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

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ClinicalTrials.gov Identifier: NCT03440372
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a Phase 3, randomized, double-blind, placebo-controlled study to explore the effect of oral ozanimod as an induction treatment for subjects with moderately to severely active Crohn's Disease.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ozanimod Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : April 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Administration of oral Ozanimod
Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation
Drug: Ozanimod
Ozanimod

Placebo Comparator: Administration of Placebo
Subjects will receive placebo capsule orally starting with a 7-day dose escalation
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of subjects with a CDAI score < 150 [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.


Secondary Outcome Measures :
  1. Proportion of subjects 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 [ Time Frame: Week 12 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.

  2. Proportion of subjects with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The SES-CD assesses the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing.

  3. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  4. Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

  5. Proportion of subjects with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of inflammation.

  6. Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points at week 12 [ Time Frame: Up to approximately week 12 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

  7. Proportion of subjects with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% at week 12. [ Time Frame: Up to approximately week 12 ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary. The SES-CD assesses the degree of inflammation.

  8. Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes (Geboes, 2000) [ Time Frame: Week 12 ]
    Global Histologic Disease Activity score is a measure of histologic inflammation.

  9. Proportion of subjects with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.

  10. Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.

  11. Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
    The CDEIS assesses the degree of endoscopic inflammation.

  12. Proportion of adolescent subjects with clinical remission, defined as Pediatric Crohn's Disease Activity Index (PCDAI) ≤ 10 points at week 12 [ Time Frame: Up to approximately week 12 ]
    The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

  13. Proportion of adolescent subjects with clinical response, defined as a decrease in PCDAI ≥ 15 points from baseline [ Time Frame: Up to approximately week 12 ]
    The PCDAI is an instrument that was developed and validated for numerical assessment of disease activity in children and adolescents with CD (Hyams, 1991). The PCDAI includes subjective patient historical information, physical examination findings, objective laboratory parameters, data on weight gain/loss, and height velocity.

  14. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) scores (adult subjects only) [ Time Frame: Up approximately Week 12 ]
    The IBDQ is a frequently used outcome parameter in clinical trials. The IBDQ is a responsive instrument for reflection quick change in the quality of life of patients with CD, within a 2-week period. The IBDQ has evolved into a standard for measuring disease-specific quality of life in patients with CD.

  15. Change from baseline in 36-Item Short Form-36 Survey (SF-36) scores (adult subjects only) [ Time Frame: Up to approximately week 12 ]
    The medical outcomes SF-36 questionnaire provides a measure of the subject's health status.

  16. Change from baseline in Work Productivity and Activity Impairment questionnaire for Crohn's disease (WPAI-CD) scores (adult subjects only) [ Time Frame: Up to approximately week 12 ]
    The WPAI-CD is a validated, reliable and responsive instrument that assesses the impact of CD on work and activity.

  17. Change from baseline in EuroQol 5 dimensions questionnaire (EQ- 5D) scores [ Time Frame: Up to approximately week 12 ]
    The EQ-5D is a validated, 6-item, self-administered instrument designed to measure generic health status.

  18. Differences in CD-related hospitalizations, procedures, and surgery [ Time Frame: Week 12 ]
    Healthcare Resource Utilization (HRU) will be evaluated in this study to assess the impact of CD and health-related outcomes (hospitalizations, emergency department or urgent care clinic visits, procedures, and physician visits).

  19. Assessment of circulating lymphocyte concentration [ Time Frame: Up to approximately week 12 ]
    T and B cell panels consisting of Treg cells, naïve T and B cells, memory cells and plasmablasts are evaluated for assessment of immune status.

  20. Assessment of gene expression [ Time Frame: Up to approximately week 12 ]
    Interferon signature are assessed in the blood and in colon biopsies to evaluate differences based on disease activity.

  21. Assessment of protein biomarker concentration [ Time Frame: Up to approximately week 12 ]
    Protein biomarkers such as high-density lipoprotein, C-reactive protein, fecal calprotectin, Immunoglobulin A (IgA) are measured in addition to assessing clinical endpoints to help evaluate disease activity.

  22. Assessment of pharmacogenetics [ Time Frame: Up to approximately week 12 ]
    Markers such as Interferon Regulatory Factor 5 are evaluated to better understand genetic variations that could lead to differences in response to Ozanimod.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Aged 12-75 years 2. Crohn's disease for ≥ 3 months on endoscopy and on histological exam 3. Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy 4. Patient has met each of the following clinical and endoscopic criteria:

  1. Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450.
  2. Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points.
  3. SES-CD score of ≥ 6 (or SES-CD ≥ 4 in subjects with isolated ileal disease).

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment or at the time point specified in the following criteria:

  1. Subject has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation, requiring procedural intervention, or with obstructive symptoms. In addition, subjects with colonic or ileal strictures that are not passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal valve that are fibrotic in nature, will be excluded.
  2. Current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgement, surgical or medical intervention within 12 weeks of entry into the study, or need for ileostomy or colostomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440372


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

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Locations
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United States, Arizona
Holland Center for Family Health Recruiting
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC Not yet recruiting
Phoenix, Arizona, United States, 85018
United States, Arkansas
Arkansas Gastroenterology, P.A. Recruiting
North Little Rock, Arkansas, United States, 72117
United States, California
Sharp Chula Vista Medical Center Recruiting
Chula Vista, California, United States, 91911
Valley View Internal Medicine Recruiting
Garden Grove, California, United States, 92843
San Diego Clinical Trials Recruiting
La Mesa, California, United States, 91942
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Gastrointestinal Biosciences Recruiting
Los Angeles, California, United States, 90067
VA Northern California Health Care System Not yet recruiting
Mather, California, United States, 95655
ABS Health, LLC Recruiting
Mission Viejo, California, United States, 92691
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
Palo Alto Center-Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94304
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Medical Associates Research Group Recruiting
San Diego, California, United States, 92123
United States, Colorado
Childrens Hospital Colorado Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Gastro Florida Recruiting
Clearwater, Florida, United States, 33756-3839
University of Florida Health Endocrinology - Medical Specialties - Medical Plaza Not yet recruiting
Gainesville, Florida, United States, 32608
Qway Research LLC Recruiting
Hialeah, Florida, United States, 33010
Floridian Clinical Research LLC Recruiting
Hialeah, Florida, United States, 33016
Harmony Medical Research Institute Recruiting
Hialeah, Florida, United States, 33016
The Center for Gastrointestinal Disorders Recruiting
Hollywood, Florida, United States, 33021
Vista Health Research Recruiting
Homestead, Florida, United States, 33033
Florida Center for Gastroenterology Recruiting
Largo, Florida, United States, 33777
Nova Clinical Research Center LLC Recruiting
Miami, Florida, United States, 33125
LCC Medical Research Institute, LLC Recruiting
Miami, Florida, United States, 33126
Research Associates of South Florida LLC Recruiting
Miami, Florida, United States, 33156
Advanced Research for Health Improvement Recruiting
Naples, Florida, United States, 34109
NSB Research Recruiting
New Smyrna Beach, Florida, United States, 32168
HMD Research LLC Recruiting
Orlando, Florida, United States, 32819
Advanced Medical Research Center Recruiting
Port Orange, Florida, United States, 32127
Asclepes Research Centers Recruiting
Weeki Wachee, Florida, United States, 34607
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Consultative Gastroenterology Recruiting
Atlanta, Georgia, United States, 30308
Atlanta Gastroenterology Associates, LLC Recruiting
Atlanta, Georgia, United States, 30342
Children's Center for Digestive Healthcare Recruiting
Atlanta, Georgia, United States, 30342
Gastrointestinal Disease Research Recruiting
Columbus, Georgia, United States, 31904
Gastroenterology Associates Of Central Georgia LLC Recruiting
Macon, Georgia, United States, 31201
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Rush University Medical Center - University Cardiovascular Surgeons Recruiting
Chicago, Illinois, United States, 60612
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60622
Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
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Iowa Digestive Disease Center Recruiting
Clive, Iowa, United States, 50325
United States, Kentucky
University of Kentucky Health Care Recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
CroNOLA LLC Recruiting
Houma, Louisiana, United States, 70360
Centex Studies, Inc. Recruiting
Lake Charles, Louisiana, United States, 70601
Nola Research Works Recruiting
New Orleans, Louisiana, United States, 70125
LSU Health Sciences Center Shreveport Not yet recruiting
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins Bayview Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21224
Digestive Disease Associates, PA Recruiting
Catonsville, Maryland, United States, 21228
United States, Massachusetts
Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - The Center for Vascular Biol Not yet recruiting
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital - Crohn's and Colitis Center Recruiting
Chestnut Hill, Massachusetts, United States, 02467
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Medex Research Institute Recruiting
Caro, Michigan, United States, 48723
Revive Research Institute Recruiting
Southfield, Michigan, United States, 48034
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Southern Therapy and Advanced Research Not yet recruiting
Jackson, Mississippi, United States, 39216
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Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
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Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
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Albuquerque, New Mexico, United States, 87106
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Brooklyn, New York, United States, 11230
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Brooklyn, New York, United States, 11235
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Fishkill, New York, United States, 12524
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Glens Falls, New York, United States, 12801
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Great Neck, New York, United States, 11021
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New York, New York, United States, 10021
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Circuit Clinical Recruiting
Orchard Park, New York, United States, 14127
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Asheville Gastroenterology Associates, P.A. Recruiting
Asheville, North Carolina, United States, 28801
Carolinas HealthCare System Digestive Health Recruiting
Charlotte, North Carolina, United States, 28204
Internal Medicine Research Recruiting
Charlotte, North Carolina, United States, 28207
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Greenville, North Carolina, United States, 27834
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Great Lakes Medical Research, LLC Recruiting
Beachwood, Ohio, United States, 44122
Cleveland Clinic - Taussig Cancer Institute Recruiting
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
Great Lakes Medical Research, LLC Recruiting
Warren, Ohio, United States, 44483
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University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Digestive Disease Specialists Inc. Not yet recruiting
Oklahoma City, Oklahoma, United States, 73109
Digestive Disease Specialists Recruiting
Oklahoma City, Oklahoma, United States, 73112
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Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
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Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Penn State University Milton S Hershey Medical Center Recruiting
State College, Pennsylvania, United States, 16803
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Quality Medical Research Recruiting
Nashville, Tennessee, United States, 37211
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Advanced Gastroenterology Recruiting
Union City, Tennessee, United States, 38261
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Avant Research Associates, LLC - Austin Recruiting
Austin, Texas, United States, 78704
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Biopharma Informatic Inc. Research Center Recruiting
Houston, Texas, United States, 77043
GI Specialists of Houston Recruiting
Houston, Texas, United States, 77070
Premier Vein and Vascular Center Recruiting
Houston, Texas, United States, 77084
Ygenics Not yet recruiting
Plano, Texas, United States, 75093
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San Antonio, Texas, United States, 78215
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Southlake, Texas, United States, 76092
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Tyler, Texas, United States, 75701
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University of Utah School of Medicine Not yet recruiting
Salt Lake City, Utah, United States, 84132
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Gastroenterology Associates, PC Recruiting
Gainesville, Virginia, United States, 20155
Summit Clinical Research, LLC Recruiting
Petersburg, Virginia, United States, 23805
Virginia Gastroenterology Institute PC Recruiting
Suffolk, Virginia, United States, 23434
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University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Dermatologist Specialists of Spokane Recruiting
Spokane, Washington, United States, 99204
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Aurora Health Care Aurora Research Recruiting
Grafton, Wisconsin, United States, 53024
Argentina
Sanatorio Guemes Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, 1180
Cemic Saavedra Not yet recruiting
Ciudad Autónoma De Buenos Aires, Argentina, 1431
Hospital Privado Centro Medico de Cordoba Recruiting
Cordoba, Argentina, X5016
Instituto Medico de la Fundacion Estudios Clinicos Recruiting
Rosario, Argentina, 2000
Universidad Nacional De Rosario - Hospital Provincial Del Centenario Recruiting
Rosario, Argentina, 2000
Sanatorio 9 de Julio - CICE 9 de Julio Recruiting
San Miguel de Tucuman, Argentina, 4000
Australia, New South Wales
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Wollongong Hospital Not yet recruiting
Wollongong, New South Wales, Australia, 2500
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Royal Brisbane and Women's Hospital Not yet recruiting
Herston, Queensland, Australia, 4029
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
Harry Perkins Medical Research Institute, Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Australia
Ballarat Base Hospital Not yet recruiting
Ballarat, Australia, 3350
Belarus
Grodno City Clinical Hospital #4 Recruiting
Grodno, Belarus, 230026
Vitebsk Regional Clinical Specialized Center Recruiting
Vitebsk, Belarus, 210604
Belgium
Algemeen Ziekenhuis Klina Recruiting
Brasschaat, Belgium, 2930
Universitair Ziekenhuis Brussel Not yet recruiting
Brussels, Belgium, 1090
Universitair Ziehenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent Recruiting
Ghent, Belgium, 9000
Universitair Ziekenhuis Leuven, Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
CHC - Clinique St-Jospeh Recruiting
Liege, Belgium, 4000
Sart Tilman Hospital Department of Gastroenterology and Hepatology Recruiting
Seraing, Belgium, 4100
Hospital Centre of Walloon Picarde Recruiting
Tournai, Belgium, 7500
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska Recruiting
Banja Luka, Bosnia and Herzegovina, 78000
University Clinical Hospital Mostar Recruiting
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
General Hospital "Prim.dr. Abdulah Nakas" Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
CDC - Centro Digestivo de Curitiba Not yet recruiting
Curitiba, Paraná, Brazil, 80430-180
Hospital Nossa Senhora das Gracas Not yet recruiting
Curitiba, Paraná, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre (HCPA) Not yet recruiting
Porto Algere, Rio Grande Do Sul, Brazil, 90035-903
Pesquisare Saude Not yet recruiting
Santo Andre, São Paulo, Brazil, 09080-110
Kaiser Clinica Not yet recruiting
Sao Jose do Rio Preto, São Paulo, Brazil, 15015-110
Santa Casa De Votuporanga-Philanthropic hospital Not yet recruiting
Votuporanga, São Paulo, Brazil, 15500-003
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo Not yet recruiting
Passo Fundo, Brazil, 99010
Ribeiralo Preto Medical School, University of Salo Paulo Not yet recruiting
Ribeirao Preto, Brazil, 14048-900
Universidade Federal do Estado do Rio de Janeiro (UNIRIO) - Hospital Universitario Gaffree e Guinle Not yet recruiting
Rio de Janeiro, Brazil, 20270-004
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF) Not yet recruiting
Rio de Janeiro, Brazil, 21941
CEMEC - Centro Multidisciplinar De Estudos Clanicos Not yet recruiting
Santo Andre, Brazil, 09190-510
Bulgaria
Multiprofile Hospital for Active Treatment Medline Recruiting
Plovdiv, Bulgaria, 4002
Second MHAT Sofia AD Recruiting
Sofia, Bulgaria, 1202
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Recruiting
Sofia, Bulgaria, 1606
University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia Recruiting
Sofia, Bulgaria, 1784
ACIBADEM City Clinic Medical Center Bregalnitsa Recruiting
Varna, Bulgaria, 9002
Canada, Alberta
University of Calgary Health - The Gastrointestinal Research Group (GIRG) Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Okanagan Clinical Trials Ltd Completed
Kelowna, British Columbia, Canada, V1Y 1Z9
Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Manitoba
Winnipeg Clinic Dermatology Research Recruiting
Winnipeg, Manitoba, Canada, R3CON2
Canada, Nova Scotia
Viable Clinical Research Recruiting
Bridgewater, Nova Scotia, Canada, B4V 3N2
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
LHSC Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Toronto Digestive Disease Associates Inc Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Croatia
Clinical Hospital Center Osijek Recruiting
Osijek, Croatia, 31000
Clinical Hospital Centre Rijeka Recruiting
Rijeka, Croatia, 51000
Clinical Hospital Center Split Recruiting
Split, Croatia, HR-21000
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases Recruiting
Zagreb, Croatia, 10000
Clinical Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
University Hospital Centre Zagreb, Clinic of Internal Diseases Recruiting
Zagreb, Croatia, 10000
Czechia
Military Hospital Brno Recruiting
Brno, Czechia, 615 00
St. Anne's University Hospital Brno Recruiting
Brno, Czechia, 656 91
Hepato-Gastroenterologie HK, s. r. o. Recruiting
Hradec Králové, Czechia, 500 12
Soukroma Gastroenterologicka ambulance a endoskopie Recruiting
Most, Czechia, 43401
PreventaMed Recruiting
Olomouc, Czechia, 77900
Krajská nemocnice Pardubice, Kožní oddelení Recruiting
Pardubice, Czechia, 532 03
University Hospital Pilsen Recruiting
Plzen, Czechia, 30460
University Hospital Motol Recruiting
Prague 5, Czechia, 150 06
Institut klinicke a experimentalni mediciny Recruiting
Praha 4, Czechia, 14021
IBD Centrum/ISCARE IVF a.s. Recruiting
Praha 7, Czechia, 17004
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Holbaek Hospital Recruiting
Holbaek, Denmark, 4300
Nykobing F Hospital Recruiting
Nykobing F, Denmark, 4800
Germany
Charite - Universitaetsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Gastroenterology Am Bayerischen Platz Recruiting
Berlin, Germany, 10825
DRK Clinics Berlin Recruiting
Berlin, Germany, 14050
Agaplesion Markus Krankenhaus Recruiting
Frankfurt, Germany, 60431
Interdisciplinary Crohn Colitis Center Rhein Main Recruiting
Frankfurt, Germany, 60594
University Hospital Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Universitaetsklinikum Leipzig AoeR Recruiting
Leipzig, Germany, 04103
Practice for Gastroenterology and Internal Medicine Recruiting
Ludwigshafen am Rhein, Germany, 67067
Synesis Research Center Not yet recruiting
Munich, Germany, 80331
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, 72076
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Ireland
St Vincent's University Hospital Recruiting
Dublin 4, Dublin, Ireland, DO4 T6F4
Beaumont Hospital Recruiting
Dublin 9, Ireland, D09 V2N0
Israel
Bat Yamon Medical Center, Clalit Medical Services Recruiting
Bat Yam, Israel, 5962025
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Galilee Medical Center Recruiting
Nahariya, Israel, 22100
The Nazareth Hospital E.M.M.S. Not yet recruiting
Nazareth, Israel, 16100
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Kaplan Medical Center Recruiting
Rechovot, Israel, 76100
Italy
University Polyclinic Hospital of Bari Not yet recruiting
Bari, Italy, 70124
Polyclinic S. Orsola-Malpighi Not yet recruiting
Bologna, Italy, 40138
Civil Hospital of Brescia Recruiting
Brescia, Italy, 25123
Poliambulanza Hospital Recruiting
Brescia, Italy, 25124
IRCCS "Savario De Bellis" Not yet recruiting
Castellana Grotte, Italy, 70013
University Hospital Mater Domini Recruiting
Catanzaro, Italy, 88100
"Ss. Annunziata" Policlinic of Chieti Recruiting
Chieti, Italy, 66100
University Polyclinic Hospital G. Martino Recruiting
Messina, Italy, 98125
Maggiore Polyclinic Hospital, IRCCS Ca' Granda Recruiting
Milano, Italy, 20122
Humanitas Research Hospital - Humanitas Mirasole S.p.A Recruiting
Milan, Italy, 20089
Azienda Socio Sanitaria Territoriale (ASST) di Monza Recruiting
Monza, Italy, 20900
Hospital of Di Padova Recruiting
Padova, Italy, 35128
United Hospitals Villa Sofia Cervello Recruiting
Palermo, Italy, 90146
Polyclinic San Matteo IRCCS Not yet recruiting
Pavia, Italy, 27100
Polyclinic Tor Vergata Recruiting
Roma, Italy, 00133
Univerisity Polyclinic Foundation Agostino Gemelli Recruiting
Roma, Italy, 00168
Azienda Ospedaliera San Camillo Forlanini Recruiting
Rome, Italy, 00152
Integrated University Hospital Santa Maria della Misericordia of Udine Recruiting
Udine, Italy, 33100
A.O. Universitaria Fondazione Macchi Recruiting
Varese, Italy, 21100
Sacred Heart Don Calabria Recruiting
Verona, Italy, 37024
Korea, Republic of
Korea University Medical Center - Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of, 152-703
Hanyang University Guri Hospital Recruiting
Guri-si, Korea, Republic of, 11923
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 3181
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 7985
Latvia
P. Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV-1002
Digestive Diseases Center Gastro Recruiting
Riga, Latvia, LV-1006
Riga East Clinical University Hospital clinic Gailezers Recruiting
Riga, Latvia, LV-1038
Mexico
Hospital Dalinde - CECRA Clinica Especializada en Colon, Recto y Ano Not yet recruiting
Delegacion Cuauhtemoc, Distrito Federal, Mexico, 06760
Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. Recruiting
Zapapan, Jalisco, Mexico, 45030
Centro Regiomontano de Estudios Clinicos Roma SC. Recruiting
Monterrey, Nuevo León, Mexico, 64610
Instituto Tecnológico y de Estudios Superiores de Monterrey Recruiting
Monterrey, Nuevo León, Mexico, 64718
SMIQ Recruiting
Santiago de Queretaro, Querétaro, Mexico, 76070
Hospital Christus Muquerza del Parque S.A. de C.V. Recruiting
Chihuahua, Mexico, 31020
Centro de Investigacion Clinica Acelerada (CICA) S.C. Recruiting
Mexico, Mexico, 07020
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Tlalpan, Mexico, 14080
Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital Recruiting
Chisinau, Moldova, Republic of, MD-2068
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery Recruiting
Chisinau, Moldova, Republic of, MD2005
"Sf. Arhanghel Mihail" Municipal Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Republican Clinical Hospital, Department of Colorectal Surgery Recruiting
Chisinau, Moldova, Republic of, MD2025
Republican Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Norway
Akershus University Hospital Not yet recruiting
Lørenskog, Norway, 1478
Lovisenberg Diakonale Sykehus Not yet recruiting
Oslo, Norway, 0440
Poland
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego Recruiting
Bialystok, Poland, 15-276
Medical Services Center MaxMed Recruiting
Bochnia, Poland, 32-700
Nzoz All-Medicus Recruiting
Katowice, Poland, 40-660
Kornel Gibinski Independent Public Central Clinical Hospital in Katowice Recruiting
Katowice, Poland, 40-752
GLOBE Clinical Research Sp. z o.o. LLC Recruiting
Klodzko, Poland, 57-300
PLEJADY Sp. z o.o. (LLC) Medical Centre Recruiting
Krakow, Poland, 30-363
Landa Specialist Doctor's Offices Recruiting
Krakow, Poland, 31-156
Krakow Medical Center LLC Recruiting
Krakow, Poland, 31-501
Santa Familia Centrum Badan, Profilaktyki i Leczenia Recruiting
Lodz, Poland, 90-302
Salve Medica Recruiting
Lodz, Poland, 91-211
1 Military Clinical Hospital in Lublin Recruiting
Lublin, Poland, 20-049
Provincial Specialist Hospital in Olsztyn Recruiting
Olsztyn, Poland, 10-561
SOLUMED Medical Center Recruiting
Poznan, Poland, 60-529
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe Recruiting
Torun, Poland, 87-100
H-T. Medical Center Sp. z o.o. LLC Limited Partnership Recruiting
Tychy, Poland, 43-100
Polimedica Recruiting
Ul. Piotrkowska 177, Poland, 90-447
Maternal Pediatric and Adolescent Healthcare Centre Recruiting
Warsaw, Poland, 00-632
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Recruiting
Warszawa, Poland, 03-580
Romania
Hyperclinica MedLife Grivita Recruiting
Bucharest, Romania, 010719
Center of Diagnosis and Treatment Provita Recruiting
Bucharest, Romania, 021494
Fundeni Clinical Institute Recruiting
Bucharest, Romania, 022328
Bucharest University Emergency Hospital, Department of Internal Medicine II Recruiting
Bucharest, Romania, 050098
Dr. Carol Davila Central Military Emergency Clinical Hospital Recruiting
Bucharest, Romania, 10825
Craiova County Emergency Clinical Hospital Recruiting
Craiova, Romania, 200642
Colentina Clinical Hospital Recruiting
Napoca, Romania, 400001
Targu Mures County Emergency Clinical Hospital Recruiting
Targu Mures, Romania, 540136
Russian Federation
Irkutsk State Medical Academy of Postgraduate Education Recruiting
Irkutsk, Russian Federation, 664049
Moscow Clinical Scientific and Practical Center Recruiting
Moscow, Russian Federation, 111123
Republican Hospital na VA Baranov Recruiting
Petrozavodsk, Russian Federation, 185019
Evromedservis Recruiting
Pushkin, Russian Federation, 196603
Clinic UZI 4D, LLC Recruiting
Pyatigorsk, Russian Federation, 357502
Pyatigorsk City Hospital 2 Recruiting
Pyatigorsk, Russian Federation, 357538
Rostov State Medical University Recruiting
Rostov-on-Don, Russian Federation, 344022
Medical Center Reavita Med Spb LLC Terminated
Saint Petersburg, Russian Federation, 194354
Samara Station Railway Clinical Hospital under OAO Russian Railways Recruiting
Samara, Russian Federation, 443041
S.M. Kirov Military Medical Academy Recruiting
St Petersburg, Russian Federation, 194044
Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office Recruiting
St. Petersburg, Russian Federation, 195067
SPb SBIH City Hospital of Saint Martyr Elizaveta Recruiting
St. Petersburg, Russian Federation, 195257
SPb SBIH City Hospital # 9 Not yet recruiting
St. Petersburg, Russian Federation, 197110
City Clinical Hospital #21 Recruiting
Ufa, Russian Federation, 450071
Novgorod Regional Clinical Hospital Recruiting
Veliky Novgorod, Russian Federation, 173008
Primorsky Regional Clinical Hospital No.1 Recruiting
Vladivostok, Russian Federation, 690091
Medical Center of Far-Eastern Federal University Recruiting
Vladivostok, Russian Federation, 690922
Saudi Arabia
King Fahad Specialist Hospital Not yet recruiting
Dammam, Saudi Arabia, 32253
King Abdul Aziz University Hospital Recruiting
Jeddah, Saudi Arabia, 22252
King Saud Medical Complex Not yet recruiting
Riyadh, Saudi Arabia, 12746
King Fahad National Guard Hospital Not yet recruiting
Riyadh, Saudi Arabia, 14611
Spain
General University Hospital of Alicante Recruiting
Alicante, Spain, 03010
University Hospital Germans Trias i Pujol Recruiting
Badalona, Spain, 08916
University Hospital of the Canary Islands (HUC) La Laguna Recruiting
La Laguna, Spain, 38320
University Hospital de La Princesa Recruiting
Madrid, Spain, 28006
University Hospital La Paz Recruiting
Madrid, Spain, 28046
University Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
University Hospital Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Viladecans Hospital Recruiting
Viladecans, Spain, 08840
Switzerland
Lindenhofspital Recruiting
Bern, Switzerland, 3001
Cantonal Hospital Saint Gallen Recruiting
St.Gallen, Switzerland, 9007
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Taiwan
Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi Recruiting
Kozlu, Taiwan, 67000
Turkey
Ankara University Medical Faculty Cebeci Hospital Recruiting
Ankara, Turkey, 06590
Uludag Universitesi Tip Fakultesi Recruiting
Bursa, Turkey, 16059
Bezmialem Foundation University Medical Faculty Recruiting
Istanbul, Turkey, 34093
Marmara University Recruiting
Istanbul, Turkey, 34840
Kocaeli Derince Training and Research Hospital Recruiting
Kocaeli, Turkey, 41380
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi Recruiting
Trabzon, Turkey, 61080
Ukraine
Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases Recruiting
Dnipropetrovsk, Ukraine, 49074
Ivano-Frankivsk Central City Clinical Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76018
V.T. Zaitsev Institute of General and Emergency Surgery Recruiting
Kharkiv, Ukraine, 61018
Kyiv City Clinical Hospital #18 Not yet recruiting
Kyiv, Ukraine, 01030
Medical Center Consilium Medical Recruiting
Kyiv, Ukraine, 02000
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC Recruiting
Kyiv, Ukraine, 02175
Kyiv Regional Hospital #2 Recruiting
Kyiv, Ukraine, 04053
Kyiv Regional Clinical Hospital Recruiting
Kyiv, Ukraine, 04107
Volyn Regional Clinical Hospital Not yet recruiting
Lutsk, Ukraine, 43005
Public City Clinical Hospital of Emergency Medical Care Recruiting
Lviv, Ukraine, 79059
Ternopil City Public Emergency Medical Care Hospital Recruiting
Ternopil, Ukraine, 46008
Vinnytsia City Clinical Hospital #1 Recruiting
Vinnytsia, Ukraine, 02029
Vinnytsia M.I. Pyrohov Regional Clinical Hospital Recruiting
Vinnytsia, Ukraine, 21018
First Private Clinic Not yet recruiting
Zhytomyr, Ukraine, 10003
United Kingdom
Bristol Royal Infirmary Recruiting
Bristol, United Kingdom, BS2 8HW
Ulster Hospital Recruiting
Dundonald, United Kingdom, BT16 1RH
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Victoria Hospital Blackpool Recruiting
Lancashire Blackpool, United Kingdom, FY3 8NR
Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
John Radcliffe Hospital Not yet recruiting
Oxford, United Kingdom, OX3 9DU
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Torbay Hospital Recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Jerry Liu, MD Celgene Corporation

Additional Information:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03440372     History of Changes
Other Study ID Numbers: RPC01-3201
U1111-1203-7225 ( Registry Identifier: WHO )
2017-004292-31 ( EudraCT Number )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Crohn's Disease
Crohn Disease
Oral
Ozanimod
Moderately active
Severely active
RPC01
RPC01-3201
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases