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Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440385
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : November 26, 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

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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 #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 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 [ 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% [ 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 [ 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 to 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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): NCT03440385


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

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Kindred Medical Institute for Clinical Trials, LLC Not yet recruiting
Corona, California, United States, 92879
UCSD Medical Center Recruiting
La Jolla, California, United States, 92037
OM Research Recruiting
Lancaster, California, United States, 93534
Southern California Research Institute Medical Group, Inc. Recruiting
Los Angeles, California, United States, 90045
Matrix Clinical Research Inc Recruiting
Los Angeles, California, United States, 90048
Facey Medical Foundation (Parent) Recruiting
Mission Hills, California, United States, 91345
Havana Research Institute LLC Recruiting
Pasadena, California, United States, 91105
Sutter Medical Group Completed
Roseville, California, United States, 95661
UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit Not yet recruiting
Sacramento, California, United States, 95817
University of California at San Francisco Not yet recruiting
San Francisco, California, United States, 94158
New Hope Research Development Recruiting
West Covina, California, United States, 91790
United States, Colorado
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Connecticut Clinical Research Foundation Recruiting
Bristol, Connecticut, United States, 06010
United States, Florida
Clinical Reseach of West Florida Recruiting
Clearwater, Florida, United States, 33765
South Lake Pain Institute Recruiting
Clermont, Florida, United States, 34711
American Research Institute Inc Active, not recruiting
Cutler Bay, Florida, United States, 33157
Universal Axon Clinical Research Recruiting
Doral, Florida, United States, 33166
Riverside Clinical Research Recruiting
Edgewater, Florida, United States, 32132
SIH Research Recruiting
Kissimmee, Florida, United States, 34759
Precision Clinical Research, LLC. Recruiting
Lauderdale Lakes, Florida, United States, 33319
Alliance Medical Research LLC Recruiting
Lighthouse Point, Florida, United States, 33064
Center For Advanced Gastroenterology Recruiting
Maitland, Florida, United States, 32751
Galiz Research LLC Recruiting
Miami Springs, Florida, United States, 33166
LMG Research Recruiting
Miami, Florida, United States, 33125
Innovation Research Institute, Inc. Recruiting
Miami, Florida, United States, 33165
Life Medical Center & Research, Inc. Recruiting
Miami, Florida, United States, 33166
Bayside Clinical Research Recruiting
New Port Richey, Florida, United States, 34655
Omega Research Maitland, LLC Recruiting
Orlando, Florida, United States, 32810
IMIC, Inc. Recruiting
Palmetto Bay, Florida, United States, 33157
Theia Clinical Research, LLC Recruiting
Pinellas Park, Florida, United States, 33781
University of South Florida Recruiting
Tampa, Florida, United States, 33612-4799
Apex Clinical Research Completed
Tampa, Florida, United States, 33612
Guardian Angel Health Svcs Inc Recruiting
Tampa, Florida, United States, 33614
United States, Georgia
Children's Healthcare of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30322
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Atlanta Center For Gastroenterology, P.C. Recruiting
Decatur, Georgia, United States, 30030
United States, Idaho
Grand Teton Research Group, PLLC Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
MediSphere Medical Research Center, LLC Recruiting
Evansville, Indiana, United States, 47714
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cotton ONeil Clinical Research Center Digestive Health Recruiting
Topeka, Kansas, United States, 66606
United States, Louisiana
Gastroenterology Associates, LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Clinical Trials of SW Louisiana LLC Recruiting
Lake Charles, Louisiana, United States, 70601
Tandem Clinical Research, LLC Recruiting
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Harvard Medical School - Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Western Michigan University Homer Stryker M.D. School of Medicine Recruiting
Kalamazoo, Michigan, United States, 49008
Henry Ford Medical Center - New Center One Recruiting
Novi, Michigan, United States, 48377
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Mid America Gastrointestinal Consultants Recruiting
Kansas City, Missouri, United States, 64111
United States, Nevada
Internal Medicine Specialists Recruiting
Las Vegas, Nevada, United States, 89145
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Drug Trials America Recruiting
Hartsdale, New York, United States, 10530
Weill Cornell Medical College Completed
New York, New York, United States, 10010
Concorde Medical Group Recruiting
New York, New York, United States, 10016
TrialSpark Completed
New York, New York, United States, 10024
DiGiovanna Institute for Medical Education And Research Recruiting
North Massapequa, New York, United States, 11758-1802
United States, North Carolina
PMG Research of Charlotte LLC Recruiting
Charlotte, North Carolina, United States, 28209
PMG Research of Winston-Salem LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University Hospitals of Cleveland Not yet recruiting
Cleveland, Ohio, United States, 44106-5000
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Advance Clinical Research - Dayton Internal Medicine Recruiting
Dayton, Ohio, United States, 45417
Paramount Medical Research & Consulting, LLC Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Cancer Care Associates of OK-N PorterAvenue Recruiting
Norman, Oklahoma, United States, 73071
Allergy, Asthma and Immunology Center, PC Recruiting
Tulsa, Oklahoma, United States, 74136
Central States Research, LLC Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
University of Pennsylvania Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
San Antonio Military Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Centex Studies, Inc. Recruiting
Houston, Texas, United States, 77058
The Coastal Medical Group Recruiting
Houston, Texas, United States, 77089
Gulf Coast Research Group LLC Recruiting
Houston, Texas, United States, 77098
Accurate Clinical Research Inc Recruiting
Pasadena, Texas, United States, 77505
DHAT Research Institute Recruiting
Richardson, Texas, United States, 75082
San Antonio Gastroenterology Recruiting
San Antonio, Texas, United States, 78229
Baylor Scott and White Health Recruiting
Temple, Texas, United States, 76508
United States, Virginia
Blue Ridge Medical Research Recruiting
Lynchburg, Virginia, United States, 24502
The Gastroenterology Group Recruiting
Reston, Virginia, United States, 20191
McGuire Veterans Affairs Medical Center Recruiting
Richmond, Virginia, United States, 23249
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24016
United States, Wisconsin
Franciscan Skemp Healthcare Recruiting
La Crosse, Wisconsin, United States, 54601
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital and Hunter Medical Research Institute Recruiting
New Lambton Heights, New South Wales, Australia, 2305
Australia, Queensland
Coastal Digestive Health Recruiting
Maroorchydore, Queensland, Australia, 4558
University of the Sunshine Coast Completed
North Mackay, Queensland, Australia, 4740
Mater Hospital Brisbane Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Flinders Medical Centre Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Australia, Western Australia
St John of God Subiaco Hospital Recruiting
Subiaco, Western Australia, Australia, 6008
Austria
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
University Hospital St. Poelten Recruiting
St Polten, Austria, 3100
Medical University Vienna Recruiting
Vienna, Austria, 1090
Brazil
Hospital Sao Rafael Not yet recruiting
Salvador, Bahia, Brazil, 41253-190
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda Not yet recruiting
Goiania, Goiás, Brazil, 74535-170
Faculdade de Medicina de Botucatu Not yet recruiting
Botucatu, São Paulo, Brazil, 18618-970
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Not yet recruiting
Sao Jose do Rio Preto, São Paulo, Brazil, 15090
Instituto De Assistencia Medica Ao Servidor Publico Estadual - Iamspe - Hspe/Fmo Not yet recruiting
Sao Paulo, São Paulo, Brazil, 04038-034
Hospital Moinhos de Vento Not yet recruiting
Porto Alegre, Brazil, 90560-030
Faculdade de Medicina do ABC Not yet recruiting
Vila Sacadura Cabral, Brazil, 09060-870
CEDOES - Diagnostico e Pesquisa Not yet recruiting
Vitoria, Brazil, 29055-450
Bulgaria
MHAT Ruse AD Recruiting
Ruse, Bulgaria, 7002
Excelsior Medical Center Recruiting
Sofia, Bulgaria, 1407
Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia Recruiting
Sofia, Bulgaria, 1407
Diagnostic and Consulting Center Alexandrovska Recruiting
Sofia, Bulgaria, 1431
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD Recruiting
Sofia, Bulgaria, 1527
Diagnostic-Consultative Center Sveta Anna Not yet recruiting
Sofia, Bulgaria, 1709
Canada, Alberta
West Edmonton Gastroenterology Consultants Not yet recruiting
Edmonton, Alberta, Canada, T5R1W2
Canada, British Columbia
Fraser Clinical Trials Inc. Recruiting
New Westminister, British Columbia, Canada, V3L 3W5
GI Research Institute Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Manitoba
Brandon Medical Arts Clinic Recruiting
Brandon, Manitoba, Canada, R7A 0N7
Canada, Nova Scotia
IWK Health Center Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Dr.Garisa Jagan Mohan Reddy MD Recruiting
Sudbury, Ontario, Canada, P3C 5K6
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Kensington Screening Clinic Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
The Ottawa Hospital - General Campus Recruiting
Ottawa, Quebec, Canada, K1H 8L6
China
Peking University First Hospital Not yet recruiting
Beijing, China, 100034
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University Not yet recruiting
Beijing, China, 100050
First Hospital of Jilin University Not yet recruiting
Changchun, China, 130021
Xiangya Hospital of Central South University Not yet recruiting
Changsha, China, 410008
Daping Hospital Third Military Medical University of People's Liberation Army Not yet recruiting
Chongqing, China, 630042
PLA Army General Hospital Not yet recruiting
Dongcheng District, China, 100700
Guangzhou First People's Hospital Not yet recruiting
Guangzhou Shi, China, 510180
Sun Yat-sen University - The Sixth Affiliated Hospital Not yet recruiting
Guangzhou Shi, China, 510655
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510030
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangzhou, China, 510515
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 100142
The Second Affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, China, 310009
The First Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, China, 330006
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, China, 210029
Shanghai City theTenth People's Hospital Not yet recruiting
Shanghai City, China, 200072
Ruijin Hospital Shanghai Jiaotong University Not yet recruiting
Shanghai, China, 200025
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, China, 200127
China Medical University Hospital Recruiting
Taichung City, China, 40447
RenMin Hospital Of Wuhan University Hubei General Hospital Not yet recruiting
Wuhan Shi, China, 430060
Wuhan Union Hospital Not yet recruiting
Wuhan, China, 430022
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Not yet recruiting
Wuhan, China, 430030
Zhangzhou Municipal Hospital of Fujian Province Not yet recruiting
Zhangzhou, China, 363000
Finland
Helsinki University Central Hospital (HUCH) Recruiting
Helsinki, Finland, 00290
Turku University Hospital Recruiting
Turku, Finland, FI-20520
Georgia
JSC Evex Medical Corporation - Batumi Referral Hospital Recruiting
Batumi, Georgia, 6010
JSC Evex Medical Corporation - Oncology Center Recruiting
Kutaisi, Georgia, 4600
LLC Vivamedi Recruiting
Tbilisi, Georgia, 0131
Tbilisi State Medical University Not yet recruiting
Tbilisi, Georgia, 0141
LTD Institute of Clinical Cardiology Recruiting
Tbilisi, Georgia, 0159
JSC Infectious Disease, AIDS and Clinical Immunology Research Center Recruiting
Tbilisi, Georgia, 0160
LTD Academician N.Kipshidze Central University Clinic Recruiting
Tbilisi, Georgia, 0160
LTD Aversi Clinic Recruiting
Tbilisi, Georgia, 0160
LTD MediClub Georgia Recruiting
Tbilisi, Georgia, 0160
David Tatishvili Medical Center Recruiting
Tbilisi, Georgia, 0186
JSC Evex Medical Corporation - Telavi Referral Hospital Recruiting
Telavi, Georgia, 2200
Germany
Gastroenterological Special Practice at Wittenbergplatz Recruiting
Berlin, Germany, 10787
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Charite - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Hospital Waldfriede e.V. Recruiting
Berlin, Germany, 14163
Brandenburg City Hospital Recruiting
Brandenburg an der Havel, Germany, 14770
Medical Care Unit Dachau Recruiting
Dachau, Germany, 85221
Klinikum Darmstadt Not yet recruiting
Darmstadt, Germany, 64283
Kliniken Essen-Mitte Not yet recruiting
Essen, Germany, 45136
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt am Main, Germany, 60590
Studiengesellschaft BSF Recruiting
Halle, Germany, 06108
University Hospital Halle (Saale) Recruiting
Halle, Germany, 06120
Asklepios Klinik Hamburg Completed
Hamburg, Germany, 22559
Universitatsklinikum Schleswig-Holstein Recruiting
Keil, Germany, 24105
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Recruiting
Mainz, Germany, 55131
University Hospital Muenster Recruiting
Muenster, Germany, 48149
Robert-Bosch-Hospital Not yet recruiting
Stuttgart, Germany, 70376
Greece
Laiko General Hospital of Athens Recruiting
Athens, Greece, 11 527
Sotiria Chest Diseases Hospital of Athens Recruiting
Athens, Greece, 11527
Tzanio General Hospital of Piraeus Recruiting
Athens, Greece, 18536
PAGNI University Hospital Recruiting
Heraklion, Greece, 71 110
General Hospital of Thessaloniki Hippokration Recruiting
Thessaloniki, Greece, 54642
424th Army General Hospital Recruiting
Thessaloniki, Greece, 56429
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Magyar Honvedseg Egeszsegugyi Kozpont Recruiting
Budapest, Hungary, 1062
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar Recruiting
Budapest, Hungary, 1088
Szent Margit Korhaz Not yet recruiting
Budapest, Hungary, H-1032
Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat Recruiting
Gyor, Hungary, 9024
CRU Hungary Kft Recruiting
Miskolc, Hungary, 3529
Kanizsai Dorottya Hospital Recruiting
Nagykanizsa, Hungary, H-8800
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Recruiting
Szekesfehervar, Hungary, 8000
Clinfan Ltd Recruiting
Szekszárd, Hungary, 7100
Csongrad County Dr. Bugyi Istvan Hospital Recruiting
Szentes, Hungary, 6600
Zala Megyei KorhazHaematologia Not yet recruiting
Zalaegerszeg, Hungary, 8900
Israel
Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center Recruiting
Afula, Israel, 18341
Asaf Harofeh Medical Center Recruiting
Beer Jacob, Israel, 73100
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Clalit Health Services Recruiting
Jerusalem, Israel, 9362410
Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 612-030
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-030
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 3080
St. Vincent's Hospital Recruiting
Suwon, Korea, Republic of, 442723
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Recruiting
Kaunas, Lithuania, LT-50009
Klaipeda University Hospital Recruiting
Klaipeda, Lithuania, LT-5808
Vilnius University Hospital Santariskes Clinics Recruiting
Vilnius, Lithuania, 08406
Vilnius University Hospital Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Vilnius City Clinical Hospital Recruiting
Vilnius, Lithuania, LT-10207
Netherlands
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
UMC Groningen Recruiting
Groningen, Netherlands, 9713 GZ
University Hospital Maastricht Not yet recruiting
Maastricht, Netherlands, 6229 HX
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525 GA
Zuyderland Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6162 BG
St. Elisabeth Ziekenhuis Recruiting
Tilburg, Netherlands, 5022 GC
Poland
St. John Paul 2nd Municipal Hospital in Elblag Recruiting
Elblag, Poland, 82-300
Private Medical Practice Miroslaw Fic Recruiting
Jelenia Gora, Poland, 58-500
BioVirtus Medical Centre Recruiting
Jozefow, Poland, 05-410
LUX MED Centrum Medyczne - Krakow Not yet recruiting
Krakow, Poland, 30-392
Centrum Opieki Zdrowotnej Orkan Med Recruiting
Ksawerow, Poland, 95-054
LUX MED Centrum Medyczne - Lodz Recruiting
Lodz, Poland, 93-034
Non-Public Healthcare Facility Allmedica Clinical Trials Recruiting
Nowy Targ, Poland, 34-400
Endoskopia Sp. z o.o. Recruiting
Sopot, Poland, 81-756
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC Recruiting
Szczecin, Poland, 71-270
PRIMA LCC Specialist Clinics Recruiting
Warsaw, Poland, 02-018
Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1 Recruiting
Warszawa, Poland, 02-653
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice Recruiting
Wierzchoslawice, Poland, 33-122
LUX MED Centrum Medyczne - Wroclaw Recruiting
Wroclaw, Poland, 50-053
Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-367
Clinical Research Center Early-Phase Research Facility Recruiting
Wroclaw, Poland, 51-162
LexMedica Recruiting
Wroclaw, Poland, 53-114
Ars Medica Recruiting
Wroclaw, Poland, 53-333
EMC Medical Institute S.A Recruiting
Wroclaw, Poland, 54-144
Portugal
Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra Recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes Recruiting
Guimaraes, Portugal, 4835-044
Hospital Beatriz Angelo Not yet recruiting
Loures, Portugal, 2674-514
Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE Recruiting
Viana do Castelo, Portugal, 4904-858
Russian Federation
Joint Venture Company Diagnostic Center, Bioterm Ltd. Recruiting
Barnaul, Russian Federation, 656015
Territorial Clinical Hospital Recruiting
Barnaul, Russian Federation, 656024
Regional Clinical Hospital #3 Recruiting
Chelyabinsk, Russian Federation, 454021
Chelyabinsk Regional Clinical Hospital Recruiting
Chelyabinsk, Russian Federation, 454076
Ural State Medical Academy - Medical Association Novaya Bolnitsa Not yet recruiting
Ekaterinburg, Russian Federation, 620109
Immanuel Kant Baltic Federal University Recruiting
Kaliningrad, Russian Federation, 236016
Kaluga Regional Hospital Recruiting
Kaluga, Russian Federation, 248007
S.V. Beliaev Kemerovo Regional Clinical Hospital Recruiting
Kemerovo, Russian Federation, 650066
City Clinical Hospital n.a. V.M. Buyanov Recruiting
Moscow, Russian Federation, 115516
City Clinical Hospital 24 Recruiting
Moscow, Russian Federation, 117997
CJSC Nasledniki Recruiting
Moscow, Russian Federation, 119192
A.N. Ryzhikh State Research Center for Coloproctology Recruiting
Moscow, Russian Federation, 123423
Railway Station Clinical Hospital Recruiting
Nizhny Novgorod, Russian Federation, 603140
Medical Center Sibnovomed LLC Recruiting
Novosibirsk, Russian Federation, 630091
Scientific Research Institute of Physiology and Basic Medicine Recruiting
Novosibirsk, Russian Federation, 630117
Euromed Multi-Specialty Center for Contemporary Medicine LLC Recruiting
Omsk, Russian Federation, 644024
Medical Diagnostic Center LLC Recruiting
Orenburg, Russian Federation, 460050
N.N. Burdenko Penza Regional Clinical Hospital Not yet recruiting
Penza, Russian Federation, 440026
City Clinical Hospital No 31 - St. Petersburg Recruiting
Saint Petersburg, Russian Federation, 197110
S.M. Kirov Military Medical Academy Recruiting
Saint-Petersburg, Russian Federation, 194044
Medical University REAVIZ Recruiting
Samara, Russian Federation, 443001
Regional Clinical Hospital Recruiting
Saratov, Russian Federation, 410053
Sochi City Hospital No 5 Recruiting
Sochi, Russian Federation, 354207
Oncology Center of Moskovskiy District Recruiting
St Petersburg, Russian Federation, 196247
City Outpatient Care Unit No 38 Recruiting
St. Petersburg, Russian Federation, 191015
I.I. Mechnikov North-Western State Medical University Recruiting
St. Petersburg, Russian Federation, 191015
State Unitary Enterprise Passengeravtotrans Recruiting
St. Petersburg, Russian Federation, 195009
Medical Center ItanoMed Not yet recruiting
St. Petersburg, Russian Federation, 196128
Medical Center Eko-Bezopasnost LLC Recruiting
St. Petersburg, Russian Federation, 196143
Tomsk Regional Clinical Hospital Recruiting
Tomsk, Russian Federation, 634063
G.G. Kuvatov Republican Clinical Hospital Recruiting
Ufa, Russian Federation, 450005
Medical Scientific Manufacturing Association Dvizheniye Clinic Recruiting
Volgograd, Russian Federation, 400107
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine Recruiting
Belgrade, Serbia, 11 080
Clinical Hospital Center Zvezdara Clinic of Internal Diseases Recruiting
Belgrade, Serbia, 11000
Military Medical Academy, Clinic of Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, 11000
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology Recruiting
Novi Sad, Serbia, 21 000
General Hospital Pancevo Recruiting
Pancevo, Serbia, 26000
General Hospital Djordje Jovanovic Zrenjanin Recruiting
Zrenjanin, Serbia, 23 000
Slovakia
Cliniq, s.r.o. Recruiting
Bratislava, Slovakia, 820 07
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Recruiting
Bratislava, Slovakia, 82606
Brezno gastroenterology center s.r.o. Completed
Brezno, Slovakia, 97701
KM Management, spol. s r.o. Recruiting
Nitra, Slovakia, 94901
Gastromedic s.r.o. Recruiting
Nove Zamky, Slovakia, 94002
GASTRO I., s.r.o. Recruiting
Presov, Slovakia, 080 01
World of the Health Inc. General Hospital Rimavska Sobota Recruiting
Rimavska Sobota, Slovakia, 979 01
Slovenia
General Hospital Celje Recruiting
Celje, Slovenia, 3000
General Hospital Novo Mesto Not yet recruiting
Novo Mesto, Slovenia, 8000
South Africa
Ahmed Kathrada Private Hospital Recruiting
Gauteng, South Africa, 1820
Emmed Research Recruiting
Pretoria, South Africa, 0084
Spain
Teknon Medical Center Recruiting
Barcelona, Spain, 08022
University Hospital Reina Sofia Recruiting
Cordoba, Spain, 14001
University Hospital of Girona Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Hospital Universitario de Gran Canaria Dr. Negrin Recruiting
Las Palmas de Gran Canaria, Spain, 35012
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
University Hospital Puerta de Hierro Majadajonda Recruiting
Majadahonda, Madrid, Spain, 28222
University Hospital Marques de Valdecilla (HUMV) Recruiting
Santander, Spain, 39008
University Clinical Hospital of Valencia Recruiting
Valencia, Spain, 46010
University Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Sweden
Saint Goran Hospital Recruiting
Stockholm, Sweden, 112 81
Ersta Hospital Not yet recruiting
Stockholm, Sweden, 116 91
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, San Ming Dist., Taiwan, 807
E-DA Hospital Recruiting
Kaohsiung, Taiwan, 82445
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital Recruiting
Niao-Sung Hsiang Kaohsiung County, Taiwan, 83301
National Cheng Kung University Hospital Recruiting
Tainan, Taiana, Taiwan, 704
Chang Gung Memorial Hospital- Linkou Recruiting
Taoyuan City, Taiwan, 33305
Taipei Veterans General Hospital Completed
Tapei, Beitou Dist., Taiwan, 11217
National Taiwan University Hospital Recruiting
Tapei, Taiwan, 10002
Turkey
Hacettepe Universitesi Recruiting
Ankara, Turkey, 01660
Firat University Medical Faculty Recruiting
Elazig, Turkey, 23119
Istanbul University Cerrahpasa Medical Faculty Recruiting
Istanbul, Turkey, 34098
Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi Recruiting
Istanbul, Turkey, 34668
Istanbul Medeniyet Uni Goztepe Training&Res Hosp Recruiting
Istanbul, Turkey, 34854
Ukraine
Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2 Not yet recruiting
Dnipropetrovsk, Ukraine, 49027
Ivano-Frankivsk Regional Clinical Hospital Recruiting
Ivano-Frankivsk, Ukraine, 76008
Kharkiv City Clinical Hospital 2 Recruiting
Kharkiv, Ukraine, 61037
Khmelnytskyi Regional Hospital Recruiting
Khmelnytskyi, Ukraine, 29000
Medical and Diagnostic Center Acinus Recruiting
Kropyvnytskyi, Ukraine, 25006
Medical Center Medical Clinic Blagomed LLC Not yet recruiting
Kyiv, Ukraine, 01023
Kyiv City Clinical Hospital #18 Not yet recruiting
Kyiv, Ukraine, 01030
BIK-KYIV Ukrainian German Gastroenterology Center Recruiting
Kyiv, Ukraine, 01601
Kyiv Regional Clinical Hospital Recruiting
Kyiv, Ukraine, 04107
Lviv Regional Clinical Hospital Recruiting
Lviv, Ukraine, 79010
Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department Recruiting
Odesa, Ukraine, 65025
Vinnytsia M.I. Pyrohov Regional Clinical Hospital Recruiting
Vinnytsia, Ukraine, 21018
Health Clinic, LLC Recruiting
Vinnytsya, Ukraine, 21009
Zaporizhzhya Regional Recruiting
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Kanthi Kollengode, MD Celgene Corporation

Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03440385    
Other Study ID Numbers: RPC01-3202
U1111-1203-7949 ( Registry Identifier: WHO )
2017-004293-33 ( EudraCT Number )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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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
RPC01-3202
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases