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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1203-8002 | Registry Identifier | WHO | |
| 2023-510426-33 | Registry Identifier | EU Trial Number |
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The study has terminated due to non-safety reasons; Business Objectives have changed.
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This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozanimod | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Specified dose on specified days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed | 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. | Week 52 |
| Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores | 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed | 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. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Center for Family Health | Peoria | Arizona | 85381 | United States | ||
| Local Institution - 202 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36208720 | Derived | 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. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Participants who completed initial 12 weeks of treatment in induction studies RPC01-3201 (NCT03440372) or RPC01-3202 (NCT03440385) and are in clinical response (CDAI [Crohn's Disease Activity Index] reduction from baseline ≥100 points or CDAI score<150),clinical remission (CDAI score < 150),and/or have an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤1with abdominal pain and stool frequency no worse than baseline were eligible to participate.
This study was a maintenance study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozanimod 0.92 mg / Ozanimod 0.92 mg | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2024 |
Not provided
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| Other |
Specified dose on specified days |
|
| Week 52 |
| Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52 | 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. | Week 52 |
| Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1 | 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. | Week 52 |
| Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1 | 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. | Week 52 |
| Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases | The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Week 52 |
| Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Week 52 |
| Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52 | 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. | Week 52 |
| Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52 | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Week 52 |
| Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. | Week 52 |
| Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1 | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. | Week 52 |
| Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52 | 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. | Week 52 |
| Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Week 52 |
| Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52 | 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. | Week 52 |
| Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1 | 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. | Week 52 |
| Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52 | 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Week 52 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Local Institution - 026 | North Little Rock | Arkansas | 72117 | United States |
| Local Institution - 284 | Camarillo | California | 93012 | United States |
| Sharp Chula Vista Medical Center | Chula Vista | California | 91911 | United States |
| Local Institution - 039 | Garden Grove | California | 92843 | United States |
| Ucsd Medical Center | La Jolla | California | 92037 | United States |
| San Diego Clinical Trials | La Mesa | California | 91942 | United States |
| Local Institution - 010 | Lancaster | California | 93534 | United States |
| Local Institution - 061 | Los Angeles | California | 90027 | United States |
| Southern California Research Institute Medical Group, Inc. | Los Angeles | California | 90045 | United States |
| Matrix Clinical Research Inc | Los Angeles | California | 90048 | United States |
| Local Institution - 110 | Los Angeles | California | 90067 | United States |
| Facey Medical Foundation (Parent) | Mission Hills | California | 91345 | United States |
| ABS Health, LLC | Mission Viejo | California | 92691 | United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Local Institution - 027 | Orange | California | 92868 | United States |
| Palo Alto Center-Palo Alto Medical Foundation Research Institute | Palo Alto | California | 94304 | United States |
| Havana Research Institute LLC | Pasadena | California | 91105 | United States |
| Local Institution - 006 | Rialto | California | 92377 | United States |
| Sutter Medical Group | Roseville | California | 95661 | United States |
| Local Institution - 280 | Sacramento | California | 95817 | United States |
| Local Institution - 003 | San Diego | California | 92123 | United States |
| Local Institution - 281 | San Francisco | California | 94158 | United States |
| New Hope Research Development | West Covina | California | 91790 | United States |
| Local Institution - 065 | Colorado Springs | Colorado | 80907 | United States |
| Local Institution - 297 | Lakewood | Colorado | 80228 | United States |
| Local Institution - 182 | Bristol | Connecticut | 06010 | United States |
| Local Institution - 225 | Bristol | Connecticut | 06010 | United States |
| Local Institution - 091 | New Haven | Connecticut | 06510 | United States |
| Local Institution - 062 | Clearwater | Florida | 33756-3839 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| South Lake Pain Institute | Clermont | Florida | 34711 | United States |
| American Research Institute Inc | Cutler Bay | Florida | 33157 | United States |
| Universal Axon Clinical Research | Doral | Florida | 33166 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Local Institution - 218 | Gainesville | Florida | 32608 | United States |
| Local Institution - 203 | Hialeah | Florida | 33010 | United States |
| Floridian Clinical Research LLC | Hialeah | Florida | 33016 | United States |
| Harmony Medical Research Institute | Hialeah | Florida | 33016 | United States |
| Local Institution - 179 | Hollywood | Florida | 33021 | United States |
| Vista Health Research | Homestead | Florida | 33033 | United States |
| SIH Research | Kissimmee | Florida | 34759 | United States |
| Local Institution - 016 | Largo | Florida | 33777 | United States |
| Local Institution - 067 | Lighthouse PT | Florida | 33064 | United States |
| Center For Advanced Gastroenterology | Maitland | Florida | 32751 | United States |
| LMG Research | Miami | Florida | 33125 | United States |
| Local Institution - 199 | Miami | Florida | 33125 | United States |
| LCC Medical Research Institute, LLC | Miami | Florida | 33126 | United States |
| Local Institution - 169 | Miami | Florida | 33156 | United States |
| Local Institution - 175 | Miami | Florida | 33166 | United States |
| Vista Health Research | Miami | Florida | 33176 | United States |
| Local Institution - 044 | Miami Springs | Florida | 33166 | United States |
| Advanced Research for Health Improvement | Naples | Florida | 34109 | United States |
| Local Institution - 192 | New Port Richey | Florida | 34655 | United States |
| Local Institution - 214 | New Smyrna Beach | Florida | 32168 | United States |
| Local Institution - 200 | Orlando | Florida | 32810 | United States |
| Local Institution - 076 | Orlando | Florida | 32819 | United States |
| Local Institution - 002 | Palmetto Bay | Florida | 33157 | United States |
| Theia Clinical Research, LLC | Pinellas Park | Florida | 33781 | United States |
| Local Institution - 098 | Port Orange | Florida | 32127 | United States |
| Precision Clinical Research, LLC. | Sunrise | Florida | 33351 | United States |
| Local Institution - 183 | Tampa | Florida | 33612-4799 | United States |
| Apex Clinical Research | Tampa | Florida | 33612 | United States |
| Local Institution - 226 | Tampa | Florida | 33612 | United States |
| Local Institution - 107 | Tampa | Florida | 33614 | United States |
| Local Institution - 149 | Tampa | Florida | 33614 | United States |
| Local Institution - 114 | Weeki Wachee | Florida | 34607 | United States |
| Consultative Gastroenterology | Atlanta | Georgia | 30308 | United States |
| Local Institution - 037 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 220 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 222 | Atlanta | Georgia | 30322 | United States |
| Local Institution - 019 | Atlanta | Georgia | 30342 | United States |
| Local Institution - 063 | Atlanta | Georgia | 30342 | United States |
| Local Institution - 074 | Columbus | Georgia | 31904 | United States |
| Local Institution - 143 | Decatur | Georgia | 30030 | United States |
| Local Institution - 028 | Macon | Georgia | 31201 | United States |
| Local Institution - 115 | Idaho Falls | Idaho | 83404 | United States |
| Local Institution - 194 | Chicago | Illinois | 60612 | United States |
| Local Institution - 036 | Chicago | Illinois | 60622 | United States |
| Local Institution - 022 | Chicago | Illinois | 60637 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Local Institution - 092 | Evansville | Indiana | 47714 | United States |
| Local Institution - 033 | Indianapolis | Indiana | 46202 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| Local Institution - 070 | Topeka | Kansas | 66606 | United States |
| Local Institution - 155 | Lexington | Kentucky | 40536-0298 | United States |
| Local Institution - 020 | Baton Rouge | Louisiana | 70809 | United States |
| CroNOLA LLC | Houma | Louisiana | 70360 | United States |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | United States |
| Clinical Trials of SW Louisiana LLC | Lake Charles | Louisiana | 70601 | United States |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | United States |
| Nola Research Works | New Orleans | Louisiana | 70125 | United States |
| Local Institution - 278 | Baltimore | Maryland | 21224 | United States |
| Local Institution - 129 | Catonsville | Maryland | 21228 | United States |
| Local Institution - 282 | Glen Burnie | Maryland | 21061 | United States |
| Local Institution - 142 | Chestnut Hill | Massachusetts | 02467 | United States |
| Local Institution - 228 | North Worcester | Massachusetts | 01655 | United States |
| Local Institution - 286 | Springfield | Massachusetts | 01199 | United States |
| Local Institution - 024 | Worcester | Massachusetts | 01655 | United States |
| Local Institution - 191 | Caro | Michigan | 48723 | United States |
| Local Institution - 167 | Kalamazoo | Michigan | 49008 | United States |
| Local Institution - 005 | Novi | Michigan | 48377 | United States |
| Local Institution - 108 | Southfield | Michigan | 48034 | United States |
| Local Institution - 301 | Wyoming | Michigan | 49519 | United States |
| Local Institution - 300 | Ypsilanti | Michigan | 48197 | United States |
| Local Institution - 095 | Minneapolis | Minnesota | 55455 | United States |
| Local Institution - 045 | Rochester | Minnesota | 55905 | United States |
| Local Institution - 274 | Jackson | Mississippi | 39216 | United States |
| Local Institution - 198 | Kansas City | Missouri | 64111 | United States |
| Local Institution - 029 | St Louis | Missouri | 63110 | United States |
| Internal Medicine Specialists | Las Vegas | Nevada | 89145 | United States |
| Local Institution - 040 | Lebanon | New Hampshire | 03756 | United States |
| Local Institution - 215 | Englewood | New Jersey | 07631 | United States |
| Local Institution - 144 | Brooklyn | New York | 11235 | United States |
| Local Institution - 009 | Great Neck | New York | 11021 | United States |
| Local Institution - 054 | Hartsdale | New York | 10530 | United States |
| Weill Cornell Medical College | New York | New York | 10010 | United States |
| Concorde Medical Group | New York | New York | 10016 | United States |
| Local Institution - 105 | New York | New York | 10021 | United States |
| TrialSpark | New York | New York | 10024 | United States |
| Local Institution - 043 | New York | New York | 10075 | United States |
| Local Institution - 060 | North Massapequa | New York | 11758-1802 | United States |
| Circuit Clinical | Orchard Park | New York | 14127 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| Local Institution - 017 | Asheville | North Carolina | 28801 | United States |
| Local Institution - 152 | Charlotte | North Carolina | 28204 | United States |
| Local Institution - 055 | Charlotte | North Carolina | 28207 | United States |
| Local Institution - 156 | Charlotte | North Carolina | 28209 | United States |
| Local Institution - 133 | Greenville | North Carolina | 27834 | United States |
| Local Institution - 302 | Raleigh | North Carolina | 27612 | United States |
| Local Institution - 052 | Winston-Salem | North Carolina | 27103 | United States |
| Great Lakes Medical Research, LLC | Beachwood | Ohio | 44122 | United States |
| Local Institution - 291 | Cincinnati | Ohio | 45219 | United States |
| Local Institution - 018 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 170 | Dayton | Ohio | 45417 | United States |
| Local Institution - 049 | Hilliard | Ohio | 43026 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| Local Institution - 141 | Middleburg Heights | Ohio | 44130 | United States |
| Great Lakes Medical Research, LLC | Warren | Ohio | 44483 | United States |
| Local Institution - 087 | Norman | Oklahoma | 73071 | United States |
| Local Institution - 294 | Oklahoma City | Oklahoma | 73102 | United States |
| Local Institution - 208 | Oklahoma City | Oklahoma | 73104 | United States |
| Local Institution - 131 | Oklahoma City | Oklahoma | 73112 | United States |
| Local Institution - 185 | Tulsa | Oklahoma | 74136 | United States |
| Local Institution - 217 | Tulsa | Oklahoma | 74137 | United States |
| Local Institution - 113 | Portland | Oregon | 97239 | United States |
| Local Institution - 197 | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Penn State University Milton S Hershey Medical Center | State College | Pennsylvania | 16803 | United States |
| Local Institution - 253 | Providence | Rhode Island | 02904 | United States |
| Local Institution - 289 | Charleston | South Carolina | 29425 | United States |
| Local Institution - 121 | Nashville | Tennessee | 37211 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Advanced Gastroenterology | Union City | Tennessee | 38261 | United States |
| Local Institution - 158 | Austin | Texas | 78742 | United States |
| Local Institution - 034 | Fort Sam Houston | Texas | 78234 | United States |
| Local Institution - 056 | Houston | Texas | 77030 | United States |
| Local Institution - 150 | Houston | Texas | 77030 | United States |
| Biopharma Informatic Inc. Research Center | Houston | Texas | 77043 | United States |
| Centex Studies, Inc. | Houston | Texas | 77058 | United States |
| GI Specialists of Houston | Houston | Texas | 77070 | United States |
| Local Institution - 303 | Houston | Texas | 77074 | United States |
| Local Institution - 088 | Houston | Texas | 77084 | United States |
| Local Institution - 196 | Houston | Texas | 77089 | United States |
| Gulf Coast Research Group LLC | Houston | Texas | 77098 | United States |
| Accurate Clinical Research Inc | Pasadena | Texas | 77505 | United States |
| Local Institution - 071 | Richardson | Texas | 75082 | United States |
| Local Institution - 085 | San Antonio | Texas | 78215 | United States |
| Local Institution - 223 | San Antonio | Texas | 78229-4894 | United States |
| Local Institution - 178 | San Antonio | Texas | 78229 | United States |
| Local Institution - 007 | Southlake | Texas | 76092 | United States |
| Local Institution - 181 | Temple | Texas | 76508 | United States |
| Local Institution - 073 | Tyler | Texas | 75701 | United States |
| Local Institution - 292 | Riverton | Utah | 84065 | United States |
| Local Institution - 025 | Salt Lake City | Utah | 84132 | United States |
| Local Institution - 189 | Gainesville | Virginia | 20155 | United States |
| Local Institution - 030 | Lynchburg | Virginia | 24502 | United States |
| Local Institution - 298 | Manassas | Virginia | 20110 | United States |
| Summit Clinical Research, LLC | Petersburg | Virginia | 23805 | United States |
| The Gastroenterology Group | Reston | Virginia | 20191 | United States |
| Local Institution - 072 | Richmond | Virginia | 23249 | United States |
| Local Institution - 172 | Roanoke | Virginia | 24016 | United States |
| Virginia Gastroenterology Institute PC | Suffolk | Virginia | 23434 | United States |
| Local Institution - 296 | Williamsburg | Virginia | 23188 | United States |
| Local Institution - 125 | Spokane | Washington | 99204 | United States |
| Aurora Health Care Aurora Research | Grafton | Wisconsin | 53024 | United States |
| Local Institution - 089 | La Crosse | Wisconsin | 54601 | United States |
| Local Institution - 501 | Buenos Aires | 0 | Argentina |
| Local Institution - 494 | Buenos Aires | 1180 | Argentina |
| Local Institution - 571 | Buenos Aires | 1702 | Argentina |
| Local Institution - 500 | Buenos Aires | B1878 | Argentina |
| Local Institution - 570 | Córdoba | X5003DCE | Argentina |
| Local Institution - 495 | Córdoba | X5016 | Argentina |
| Local Institution - 569 | Mar del Plata | B7600 | Argentina |
| Local Institution - 496 | Rosario | 2000 | Argentina |
| Local Institution - 497 | Rosario | 2000 | Argentina |
| Local Institution - 502 | Rosario, Santa Fe | S2002 | Argentina |
| Local Institution - 492 | San Miguel de Tucumán | 4000 | Argentina |
| Local Institution - 310 | Concord | New South Wales | 2139 | Australia |
| Local Institution - 319 | Kingswood | New South Wales | 2747 | Australia |
| Local Institution - 309 | Liverpool | New South Wales | 2170 | Australia |
| Local Institution - 318 | New Lambton Heights | New South Wales | 2305 | Australia |
| Local Institution - 323 | Wollongong | New South Wales | 2500 | Australia |
| Local Institution - 328 | Herston | Queensland | 4029 | Australia |
| Local Institution - 707 | Maroochydore | Queensland | 4558 | Australia |
| Local Institution - 313 | Maroorchydore | Queensland | 4558 | Australia |
| Local Institution - 321 | North Mackay | Queensland | 4740 | Australia |
| Local Institution - 312 | South Brisbane | Queensland | 4101 | Australia |
| Local Institution - 311 | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution - 308 | Adelaide | South Australia | 5000 | Australia |
| Local Institution - 708 | Adelaide | South Australia | 5112 | Australia |
| Local Institution - 307 | Bedford Park | South Australia | 5042 | Australia |
| Local Institution - 326 | Elizabeth Vale | South Australia | 05112 | Australia |
| Local Institution - 320 | Woodville South | South Australia | 5011 | Australia |
| Local Institution - 317 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 305 | Fitzroy | Victoria | 3065 | Australia |
| Local Institution - 329 | Geelong | Victoria | 3220 | Australia |
| Local Institution - 327 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 709 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 316 | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 315 | Subiaco | Western Australia | 6008 | Australia |
| Local Institution - 325 | Bankstown | 2200 | Australia |
| Local Institution - 330 | Box Hill | 3128 | Australia |
| Local Institution - 324 | Sydney, NSW | NSW 2050 | Australia |
| Local Institution - 726 | Innsbruck | 6020 | Austria |
| Local Institution - 727 | Sankt Pölten | 3100 | Austria |
| Local Institution - 336 | Vienna | 1020 | Austria |
| Local Institution - 725 | Vienna | 1090 | Austria |
| Local Institution - 745 | Grodno | 230026 | Belarus |
| Local Institution - 737 | Vitebsk | 210604 | Belarus |
| Local Institution - 943 | Brasschaat | Antwerpen | 2930 | Belgium |
| Local Institution - 940 | Brussels | 1090 | Belgium |
| Local Institution - 939 | Edegem | 2650 | Belgium |
| Local Institution - 937 | Ghent | 9000 | Belgium |
| Local Institution - 942 | Leuven | 3000 | Belgium |
| Local Institution - 936 | Liège | 4000 | Belgium |
| Local Institution - 938 | Seraing | 4100 | Belgium |
| Local Institution - 941 | Tournai | 7500 | Belgium |
| Local Institution - 743 | Banja Luka | 78000 | Bosnia and Herzegovina |
| Local Institution - 741 | Mostar | 88000 | Bosnia and Herzegovina |
| Local Institution - 738 | Sarajevo | 71000 | Bosnia and Herzegovina |
| Local Institution - 742 | Sarajevo | 71000 | Bosnia and Herzegovina |
| Local Institution - 456 | Blagoevgrad | 2700 | Bulgaria |
| Local Institution - 746 | Plovdiv | 4002 | Bulgaria |
| Local Institution - 753 | Rousse | 7002 | Bulgaria |
| Local Institution - 747 | Sofia | 1202 | Bulgaria |
| Local Institution - 750 | Sofia | 1407 | Bulgaria |
| Local Institution - 755 | Sofia | 1407 | Bulgaria |
| Local Institution - 756 | Sofia | 1431 | Bulgaria |
| Local Institution - 627 | Sofia | 1527 | Bulgaria |
| Local Institution - 752 | Sofia | 1527 | Bulgaria |
| Local Institution - 749 | Sofia | 1606 | Bulgaria |
| Local Institution - 554 | Sofia | 1784 | Bulgaria |
| Local Institution - 748 | Sofia | 1784 | Bulgaria |
| Local Institution - 553 | Stara Zagora | 6000 | Bulgaria |
| Local Institution - 754 | Varna | 9002 | Bulgaria |
| Local Institution - 273 | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution - 227 | Edmonton | Alberta | T5R 1W2 | Canada |
| Local Institution - 269 | Edmonton | Alberta | T5R1W2 | Canada |
| Local Institution - 263 | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Local Institution - 262 | New Westminster | British Columbia | V3L 3W5 | Canada |
| Local Institution - 255 | Vancouver | British Columbia | V5Z1M9 | Canada |
| Local Institution - 267 | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Local Institution - 256 | Brandon | Manitoba | R7A 0N7 | Canada |
| Local Institution - 261 | Winnipeg | Manitoba | R3CON2 | Canada |
| Local Institution - 268 | Bridgewater | Nova Scotia | B4V 3N2 | Canada |
| Local Institution - 266 | Greater Sudbury | Ontario | P3C 5K6 | Canada |
| Local Institution - 252 | London | Ontario | N6A 5A5 | Canada |
| Local Institution - 251 | London | Ontario | N6A 5W9 | Canada |
| Local Institution - 264 | Toronto | Ontario | M5G 1X5 | Canada |
| Local Institution - 257 | Toronto | Ontario | M5T 3A9 | Canada |
| Local Institution - 271 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution - 254 | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 270 | Ottawa | Quebec | K1H 8L6 | Canada |
| Local Institution - 389 | Concepción | 4070038 | Chile |
| Local Institution - 392 | Santiago | 7500010 | Chile |
| Local Institution - 387 | Santiago | 7500571 | Chile |
| Local Institution - 391 | Santiago | 7550000 | Chile |
| Local Institution - 390 | Santiago | 8320000 | Chile |
| Local Institution - 423 | Changzhou | Jiangsu | 213003 | China |
| Local Institution - 369 | Shanghai | Shanghai Municipality | 200120 | China |
| Local Institution - 419 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 482 | Beijing | 100050 | China |
| Local Institution - 467 | Beijing | 100700 | China |
| Local Institution - 379 | Bengbu | 233004 | China |
| Local Institution - 485 | Changchun | 130021 | China |
| Local Institution - 376 | Changchun | 130033 | China |
| Local Institution - 421 | Changsha | 410008 | China |
| Local Institution - 378 | Changsha | 450052 | China |
| Local Institution - 414 | Changzhou | 213004 | China |
| Local Institution - 422 | Fuzhou | 350005 | China |
| Local Institution - 478 | Guangzhou | 510030 | China |
| Local Institution - 472 | Guangzhou | 510180 | China |
| Local Institution - 486 | Guangzhou | 510655 | China |
| Local Institution - 470 | Hangzhou, Zhejiang | 100142 | China |
| Local Institution - 491 | Hefei | 230001 | China |
| Local Institution - 374 | Kunming | 650032 | China |
| Local Institution - 383 | Luzhou | 646099 | China |
| Local Institution - 488 | Nanchang | 330006 | China |
| Local Institution - 418 | Nanjing | 210008 | China |
| Local Institution - 375 | Nanjing | 210009 | China |
| Local Institution - 487 | Nanjing | 210029 | China |
| Local Institution - 473 | Shanghai | 200025 | China |
| Local Institution - 380 | Shanghai | 200040 | China |
| Local Institution - 377 | Shanghai | 200080 | China |
| Local Institution - 416 | Shanghai | 200092 | China |
| Local Institution - 458 | Taichung City | 40447 | China |
| Local Institution - 373 | Tianjin | 300052 | China |
| Local Institution - 475 | Wuhan | 430022 | China |
| Local Institution - 474 | Wuhan | 430030 | China |
| Local Institution - 483 | Wuhan | 430060 | China |
| Local Institution - 381 | Wuxi | 214023 | China |
| Local Institution - 415 | Xi'an | 710038 | China |
| Local Institution - 420 | Xi'an | 710100 | China |
| Local Institution - 370 | Zhengzhou | 450014 | China |
| Local Institution - 397 | Armenia | Quindío Department | 630004 | Colombia |
| Local Institution - 398 | Barranquilla | 080020 | Colombia |
| Local Institution - 395 | Bogotá | 110221 | Colombia |
| Local Institution - 396 | Cali | 760026 | Colombia |
| Local Institution - 394 | Medellín | 050034 | Colombia |
| Local Institution - 453 | Koprivnica | 48000 | Croatia |
| Local Institution - 763 | Osijek | 31000 | Croatia |
| Local Institution - 765 | Split | HR-21000 | Croatia |
| Local Institution - 452 | Zagreb | 10000 | Croatia |
| Local Institution - 762 | Zagreb | 10000 | Croatia |
| Local Institution - 766 | Zagreb | 10000 | Croatia |
| Local Institution - 767 | Brno | 615 00 | Czechia |
| Local Institution - 772 | Brno | 656 91 | Czechia |
| Local Institution - 773 | Hradec Králové | 500 12 | Czechia |
| Local Institution - 775 | Most | 43401 | Czechia |
| Local Institution - 771 | Olomouc | 77900 | Czechia |
| Local Institution - 774 | Pardubice | 532 03 | Czechia |
| Local Institution - 769 | Pilsen | 30460 | Czechia |
| Local Institution - 573 | Prague | 120 00 | Czechia |
| Local Institution - 368 | Prague | 14000 | Czechia |
| Local Institution - 776 | Prague | 14021 | Czechia |
| Local Institution - 768 | Prague | 150 06 | Czechia |
| Local Institution - 770 | Prague | 190 00 | Czechia |
| Local Institution - 611 | Copenhagen | 2400 | Denmark |
| Local Institution - 610 | Holbæk | 4300 | Denmark |
| Local Institution - 609 | Nykøbing Falster | 4800 | Denmark |
| Local Institution - 613 | Helsinki | 00290 | Finland |
| Local Institution - 614 | Turku | FI-20521 | Finland |
| Local Institution - 647 | Neuilly-sur-Seine | Cedex | 92200 | France |
| Local Institution - 638 | Amiens | 80054 | France |
| Local Institution - 639 | Béziers | 34525 | France |
| Local Institution - 635 | Blois | 41016 | France |
| Local Institution - 634 | Caen | 14000 | France |
| Local Institution - 644 | Colombes | 92701 | France |
| Local Institution - 711 | Créteil | 94010 | France |
| Local Institution - 616 | Dijon | 21079 | France |
| Local Institution - 615 | Grenoble | 38700 | France |
| Local Institution - 633 | Lillie Cedex | 59037 | France |
| Local Institution - 646 | Marseille | 13915 | France |
| Local Institution - 507 | Montpellier | 34295 | France |
| Local Institution - 632 | Nantes | 44093 | France |
| Local Institution - 630 | Pierre-Bénite | 69495 | France |
| Local Institution - 641 | Rennes | 35033 | France |
| Local Institution - 612 | Rouen | 76031 | France |
| Local Institution - 631 | Saint-Priest-en-Jarez | 42270 | France |
| Local Institution - 643 | Toulouse | 31059 | France |
| Local Institution - 786 | Batumi | 6010 | Georgia |
| Local Institution - 779 | Kutaisi | 4600 | Georgia |
| Local Institution - 248 | Tbilisi | 0101 | Georgia |
| Local Institution - 454 | Tbilisi | 0101 | Georgia |
| Local Institution - 783 | Tbilisi | 0101 | Georgia |
| Local Institution - 247 | Tbilisi | 0112 | Georgia |
| Local Institution - 778 | Tbilisi | 0112 | Georgia |
| Local Institution - 782 | Tbilisi | 0131 | Georgia |
| Local Institution - 552 | Tbilisi | 0144 | Georgia |
| Local Institution - 781 | Tbilisi | 0159 | Georgia |
| Local Institution - 793 | Tbilisi | 0159 | Georgia |
| Local Institution - 740 | Tbilisi | 0160 | Georgia |
| Local Institution - 784 | Tbilisi | 0160 | Georgia |
| Local Institution - 785 | Tbilisi | 0160 | Georgia |
| Local Institution - 335 | Tbilisi | 0179 | Georgia |
| Local Institution - 249 | Tbilisi | 0180 | Georgia |
| Local Institution - 455 | Tbilisi | 0180 | Georgia |
| Local Institution - 780 | Telavi | 2200 | Georgia |
| Local Institution - 626 | Berlin | 10117 | Germany |
| Local Institution - 629 | Berlin | 10787 | Germany |
| Local Institution - 665 | Berlin | 10825 | Germany |
| Local Institution - 653 | Berlin | 12200 | Germany |
| Local Institution - 648 | Berlin | 13353 | Germany |
| Local Institution - 650 | Berlin | 14050 | Germany |
| Local Institution - 628 | Berlin | 14163 | Germany |
| Local Institution - 664 | Brandenburg an der Havel | 14770 | Germany |
| Local Institution - 732 | Dachau | 85221 | Germany |
| Local Institution - 662 | Frankfurt | 60431 | Germany |
| Local Institution - 654 | Frankfurt | 60594 | Germany |
| Local Institution - 574 | Frankfurt am Main | 60313 | Germany |
| Local Institution - 657 | Frankfurt am Main | 60590 | Germany |
| Local Institution - 658 | Halle | 06108 | Germany |
| Local Institution - 656 | Halle | 06120 | Germany |
| Local Institution - 659 | Hamburg | 20246 | Germany |
| Local Institution - 652 | Hamburg | 22559 | Germany |
| Local Institution - 591 | Hanover | 30625 | Germany |
| Local Institution - 649 | Keil | 24105 | Germany |
| Local Institution - 337 | Leipzig | 04103 | Germany |
| Local Institution - 651 | Leipzig | 04103 | Germany |
| Local Institution - 655 | Ludwigshafen am Rhein | 67067 | Germany |
| Local Institution - 730 | Ludwigshafen am Rhein | 67067 | Germany |
| Local Institution - 660 | Mainz | 55131 | Germany |
| Local Institution - 667 | Münster | 48149 | Germany |
| Local Institution - 620 | Neuruppin | 16816 | Germany |
| Local Institution - 584 | Nürtingen | 72622 | Germany |
| Local Institution - 661 | Stuttgart | 70376 | Germany |
| Local Institution - 666 | Tübingen | 72076 | Germany |
| Local Institution - 663 | Ulm | 89081 | Germany |
| Local Institution - 790 | Athens | 11 527 | Greece |
| Local Institution - 588 | Athens | 115 28 | Greece |
| Local Institution - 791 | Athens | 11527 | Greece |
| Local Institution - 792 | Athens | 18536 | Greece |
| Local Institution - 592 | Athens, Attiki | 15562 | Greece |
| Local Institution - 787 | Heraklion | 71 110 | Greece |
| Local Institution - 789 | Thessaloniki | 54642 | Greece |
| Local Institution - 788 | Thessaloniki | 56429 | Greece |
| Local Institution - 404 | Hong Kong | 0 | Hong Kong |
| Local Institution - 405 | Kowloon | 0 | Hong Kong |
| Local Institution - 798 | Békéscsaba | 5600 | Hungary |
| Local Institution - 803 | Budapest | 1062 | Hungary |
| Local Institution - 804 | Budapest | 1088 | Hungary |
| Local Institution - 556 | Budapest | H-1036 | Hungary |
| Local Institution - 801 | Győr | 9024 | Hungary |
| Local Institution - 555 | Gyula | 5700 | Hungary |
| Local Institution - 797 | Miskolc | 3529 | Hungary |
| Local Institution - 800 | Nagykanizsa | H-8800 | Hungary |
| Local Institution - 816 | Szekszárd | 7100 | Hungary |
| Local Institution - 805 | Szentes | 6600 | Hungary |
| Local Institution - 799 | Székesfehérvár | 8000 | Hungary |
| Local Institution - 444 | Hyderabad | Andhra Pradesh | 500084 | India |
| Local Institution - 407 | Surat | Gujarat | 395002 | India |
| Local Institution - 332 | Gurgaon | Haryana | 122002 | India |
| Local Institution - 445 | Kochi | Kerala | 682041 | India |
| Local Institution - 446 | Ludhiana | Punjab | 141001 | India |
| Local Institution - 443 | Jaipur | Rajasthan | 302004 | India |
| Local Institution - 399 | Jaipur | Rajasthan | 302006 | India |
| Local Institution - 408 | Coimbatore | Tamil Nadu | 641044 | India |
| Local Institution - 331 | Hyderabad | Telangana | 500032 | India |
| Local Institution - 457 | Delhi | 110002 | India |
| Local Institution - 411 | New Delhi | 110029 | India |
| Local Institution - 975 | Dublin | Dublin | DO4 T6F4 | Ireland |
| Local Institution - 973 | Dublin | D09 V2N0 | Ireland |
| Local Institution - 343 | Afula | 18341 | Israel |
| Local Institution - 345 | Bat Yam | 5962025 | Israel |
| Local Institution - 346 | Beer Jacob | 73100 | Israel |
| Local Institution - 350 | Haifa | 3109601 | Israel |
| Local Institution - 339 | Jerusalem | 91031 | Israel |
| Local Institution - 347 | Jerusalem | 9362410 | Israel |
| Local Institution - 349 | Kfar Saba | 44281 | Israel |
| Local Institution - 344 | Nahariya | 22100 | Israel |
| Local Institution - 341 | Petah Tikva | 49100 | Israel |
| Local Institution - 342 | Ramat Gan | 52621 | Israel |
| Local Institution - 338 | Rehovot | 76100 | Israel |
| Local Institution - 340 | Tel Aviv | 64239 | Israel |
| Local Institution - 677 | Bologna | 40138 | Italy |
| Local Institution - 684 | Brescia | 25123 | Italy |
| Local Institution - 688 | Brescia | 25124 | Italy |
| Local Institution - 689 | Castellana Grotte | 70013 | Italy |
| Local Institution - 679 | Catanzaro | 88100 | Italy |
| Local Institution - 687 | Chieti | 66100 | Italy |
| Local Institution - 674 | Messina | 98125 | Italy |
| Local Institution - 672 | Milan | 20089 | Italy |
| Local Institution - 686 | Milan | 20122 | Italy |
| Local Institution - 334 | Milan | 20132 | Italy |
| Local Institution - 678 | Monza | 20900 | Italy |
| Local Institution - 685 | Padova | 35128 | Italy |
| Local Institution - 682 | Palermo | 90146 | Italy |
| Local Institution - 673 | Pavia | 27100 | Italy |
| Local Institution - 681 | Roma | 00133 | Italy |
| Local Institution - 675 | Roma | 00168 | Italy |
| Local Institution - 671 | Rome | 00152 | Italy |
| Local Institution - 680 | Udine | 33100 | Italy |
| Local Institution - 670 | Varese | 21100 | Italy |
| Local Institution - 676 | Verona | 37024 | Italy |
| Local Institution - 602 | Riga | LV-1002 | Latvia |
| Local Institution - 601 | Riga | LV-1006 | Latvia |
| Local Institution - 600 | Riga | LV-1038 | Latvia |
| Local Institution - 605 | Kaunas | LT-50009 | Lithuania |
| Local Institution - 603 | Klaipėda | LT-5808 | Lithuania |
| Local Institution - 607 | Vilnius | 08406 | Lithuania |
| Local Institution - 606 | Vilnius | LT-08661 | Lithuania |
| Local Institution - 604 | Vilnius | LT-10207 | Lithuania |
| Local Institution - 526 | Zapapan | Jalisco | 45030 | Mexico |
| Local Institution - 532 | Monterrey | Nuevo León | 64610 | Mexico |
| Local Institution - 525 | Monterrey | Nuevo León | 64718 | Mexico |
| Local Institution - 447 | Monterrey | Nuevo León | C.P 64000 | Mexico |
| Local Institution - 449 | Monterrey | Nuevo León | C.P 64060 | Mexico |
| Local Institution - 529 | Querétaro City | Querétaro | 76070 | Mexico |
| Local Institution - 528 | Chihuahua City | 31020 | Mexico |
| Local Institution - 448 | Mexico City | 6700 | Mexico |
| Local Institution - 527 | México | 07020 | Mexico |
| Local Institution - 530 | Tlalpan | 14080 | Mexico |
| Local Institution - 811 | Chisinau | MD-2068 | Moldova |
| Local Institution - 809 | Chisinau | MD2025 | Moldova |
| Local Institution - 812 | Chisinau | MD2025 | Moldova |
| Local Institution - 813 | Chisinau | MD2025 | Moldova |
| Local Institution - 952 | Amsterdam | 1081 HV | Netherlands |
| Local Institution - 955 | Amsterdam | 1105 AZ | Netherlands |
| Local Institution - 956 | Groningen | 9713 GZ | Netherlands |
| Local Institution - 949 | Nijmegen | 6525 GA | Netherlands |
| Local Institution - 951 | Sittard-Geleen | 6162 BG | Netherlands |
| Local Institution - 954 | Tilburg | 5022 GC | Netherlands |
| Local Institution - 403 | Zamość | Lublin Voivodeship | 22-400 | Poland |
| Local Institution - 597 | Zamość | Lublin Voivodeship | 22-400 | Poland |
| Local Institution - 820 | Bialystok | 15-276 | Poland |
| Local Institution - 818 | Bochnia | 32-700 | Poland |
| Local Institution - 580 | Częstochowa | 42-202 | Poland |
| Local Institution - 988 | Elblag | 82-300 | Poland |
| Local Institution - 579 | Gdansk | 80-382 | Poland |
| Local Institution - 978 | Gdansk | 80-803 | Poland |
| Local Institution - 577 | Gdynia | 81-537 | Poland |
| Local Institution - 906 | Jelenia Góra | 58-500 | Poland |
| Local Institution - 757 | Józefów | 05-410 | Poland |
| Local Institution - 238 | Katowice | 40-040 | Poland |
| Local Institution - 578 | Katowice | 40-040 | Poland |
| Local Institution - 828 | Katowice | 40-660 | Poland |
| Local Institution - 819 | Katowice | 40-752 | Poland |
| Local Institution - 815 | Krakow | 30-363 | Poland |
| Local Institution - 823 | Krakow | 31-156 | Poland |
| Local Institution - 826 | Krakow | 31-501 | Poland |
| Local Institution - 834 | Ksawerów | 95-054 | Poland |
| Local Institution - 817 | Kłodzko | 57-300 | Poland |
| Local Institution - 581 | Lodz | 90-127 | Poland |
| Local Institution - 829 | Lodz | 90-302 | Poland |
| Local Institution - 888 | Lodz | 91-839 | Poland |
| Local Institution - 981 | Lodz | 93-034 | Poland |
| Local Institution - 760 | Lublin | 20-049 | Poland |
| Local Institution - 976 | Nowy Targ | 34-400 | Poland |
| Local Institution - 830 | Olsztyn | 10-561 | Poland |
| Local Institution - 402 | Opole | 45-819 | Poland |
| Local Institution - 400 | Oświęcim | 32-600 | Poland |
| Local Institution - 758 | Poznan | 60-529 | Poland |
| Local Institution - 575 | Poznan | 60-702 | Poland |
| Local Institution - 401 | Poznan | 61-293 | Poland |
| Local Institution - 963 | Rzeszów | 35-302 | Poland |
| Local Institution - 979 | Sopot | 81-756 | Poland |
| Local Institution - 239 | Sopot | 81756 | Poland |
| Local Institution - 835 | Szczecin | 71-270 | Poland |
| Local Institution - 235 | Szczecin | 71434 | Poland |
| Local Institution - 822 | Torun | 87-100 | Poland |
| Local Institution - 824 | Tychy | 43-100 | Poland |
| Local Institution - 827 | Ul. Piotrkowska 177 | 90-447 | Poland |
| Local Institution - 410 | Warsaw | 00-189 | Poland |
| Local Institution - 576 | Warsaw | 01-192 | Poland |
| Local Institution - 833 | Warsaw | 02-018 | Poland |
| Local Institution - 989 | Warsaw | 02-653 | Poland |
| Local Institution - 236 | Warsaw | 04-501 | Poland |
| Local Institution - 586 | Warsaw | 04-501 | Poland |
| Local Institution - 807 | Warsaw | 04-730 | Poland |
| Local Institution - 893 | Wierzchosławice | 33-122 | Poland |
| Local Institution - 983 | Wroclaw | 50-053 | Poland |
| Local Institution - 984 | Wroclaw | 50-367 | Poland |
| Local Institution - 582 | Wroclaw | 50-381 | Poland |
| Local Institution - 982 | Wroclaw | 51-162 | Poland |
| Local Institution - 831 | Wroclaw | 53-114 | Poland |
| Local Institution - 987 | Wroclaw | 53-333 | Poland |
| Local Institution - 832 | Wroclaw | 54-144 | Poland |
| Local Institution - 959 | Coimbra | 3000-075 | Portugal |
| Local Institution - 958 | Guimarães | 4835-044 | Portugal |
| Local Institution - 961 | Loures | 2674-514 | Portugal |
| Local Institution - 957 | Viana do Castelo | 4904-858 | Portugal |
| Local Institution - 808 | Bucharest | 010719 | Romania |
| Local Institution - 836 | Bucharest | 010719 | Romania |
| Local Institution - 499 | Bucharest | 013823 | Romania |
| Local Institution - 795 | Bucharest | 021494 | Romania |
| Local Institution - 837 | Bucharest | 022328 | Romania |
| Local Institution - 839 | Bucharest | 050098 | Romania |
| Local Institution - 842 | Bucharest | 10825 | Romania |
| Local Institution - 838 | Cluj-Napoca | 400001 | Romania |
| Local Institution - 843 | Craiova | 200642 | Romania |
| Local Institution - 840 | Târgu Mureş | 540136 | Romania |
| Local Institution - 871 | Barnaul | 656024 | Russia |
| Local Institution - 589 | Bataysk | 346880 | Russia |
| Local Institution - 621 | Chelyabinsk | 454021 | Russia |
| Local Institution - 991 | Chelyabinsk | 454076 | Russia |
| Local Institution - 598 | Chita | 672090 | Russia |
| Local Institution - 848 | Irkutsk | 664049 | Russia |
| Local Institution - 998 | Kaliningrad | 236016 | Russia |
| Local Institution - 882 | Kaluga | 248007 | Russia |
| Local Institution - 892 | Kazan' | 420103 | Russia |
| Local Institution - 849 | Kemerovo | 650066 | Russia |
| Local Institution - 599 | Khanty-Mansiysk | 628012 | Russia |
| Local Institution - 927 | Krasnoyarsk | 660037 | Russia |
| Local Institution - 566 | Moscow | 105554 | Russia |
| Local Institution - 851 | Moscow | 111123 | Russia |
| Local Institution - 873 | Moscow | 117997 | Russia |
| Local Institution - 870 | Moscow | 119192 | Russia |
| Local Institution - 869 | Moscow | 123423 | Russia |
| Local Institution - 990 | Nizhny Novgorod | 603140 | Russia |
| Local Institution - 594 | Novosibirsk | 630007 | Russia |
| Local Institution - 853 | Novosibirsk | 630091 | Russia |
| Local Institution - 876 | Novosibirsk | 630117 | Russia |
| Local Institution - 996 | Omsk | 644024 | Russia |
| Local Institution - 875 | Orenburg | 460050 | Russia |
| Local Institution - 867 | Penza | 440026 | Russia |
| Local Institution - 858 | Petrozavodsk | 185019 | Russia |
| Local Institution - 859 | Pushkin | 196603 | Russia |
| Local Institution - 960 | Pyatigorsk | 357502 | Russia |
| Local Institution - 846 | Pyatigorsk | 357538 | Russia |
| Local Institution - 863 | Saint Petersburg | 191015 | Russia |
| Local Institution - 993 | Saint Petersburg | 191015 | Russia |
| Local Institution - 862 | Saint Petersburg | 194044 | Russia |
| Local Institution - 868 | Saint Petersburg | 194044 | Russia |
| Local Institution - 847 | Saint Petersburg | 194354 | Russia |
| Local Institution - 857 | Saint Petersburg | 195009 | Russia |
| Local Institution - 845 | Saint Petersburg | 195067 | Russia |
| Local Institution - 856 | Saint Petersburg | 195257 | Russia |
| Local Institution - 879 | Saint Petersburg | 196143 | Russia |
| Local Institution - 878 | Saint Petersburg | 196247 | Russia |
| Local Institution - 874 | Saint Petersburg | 197110 | Russia |
| Local Institution - 865 | Samara | 443001 | Russia |
| Local Institution - 844 | Samara | 443041 | Russia |
| Local Institution - 866 | Sochi | 354207 | Russia |
| Local Institution - 877 | Tomsk | 634063 | Russia |
| Local Institution - 806 | Tula | 300053 | Russia |
| Local Institution - 881 | Ufa | 450005 | Russia |
| Local Institution - 861 | Ufa | 450071 | Russia |
| Local Institution - 855 | Veliky Novgorod | 173008 | Russia |
| Local Institution - 935 | Vladimir | 600023 | Russia |
| Local Institution - 999 | Vladivostok | 690091 | Russia |
| Local Institution - 986 | Vladivostok | 690922 | Russia |
| Local Institution - 880 | Volgograd | 400107 | Russia |
| Local Institution - 583 | Yekaterinburg | 620075 | Russia |
| Local Institution - 872 | Yekaterinburg | 620109 | Russia |
| Local Institution - 534 | Dammam | 32253 | Saudi Arabia |
| Local Institution - 537 | Jeddah | 22252 | Saudi Arabia |
| Local Institution - 536 | Riyadh | 12746 | Saudi Arabia |
| Local Institution - 535 | Riyadh | 14611 | Saudi Arabia |
| Local Institution - 546 | Cape Town | 7500 | Senegal |
| Local Institution - 241 | Belgrade | 11 000 | Serbia |
| Local Institution - 245 | Belgrade | 11 080 | Serbia |
| Local Institution - 887 | Belgrade | 11 080 | Serbia |
| Local Institution - 246 | Belgrade | 11000 | Serbia |
| Local Institution - 596 | Belgrade | 11000 | Serbia |
| Local Institution - 886 | Belgrade | 11000 | Serbia |
| Local Institution - 890 | Belgrade | 11000 | Serbia |
| Local Institution - 891 | Kragujevac | 34000 | Serbia |
| Local Institution - 884 | Novi Sad | 21 000 | Serbia |
| Local Institution - 885 | Pančevo | 26000 | Serbia |
| Local Institution - 585 | Vršac | 26300 | Serbia |
| Local Institution - 889 | Zrenjanin | 23 000 | Serbia |
| Local Institution - 900 | Bratislava | 820 07 | Slovakia |
| Local Institution - 894 | Bratislava | 82606 | Slovakia |
| Local Institution - 895 | Brezno | 97701 | Slovakia |
| Local Institution - 899 | Nitra | 94901 | Slovakia |
| Local Institution - 897 | Nové Zámky | 94002 | Slovakia |
| Local Institution - 898 | Prešov | 080 01 | Slovakia |
| Local Institution - 896 | Rimavská Sobota | 979 01 | Slovakia |
| Local Institution - 904 | Celje | 3000 | Slovenia |
| Local Institution - 543 | Gauteng | 1820 | South Africa |
| Local Institution - 545 | Kempton Park | 1619 | South Africa |
| Local Institution - 544 | Pretoria | 0001 | South Africa |
| Local Institution - 542 | Pretoria | 0084 | South Africa |
| Local Institution - 549 | Pretoria | 0181 | South Africa |
| Local Institution - 548 | Somerset West | 7130 | South Africa |
| Local Institution - 547 | Val de Grace | 0184 | South Africa |
| Local Institution - 437 | Ansan | 152-703 | South Korea |
| Local Institution - 441 | Busan | 49201 | South Korea |
| Local Institution - 434 | Busan | 49241 | South Korea |
| Local Institution - 431 | Busan | 612-030 | South Korea |
| Local Institution - 432 | Daegu | 705-030 | South Korea |
| Local Institution - 435 | Guri-si | 11923 | South Korea |
| Local Institution - 436 | Seongnam-si | 13620 | South Korea |
| Local Institution - 433 | Seoul | 06351 | South Korea |
| Local Institution - 440 | Seoul | 06591 | South Korea |
| Local Institution - 430 | Seoul | 120-752 | South Korea |
| Local Institution - 442 | Seoul | 138-736 | South Korea |
| Local Institution - 438 | Seoul | 3080 | South Korea |
| Local Institution - 427 | Seoul | 3181 | South Korea |
| Local Institution - 439 | Seoul | 7985 | South Korea |
| Local Institution - 429 | Suwon | 442723 | South Korea |
| Local Institution - 703 | Alicante | 03010 | Spain |
| Local Institution - 690 | Badalona | 08916 | Spain |
| Local Institution - 694 | Barcelona | 08022 | Spain |
| Local Institution - 702 | Córdoba | 14001 | Spain |
| Local Institution - 699 | Girona | 17007 | Spain |
| Local Institution - 701 | Las Palmas de Gran Canaria | 35012 | Spain |
| Local Institution - 691 | Madrid | 28006 | Spain |
| Local Institution - 695 | Madrid | 28040 | Spain |
| Local Institution - 692 | Madrid | 28046 | Spain |
| Local Institution - 693 | Majadahonda, Madrid | 28222 | Spain |
| Local Institution - 698 | San Cristóbal de La Laguna | 38320 | Spain |
| Local Institution - 706 | Santander | 39008 | Spain |
| Local Institution - 696 | Seville | 41009 | Spain |
| Local Institution - 705 | Seville | 41013 | Spain |
| Local Institution - 697 | Valencia | 46010 | Spain |
| Local Institution - 700 | Viladecans | 08840 | Spain |
| Local Institution - 625 | Stockholm | 112 81 | Sweden |
| Local Institution - 967 | Bern | 3001 | Switzerland |
| Local Institution - 968 | Sankt Gallen | 9007 | Switzerland |
| Local Institution - 969 | Zurich | 8091 | Switzerland |
| Local Institution - 460 | Kaohsiung City | 82445 | Taiwan |
| Local Institution - 463 | Kaohsiung, San Ming Dist. | 807 | Taiwan |
| Local Institution - 363 | Kozlu | 67000 | Taiwan |
| Local Institution - 461 | Niao-Sung Hsiang Kaohsiung County | 83301 | Taiwan |
| Local Institution - 459 | Tainan, Taiana | 704 | Taiwan |
| Local Institution - 462 | Taoyuan City | 33305 | Taiwan |
| Local Institution - 464 | Tapei, Beitou Dist. | 11217 | Taiwan |
| Local Institution - 465 | Tapei | 10002 | Taiwan |
| Local Institution - 357 | Ankara | 01660 | Turkey (Türkiye) |
| Local Institution - 356 | Ankara | 06590 | Turkey (Türkiye) |
| Local Institution - 360 | Bursa | 16059 | Turkey (Türkiye) |
| Local Institution - 365 | Elâzığ | 23119 | Turkey (Türkiye) |
| Local Institution - 362 | Istanbul | 34093 | Turkey (Türkiye) |
| Local Institution - 358 | Istanbul | 34098 | Turkey (Türkiye) |
| Local Institution - 361 | Istanbul | 34668 | Turkey (Türkiye) |
| Local Institution - 355 | Istanbul | 34840 | Turkey (Türkiye) |
| Local Institution - 354 | Izmit/Kocaeli | 41380 | Turkey (Türkiye) |
| Local Institution - 353 | Kadiköy/Istanbul | 41380 | Turkey (Türkiye) |
| Local Institution - 359 | Trabzon | 61080 | Turkey (Türkiye) |
| Local Institution - 914 | Chernivtsi | 58001 | Ukraine |
| Local Institution - 922 | Chernivtsi | 58001 | Ukraine |
| Local Institution - 950 | Dnipropetrovsk | 49074 | Ukraine |
| Local Institution - 229 | Ivano-Frankivsk | 76008 | Ukraine |
| Local Institution - 929 | Ivano-Frankivsk | 76008 | Ukraine |
| Local Institution - 912 | Ivano-Frankivsk | 76018 | Ukraine |
| Local Institution - 919 | Kharkiv | 61018 | Ukraine |
| Local Institution - 965 | Kharkiv | 61037 | Ukraine |
| Local Institution - 920 | Khmelnytskyi | 29000 | Ukraine |
| Local Institution - 933 | Kropyvnytskyi | 25006 | Ukraine |
| Local Institution - 901 | Kyiv | 01030 | Ukraine |
| Local Institution - 923 | Kyiv | 01601 | Ukraine |
| Local Institution - 915 | Kyiv | 02000 | Ukraine |
| Local Institution - 243 | Kyiv | 02002 | Ukraine |
| Local Institution - 563 | Kyiv | 02002 | Ukraine |
| Local Institution - 911 | Kyiv | 02175 | Ukraine |
| Local Institution - 244 | Kyiv | 03037 | Ukraine |
| Local Institution - 564 | Kyiv | 03037 | Ukraine |
| Local Institution - 918 | Kyiv | 04053 | Ukraine |
| Local Institution - 908 | Kyiv | 04107 | Ukraine |
| Local Institution - 977 | Kyiv | 04107 | Ukraine |
| Local Institution - 562 | Kyiv | 4210 | Ukraine |
| Local Institution - 240 | Lutsk | 43005 | Ukraine |
| Local Institution - 590 | Lutsk | 43005 | Ukraine |
| Local Institution - 234 | Lviv | 79010 | Ukraine |
| Local Institution - 974 | Lviv | 79010 | Ukraine |
| Local Institution - 910 | Lviv | 79059 | Ukraine |
| Local Institution - 242 | Odesa | 65025 | Ukraine |
| Local Institution - 902 | Odesa | 65025 | Ukraine |
| Local Institution - 905 | Poltava | 36011 | Ukraine |
| Local Institution - 934 | Ternopil | 46008 | Ukraine |
| Local Institution - 909 | Vinnytsia | 02029 | Ukraine |
| Local Institution - 932 | Vinnytsia | 21009 | Ukraine |
| Local Institution - 224 | Vinnytsia | 21018 | Ukraine |
| Local Institution - 924 | Vinnytsia | 21018 | Ukraine |
| Local Institution - 971 | Vinnytsia | 21018 | Ukraine |
| Local Institution - 587 | Zaporizhia | 69063 | Ukraine |
| Local Institution - 925 | Zaporizhzhya | 69600 | Ukraine |
| Local Institution - 723 | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Local Institution - 729 | London | LND | NW1 2BU | United Kingdom |
| Local Institution - 557 | Birmingham | B15 2SQ | United Kingdom |
| Local Institution - 714 | Bristol | BS2 8HW | United Kingdom |
| Local Institution - 560 | Cardiff | CF15 9SS | United Kingdom |
| Local Institution - 558 | Chorley | PR7 7NA | United Kingdom |
| Local Institution - 559 | Corbridge Road | NE46 1QJ | United Kingdom |
| Local Institution - 712 | Dundonald | BT16 1RH | United Kingdom |
| Local Institution - 713 | Glasgow | G51 4TF | United Kingdom |
| Local Institution - 716 | Lancashire Blackpool | FY3 8NR | United Kingdom |
| Local Institution - 722 | London | E1 1BB | United Kingdom |
| Local Institution - 715 | London | SE1 9RT | United Kingdom |
| Local Institution - 561 | North Manchester Science Park | M15 6SX | United Kingdom |
| Local Institution - 593 | Shrewsbury | SY38XQ | United Kingdom |
| Local Institution - 718 | Torquay | TQ2 7AA | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| FG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| FG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ozanimod 0.92 mg / Ozanimod 0.92 mg | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation. |
| BG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| BG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Primary | Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 at Week 52 as Observed | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Average Daily Abdominal Pain Score ≤1point and Average Daily Stool Frequency ≤ 3 Points With Abdominal Pain and Stool Frequency no Worse Than Baseline at Week 52 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among All Participants at Maintenance Day 1 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases remaining corticosteroid free in the 12 weeks prior to Week 52 were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Score < 150 at Week 52 in Participants With CDAI Score <150 at Maintenance Day 1 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases with CDAI score <150 at Maintenance Day 1 were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 Points and SES-CD Decrease From Baseline ≥ 2points With no SES-CD Subscore > 1 Point at Week 52 Based on Observed Cases | The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Score < 150 and SES-CD Decrease From Baseline ≥50% at Week 52 Based on Observed Cases and Robarts Observed Scores | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Average Daily AP Score ≤ 1 Point, and Average Daily Stool Frequency Score ≤ 3 Points With AP and SF no Worse Than Baseline and SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore >1 Point at Week 52 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Reduction From Baseline ≥ 100 Points or CDAI Score <150 and SES-CD Decrease From Baseline ≥ 50% at Week 52 | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Reduction From Baseline ≥ 70 Points at Week 52 Based on Observed Cases | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With With CDAI Score < 150 at Week 52, While Remaining Corticosteroid Free in the 12 Weeks Prior to Week 52 Among Subjects Using Corticosteroids at Maintenance Day 1 | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Mucosal Healing (SES-CD ≤ 4 Points and SES-CD Decrease ≥2 Points With no SES-CD Subscore > 1 Point) and Histologic Improvement Based on Robarts Histologic Index (RHI) at Week 52 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Only participants with observed cases were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Time to Relapse (an Increase in CDAI Score From Maintenance Day 1 ≥100 Points and CDAI Score >220, SES-CD ≥ 6 [or ≥4 if Isolated Ileal Disease]), and Exclusion of Other Causes of an Increase in Disease Activity Unrelated to Underlying CD | CDAI is a composite score used to measure the clinical activity of Crohn's disease (CD). It assess 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. 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. | Posted | Median | 95% Confidence Interval | days | Week 52 |
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| Secondary | Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline ≥ 50% at Week 52 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With CDAI Score < 150 at Week 52 and at ≥ 80% of Visits Between Week 8 and Week 52, Inclusive, in Participants With CDAI Score < 150 at Maintenance Day 1 | 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. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Participants with with Clinical Remission at Maintenance Day 1 were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage 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 and SES-CD Decrease From Baseline ≥ 50% at Week 52 | 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. 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. SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. | Intent-To-Treat population included all randomized participants receiving at least 1dose of investigational product. Participants with with Clinical Remission at Maintenance Day 1 were included in the analysis. | Posted | Number | percentage of participants | Week 52 |
|
Adverse events were collected from first dose of Maintenance Study and 90 days after the last dose (up to 731 days). All-cause mortality was collected until 327 weeks.
All-cause mortality, SAEs and Non-SAES were collected for safety population. 1 participant randomized to Placebo/Placebo was actually dosed to Ozanimod 0.92 mg /placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ozanimod 0.92 mg / Ozanimod 0.92 mg | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive ozanimod. Participants were administered 0.23 milligram (mg) of Ozanimod capsule (daily) from Day 1 to Day 4 followed by 0.46 mg of Ozanimod (2 capsules of 0.23 mg daily) from Day 5 to Day 7 followed by 0.92 mg of Ozanimod capsule (daily) till discontinuation. | 1 | 188 | 12 | 188 | 27 | 188 |
| EG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. | 0 | 189 | 17 | 189 | 43 | 189 |
| EG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. | 0 | 173 | 19 | 173 | 34 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Microvascular coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Enterocolonic fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Sep 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607776 | ozanimod |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| BLACK OR AFRICAN AMERICAN |
|
| AMERICAN INDIAN OR ALASKA NATIVE |
|
| ASIAN |
|
| OTHER |
|
| Unknown or Not Reported |
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| Ozanimod 0.92 mg / Placebo |
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation.
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 |
| Ozanimod 0.92 mg / Placebo |
Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|
| OG001 | Ozanimod 0.92 mg / Placebo | Participants who received ozanimod in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation. |
| OG002 | Placebo / Placebo | Participants who received placebo in either RPC01-3201 or RPC01-3202 studies receive placebo orally once daily till discontinuation in blinded fashion. |
|
|
|