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TerminatedNCT03467958Updated Sep 17, 2025Results posted

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

A Phase 3 interventional study of Ozanimod in Crohn Disease, sponsored by Celgene. Terminated at 766 sites in 49 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-17.

Sponsored by Celgene · Phase 3, Interventional, and Treatment

Why this study was terminated
Business objectives have changed
Phase
Phase 3
Study type
Interventional
Enrollment
854
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

02

Conditions studied

  • Crohn Disease

Browse trials for

Keywords

  • Crohn's Disease
  • Crohn Disease
  • Oral
  • Ozanimod
  • Moderately active
  • Severely active
  • RPC01
  • RPC01-3204
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

  • Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
  • Experience relapse or who complete the Maintenance Study
  • Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion criteria

Exclusion Criteria:

  • Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
  • Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
  • Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
854 participants (actual)

Study arms

  • Experimental
    Administration of oral Ozanimod

    Drug: Ozanimod

Interventions

  • DrugOzanimod

    Specified dose on specified days

05

What researchers measure

Primary outcomes

  1. Percentage of Participants With Clinical Remission

    Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. 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.

    Time frame: At weeks 48, 96, 144, 192, 240

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.

    Time frame: From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)

Secondary outcomes

  1. Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission

    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 points 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. Higher scores indicated worse outcomes.

    Time frame: At weeks 48, 96, 144, 192, 240

  2. Percentage of Participants With Clinical Response

    Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \< 150. 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.

    Time frame: At weeks 48, 96, 144, 192, 240

06

Results

Posted Sep 17, 2025

Participant flow

Participant flow — Overall Study
MilestoneRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Started17932966859138332013
Completed000000000
Not completed17932966859138332013
Withdrew: Adverse event20325333650
Withdrew: Lack of efficacy5912069891193
Withdrew: Lost to follow-up121040000
Withdrew: Other reasons8142140101
Withdrew: Pregnancy100001000
Withdrew: Study terminated by sponsor65117456466171155
Withdrew: Withdrawal by subject25447868414

Outcome measures

PrimaryPercentage of Participants With Clinical Remission

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. 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.

Time frame:
At weeks 48, 96, 144, 192, 240
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinical Remission
Percentage of participantsRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Week 4819.621.060.658.856.034.227.320.084.6
Week 9612.312.537.941.238.518.415.215.084.6
Week 1446.17.022.723.518.713.212.1061.5
Week 1924.54.66.111.89.92.63.05.030.8
Week 2402.83.61.53.51.12.605.038.5
PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.

Time frame:
From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
TEAE14024742635226221411
Serious TEAE3859911116422
TEAE leading to discontinuation to study drug30434534751
SecondaryPercentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission

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 points 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. Higher scores indicated worse outcomes.

Time frame:
At weeks 48, 96, 144, 192, 240
Reported as:
Number · Percentage of participants
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission
Percentage of participantsRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Week 4816.221.353.052.945.134.218.220.00
Week 9611.211.637.936.536.318.412.115.00
Week 1445.67.321.224.714.313.212.100
Week 1922.84.96.110.67.72.63.05.00
Week 2403.43.01.51.21.1005.00
SecondaryPercentage of Participants With Clinical Response

Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \< 150. 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.

Time frame:
At weeks 48, 96, 144, 192, 240
Reported as:
Number · Percentage of participants
Percentage of Participants With Clinical Response
Percentage of participantsRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Week 4826.829.262.164.761.536.830.320.084.6
Week 9615.117.343.944.745.118.415.215.084.6
Week 1448.99.422.728.219.813.212.1061.5
Week 1925.06.46.112.911.02.63.05.030.8
Week 2403.94.61.53.52.22.605.038.5

Adverse events

Collected over Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 90 days post the last dose (up to approximately an average of 19 months and a maximum of 65 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RPC01-3201/3202 Placebo0/179 (0%)38/179 (21.2%)104/179 (58.1%)
RPC01-3201/3202 Ozanimod 0.92 mg0/329 (0%)59/329 (17.9%)181/329 (55%)
RPC01-3203 Placebo-Placebo Completers0/66 (0%)9/66 (13.6%)24/66 (36.4%)
RPC01-3203 Ozanimod 0.92 Mg-Placebo Completers0/85 (0%)11/85 (12.9%)44/85 (51.8%)
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Completers1/91 (1.1%)11/91 (12.1%)38/91 (41.8%)
RPC01-3203 Placebo-Placebo Relapse0/38 (0%)6/38 (15.8%)22/38 (57.9%)
RPC01-3203 Ozanimod 0.92 Mg-Placebo Relapse0/33 (0%)4/33 (12.1%)15/33 (45.5%)
RPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg Relapse0/20 (0%)2/20 (10%)14/20 (70%)
RPC01-2201 Ozanimod 0.92 mg0/13 (0%)2/13 (15.4%)10/13 (76.9%)
Most frequent serious events
Showing 10 of 97
Most frequent serious events
EventRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Crohn's diseaseGastrointestinal disorders22/17924/3291/663/852/914/383/331/200/13
Small intestinal obstructionGastrointestinal disorders1/1791/3292/660/850/910/380/330/201/13
Ureteric stenosisRenal and urinary disorders0/1790/3290/660/850/910/380/330/201/13
Spinal osteoarthritisMusculoskeletal and connective tissue disorders0/1790/3290/660/850/910/380/331/200/13
Acute kidney injuryRenal and urinary disorders0/1790/3290/660/850/910/381/330/200/13
Intestinal obstructionGastrointestinal disorders0/1790/3291/660/850/911/380/330/200/13
Anal abscessInfections and infestations1/1790/3290/660/850/911/380/330/200/13
ThrombocytopeniaBlood and lymphatic system disorders0/1790/3291/660/850/910/380/330/200/13
LeptospirosisInfections and infestations0/1790/3291/660/850/910/380/330/200/13
Pelvic abscessInfections and infestations0/1790/3291/660/850/910/380/330/200/13
Most frequent other events
Showing 10 of 81
Most frequent other events
EventRPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mg
Crohn's diseaseGastrointestinal disorders33/17936/3293/667/856/918/384/335/200/13
COVID-19Infections and infestations16/17925/3295/669/8515/913/385/331/203/13
PneumoniaInfections and infestations2/1791/3290/661/851/910/380/331/202/13
SinusitisInfections and infestations4/1799/3290/661/851/912/380/330/202/13
Back painMusculoskeletal and connective tissue disorders2/1795/3292/661/850/910/381/330/202/13
NephrolithiasisRenal and urinary disorders2/1791/3290/660/850/911/380/330/202/13
RhinorrhoeaRespiratory, thoracic and mediastinal disorders1/1791/3291/660/850/911/380/330/202/13
LymphopeniaBlood and lymphatic system disorders13/17943/3293/667/8510/914/383/331/200/13
Abdominal painGastrointestinal disorders10/17918/3294/664/852/912/382/332/200/13
AnaemiaBlood and lymphatic system disorders7/17917/3293/668/854/911/382/330/200/13

Baseline characteristics

Age, Continuous
Age, Continuous(Years)RPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mgTotal
Mean37.93 ± 13.14739.21 ± 13.50840.80 ± 13.98838.21 ± 13.81941.98 ± 13.11634.84 ± 11.10038.06 ± 12.68639.30 ± 14.69744.00 ± 10.36839.10 ± 13.360
Sex: Female, Male
Sex: Female, Male(Participants)RPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mgTotal
Female781513136481412117388
Male101178354943242196466
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)RPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mgTotal
Hispanic or Latino813434200135
Not Hispanic or Latino16830962818635292012802
Unknown or Not Reported37011140017
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RPC01-3201/3202 PlaceboRPC01-3201/3202 Ozanimod 0.92 mgRPC01-3203 Placebo-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Placebo CompletersRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg CompletersRPC01-3203 Placebo-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Placebo RelapseRPC01-3203 Ozanimod 0.92 Mg-Ozanimod 0.92 mg RelapseRPC01-2201 Ozanimod 0.92 mgTotal
American Indian or Alaska Native0000100001
Asian1635355321070
Native Hawaiian or Other Pacific Islander0100000001
Black or African American2210101018
White15327461778234271912739
More than one race0000000000
Unknown or Not Reported817132130035
07

Study locations

766 sites
  • Holland Center for Family Health
    Peoria, Arizona 85381, United States
  • Local Institution - 202
    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
  • Local Institution - 112
    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
  • Local Institution - 216
    Oak Lawn, Illinois 60453-3767, 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

Showing the first 100 of 766 sites across 49 countries.

08

References and documents

Publications

  • Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5. PubMed 36208720 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 16, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03467958
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Mar 16, 2018
Start date
Aug 24, 2018
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Results posted
Sep 17, 2025
Last update
Sep 17, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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