bogota, Colombia, 110221 Local Institution - 396 \| Cali, Colombia, 760026 Local Institution - 394 \| Medellin, Colombia, 050034 Local Institution - 613 \| Helsinki, Finland, 00290 Local Institution - 614 \| Turku, Finland, FI-20521 Local Institution - 647 \| Neuilly-sur-Seine, Cedex, France, 92200 Local Institution - 635 \| Blois Cedex, France, 41016 Local Institution - 639 \| Béziers, France, 34525 Local Institution - 634 \| Caen, France, 14000 Local Institution - 644 \| Colombes, France, 92701 Local Institution - 632 \| Nantes, France, 44093 Local Institution - 630 \| Pierre-Benite, France, 69495 Local Institution - 631 \| Saint Priest en Jarez, France, 42270 Local Institution - 786 \| Batumi, Georgia, 6010 Local Institution - 779 \| Kutaisi, Georgia, 4600 Local Institution - 454 \| Tbilisi, Georgia, 0101 Local Institution - 778 \| Tbilisi, Georgia, 0112 Local Institution - 782 \| Tbilisi, Georgia, 0131 Local Institution - 552 \| Tbilisi, Georgia, 0144 Local Institution - 793 \| Tbilisi, Georgia, 0159 Local Institution - 740 \| Tbilisi, Georgia, 0160 Local Institution - 783 \| Tbilisi, Georgia, 0160 Local Institution - 784 \| Tbilisi, Georgia, 0160 Local Institution - 785 \| Tbilisi, Georgia, 0160 Local Institution - 335 \| Tbilisi, Georgia, 0179 Local Institution - 455 \| Tbilisi, Georgia, 0180 Local Institution - 781 \| Tbilisi, Georgia, 0186 Local Institution - 780 \| Telavi, Georgia, 2200 Local Institution - 629 \| Berlin, Germany, 10787 Local Institution - 653 \| Berlin, Germany, 12200 Local Institution - 648 \| Berlin, Germany, 13353 Local Institution - 628 \| Berlin, Germany, 14163 Local Institution - 664 \| Brandenburg an der Havel, Germany, 14770 Local Institution - 732 \| Dachau, Germany, 85221 Local Institution - 574 \| Frankfurt am Main, Germany, 60313 Local Institution - 657 \| Frankfurt am Main, Germany, 60590 Local Institution - 658 \| Halle, Germany, 06108 Local Institution - 656 \| Halle, Germany, 06120 Local Institution - 652 \| Hamburg, Germany, 22559 Local Institution - 591 \| Hannover, Germany, 30625 Local Institution - 649 \| Keil, Germany, 24105 Local Institution - 337 \| Leipzig, Germany, 04103 Local Institution - 660 \| Mainz, Germany, 55131 Local Institution - 667 \| Muenster, Germany, 48149 Local Institution - 620 \| Neuruppin, Germany, 16816 Local Institution - 584 \| Nuertingen, Germany, 72622 Local Institution - 661 \| Stuttgart, Germany, 70376 Local Institution - 592 \| Athens, Attiki, Greece, 15562 Local Institution - 790 \| Athens, Greece, 11 527 Local Institution - 588 \| Athens, Greece, 115 28 Local Institution - 791 \| Athens, Greece, 11527 Local Institution - 792 \| Athens, Greece, 18536 Local Institution - 787 \| Heraklion, Greece, 71 110 Local Institution - 789 \| Thessaloniki, Greece, 54642 Local Institution - 788 \| Thessaloniki, Greece, 56429 Local Institution - 404 \| Hong Kong, Hong Kong, Array Local Institution - 405 \| Kowloon, Hong Kong, Array Local Institution - 798 \| Bekescsaba, Hungary, 5600 Local Institution - 803 \| Budapest, Hungary, 1062 Local Institution - 804 \| Budapest, Hungary, 1088 Local Institution - 556 \| Budapest, Hungary, H-1036 Local Institution - 801 \| Gyor, Hungary, 9024 Local Institution - 555 \| Gyula, Hungary, 5700 Local Institution - 797 \| Miskolc, Hungary, 3529 Local Institution - 800 \| Nagykanizsa, Hungary, H-8800 Local Institution - 799 \| Szekesfehervar, Hungary, 8000 Local Institution - 816 \| Szekszárd, Hungary, 7100 Local Institution - 805 \| Szentes, Hungary, 6600 Local Institution - 343 \| Afula, Israel, 18341 Local Institution - 346 \| Beer Jacob, Israel, 73100 Local Institution - 350 \| Haifa, Israel, 3109601 Local Institution - 347 \| Jerusalem, Israel, 9362410 Local Institution - 349 \| Kfar-Saba, Israel, 44281 Local Institution - 341 \| Petah Tikva, Israel, 49100 Local Institution - 340 \| Tel-Aviv, Israel, 64239 Local Institution - 434 \| Busan, Korea, Republic of, 49241 Local Institution - 431 \| Busan, Korea, Republic of, 612-030 Local Institution - 432 \| Daegu, Korea, Republic of, 705-030 Local Institution - 438 \| Seoul, Korea, Republic of, 3080 Local Institution - 429 \| Suwon, Korea, Republic of, 442723 Local Institution - 605 \| Kaunas, Lithuania, LT-50009 Local Institution - 603 \| Klaipeda, Lithuania, LT-5808 Local Institution - 607 \| Vilnius, Lithuania, 08406 Local Institution - 606 \| Vilnius, Lithuania, LT-08661 Local Institution - 604 \| Vilnius, Lithuania, LT-10207 Local Institution - 952 \| Amsterdam, Netherlands, 1081 HV Local Institution - 955 \| Amsterdam, Netherlands, 1105 AZ Local Institution - 956 \| Groningen, Netherlands, 9713 GZ Local Institution - 949 \| Nijmegen, Netherlands, 6525 GA Local Institution - 951 \| Sittard-Geleen, Netherlands, 6162 BG Local Institution - 954 \| Tilburg, Netherlands, 5022 GC Local Institution - 580 \| Czestochowa, Poland, 42-202 Local Institution - 988 \| Elblag, Poland, 82-300 Local Institution - 579 \| Gdansk, Poland, 80-382 Local Institution - 978 \| Gdansk, Poland, 80-803 Local Institution - 577 \| Gdynia, Poland, 81-537 Local Institution - 906 \| Jelenia Gora, Poland, 58-500 Local Institution - 757 \| Jozefow, Poland, 05-410 Local Institution - 578 \| Katowice, Poland, 40-040 Local Institution - 834 \| Ksawerow, Poland, 95-054 Local Institution - 581 \| Lodz, Poland, 90-127 Local Institution - 981 \| Lodz, Poland, 93-034 Local Institution - 976 \| Nowy Targ, Poland, 34-400 Local Institution - 963 \| Rzeszow, Poland, 35-302 Local Institution - 979 \| Sopot, Poland, 81-756 Local Institution - 835 \| Szczecin, Poland, 71-270 Local Institution - 586 \| Warsaw, Poland, 00-728 Local Institution - 833 \| Warsaw, Poland, 02-018 Local Institution - 807 \| Warsaw, Poland, 04-730 Local Institution - 989 \| Warszawa, Poland, 02-653 Local Institution - 893 \| Wierzchoslawice, Poland, 33-122 Local Institution - 983 \| Wroclaw, Poland, 50-053 Local Institution - 984 \| Wroclaw, Poland, 50-367 Local Institution - 582 \| Wroclaw, Poland, 50-381 Local Institution - 982 \| Wroclaw, Poland, 51-162 Local Institution - 831 \| Wroclaw, Poland, 53-114 Local Institution - 987 \| Wroclaw, Poland, 53-333 Local Institution - 832 \| Wroclaw, Poland, 54-144 Local Institution - 959 \| Coimbra, Portugal, 3000-075 Local Institution - 958 \| Guimaraes, Portugal, 4835-044 Local Institution - 961 \| Loures, Portugal, 2674-514 Local Institution - 957 \| Viana do Castelo, Portugal, 4904-858 Local Institution - 966 \| Barnaul, Russian Federation, 656015 Local Institution - 871 \| Barnaul, Russian Federation, 656024 Local Institution - 589 \| Bataisk, Russian Federation, 346880 Local Institution - 621 \| Chelyabinsk, Russian Federation, 454021 Local Institution - 991 \| Chelyabinsk, Russian Federation, 454076 Local Institution - 583 \| Ekaterinburg, Russian Federation, 620075 Local Institution - 872 \| Ekaterinburg, Russian Federation, 620109 Local Institution - 998 \| Kaliningrad, Russian Federation, 236016 Local Institution - 882 \| Kaluga, Russian Federation, 248007 Local Institution - 849 \| Kemerovo, Russian Federation, 650066 Local Institution - 566 \| Moscow, Russian Federation, 105554 Local Institution - 995 \| Moscow, Russian Federation, 115516 Local Institution - 873 \| Moscow, Russian Federation, 117997 Local Institution - 870 \| Moscow, Russian Federation, 119192 Local Institution - 869 \| Moscow, Russian Federation, 123423 Local Institution - 990 \| Nizhny Novgorod, Russian Federation, 603140 Local Institution - 853 \| Novosibirsk, Russian Federation, 630091 Local Institution - 876 \| Novosibirsk, Russian Federation, 630117 Local Institution - 996 \| Omsk, Russian Federation, 644024 Local Institution - 875 \| Orenburg, Russian Federation, 460050 Local Institution - 867 \| Penza, Russian Federation, 440026 Local Institution - 874 \| Saint Petersburg, Russian Federation, 197110 Local Institution - 868 \| Saint-Petersburg, Russian Federation, 194044 Local Institution - 865 \| Samara, Russian Federation, 443001 Local Institution - 992 \| Saratov, Russian Federation, 410053 Local Institution - 866 \| Sochi, Russian Federation, 354207 Local Institution - 878 \| St Petersburg, Russian Federation, 196247 Local Institution - 863 \| St. Petersburg, Russian Federation, 191015 Local Institution - 993 \| St. Petersburg, Russian Federation, 191015 Local Institution - 857 \| St. Petersburg, Russian Federation, 195009 Local Institution - 879 \| St. Petersburg, Russian Federation, 196143 Local Institution - 877 \| Tomsk, Russian Federation, 634063 Local Institution - 881 \| Ufa, Russian Federation, 450005 Local Institution - 880 \| Volgograd, Russian Federation, 400107 Local Institution - 546 \| Cape Town, Senegal, 7500 Local Institution - 887 \| Belgrade, Serbia, 11 080 Local Institution - 596 \| Belgrade, Serbia, 11000 Local Institution - 886 \| Belgrade, Serbia, 11000 Local Institution - 890 \| Belgrade, Serbia, 11000 Local Institution - 891 \| Kragujevac, Serbia, 34000 Local Institution - 884 \| Novi Sad, Serbia, 21 000 Local Institution - 885 \| Pancevo, Serbia, 26000 Local Institution - 585 \| Vrsac, Serbia, 26300 Local Institution - 889 \| Zrenjanin, Serbia, 23 000 Local Institution - 900 \| Bratislava, Slovakia, 820 07 Local Institution - 894 \| Bratislava, Slovakia, 82606 Local Institution - 895 \| Brezno, Slovakia, 97701 Local Institution - 899 \| Nitra, Slovakia, 94901 Local Institution - 897 \| Nove Zamky, Slovakia, 94002 Local Institution - 898 \| Presov, Slovakia, 080 01 Local Institution - 896 \| Rimavska Sobota, Slovakia, 979 01 Local Institution - 904 \| Celje, Slovenia, 3000 Local Institution - 543 \| Gauteng, South Africa, 1820 Local Institution - 545 \| Kempton Park, South Africa, 1619 Local Institution - 544 \| Pretoria, South Africa, 0001 Local Institution - 542 \| Pretoria, South Africa, 0084 Local Institution - 549 \| Pretoria, South Africa, 0181 Local Institution - 548 \| Somerset West, South Africa, 7130 Local Institution - 547 \| Val De Grace, South Africa, 0184 Teknon Medical Center \| Barcelona, Spain, 08022 University Hospital Reina Sofia \| Cordoba, Spain, 14001 University Hospital of Girona Dr. Josep Trueta \| Girona, Spain, 17007 Hospital Universitario De Gran Canaria Dr. Negrin \| Las Palmas de Gran Canaria, Spain, 35012 Local Institution - 695 \| Madrid, Spain, 28040 University Hospital Puerta de Hierro Majadajonda \| Majadahonda, Madrid, Spain, 28222 University Hospital Marques de Valdecilla (HUMV) \| Santander, Spain, 39008 Local Institution - 697 \| Valencia, Spain, 46010 Local Institution - 625 \| Stockholm, Sweden, 112 81 Local Institution - 463 \| Kaohsiung, San Ming Dist., Taiwan, 807 Local Institution - 460 \| Kaohsiung, Taiwan, 82445 Local Institution - 461 \| Niao-Sung Hsiang Kaohsiung County, Taiwan, 83301 Local Institution - 459 \| Tainan, Taiana, Taiwan, 704 Local Institution - 462 \| Taoyuan City, Taiwan, 33305 Local Institution - 464 \| Tapei, Beitou Dist., Taiwan, 11217 Local Institution - 465 \| Tapei, Taiwan, 10002 Local Institution - 357 \| Ankara, Turkey, 01660 Local Institution - 365 \| Elazig, Turkey, 23119 Local Institution - 358 \| Istanbul, Turkey, 34098 Local Institution - 361 \| Istanbul, Turkey, 34668 Local Institution - 353 \| Kadiköy/Istanbul, Turkey, 41380 Local Institution - 922 \| Chernivtsi, Ukraine, 58001 Local Institution - 929 \| Ivano-Frankivsk, Ukraine, 76008 Local Institution - 965 \| Kharkiv, Ukraine, 61037 Local Institution - 920 \| Khmelnytskyi, Ukraine, 29000 Local Institution - 933 \| Kropyvnytskyi, Ukraine, 25006 Local Institution - 923 \| Kyiv, Ukraine, 01601 Local Institution - 563 \| Kyiv, Ukraine, 02002 Local Institution - 564 \| Kyiv, Ukraine, 03037 Local Institution - 977 \| Kyiv, Ukraine, 04107 Local Institution - 590 \| Lutsk, Ukraine, 43005 Local Institution - 974 \| Lviv, Ukraine, 79010 Local Institution - 902 \| Odesa, Ukraine, 65025 Local Institution - 924 \| Vinnytsia, Ukraine, 21018 Local Institution - 932 \| Vinnytsya, Ukraine, 21009 Local Institution - 587 \| Zaporizhia, Ukraine, 69063 Local Institution - 925 \| Zaporizhzhya, Ukraine, 69600
Investigators

Study Documents (Full Text)

Documents Provided by Celgene: Study Protocol and Statistical Analysis Plan June 14, 2021

More Information

Additional Information

Publications

Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

Additional Relevant MeSH Terms

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases