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

NCT ID: NCT03440372

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 625 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2024-10-01

Brief Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Administration of oral Ozanimod

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

Specified dose on specified days

Administration of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Specified dose on specified days

Interventions

Ozanimod

Specified dose on specified days

Intervention Type: DRUG

Placebo

Specified dose on specified days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria

• Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
• Current stoma, ileal-anal pouch anastomosis, or fistula

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Holland Center for Family Health

Peoria, Arizona, United States

Local Institution - 026

North Little Rock, Arkansas, United States

Local Institution - 284

Camarillo, California, United States

Local Institution - 165

Chula Vista, California, United States

Local Institution - 039

Garden Grove, California, United States

San Diego Clinical Trials

La Mesa, California, United States

Local Institution - 061

Los Angeles, California, United States

Local Institution - 110

Los Angeles, California, United States

Local Institution - 140

Mission Viejo, California, United States

Alliance Clinical Research

Oceanside, California, United States

Local Institution - 027

Orange, California, United States

Palo Alto Center-Palo Alto Medical Foundation Research Institute

Palo Alto, California, United States

Local Institution - 006

Rialto, California, United States

Local Institution - 003

San Diego, California, United States

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Lakewood, Colorado, United States

Local Institution - 225

Bristol, Connecticut, United States

Local Institution - 091

New Haven, Connecticut, United States

Local Institution - 062

Clearwater, Florida, United States

Local Institution - 218

Gainesville, Florida, United States

Local Institution - 203

Hialeah, Florida, United States

Harmony Medical Research Institute

Hialeah, Florida, United States

Local Institution - 078

Hialeah, Florida, United States

Local Institution - 179

Hollywood, Florida, United States

Local Institution - 101

Homestead, Florida, United States

Local Institution - 016

Largo, Florida, United States

Local Institution - 199

Miami, Florida, United States

LCC Medical Research Institute, LLC

Miami, Florida, United States

Local Institution - 169

Miami, Florida, United States

Local Institution - 090

Naples, Florida, United States

Local Institution - 214

New Smyrna Beach, Florida, United States

Local Institution - 076

Orlando, Florida, United States

Local Institution - 098

Port Orange, Florida, United States

Local Institution - 226

Tampa, Florida, United States

Local Institution - 149

Tampa, Florida, United States

Local Institution - 114

Weeki Wachee, Florida, United States

Local Institution - 205

Atlanta, Georgia, United States

Local Institution - 222

Atlanta, Georgia, United States

Local Institution - 019

Atlanta, Georgia, United States

Local Institution - 063

Atlanta, Georgia, United States

Local Institution - 074

Columbus, Georgia, United States

Local Institution - 028

Macon, Georgia, United States

Local Institution - 194

Chicago, Illinois, United States

Local Institution - 036

Chicago, Illinois, United States

Local Institution - 146

Urbana, Illinois, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

Local Institution - 155

Lexington, Kentucky, United States

CroNOLA LLC

Houma, Louisiana, United States

Local Institution - 053

Lake Charles, Louisiana, United States

Local Institution - 104

New Orleans, Louisiana, United States

Local Institution - 278

Baltimore, Maryland, United States

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Catonsville, Maryland, United States

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Glen Burnie, Maryland, United States

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Chestnut Hill, Massachusetts, United States

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North Worcester, Massachusetts, United States

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Springfield, Massachusetts, United States

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Caro, Michigan, United States

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Southfield, Michigan, United States

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Wyoming, Michigan, United States

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Ypsilanti, Michigan, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Englewood, New Jersey, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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New York, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

Advantage Clinical Trials

The Bronx, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Mentor, Ohio, United States

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Warren, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

Penn State University Milton S Hershey Medical Center

State College, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Advanced Gastroenterology

Union City, Tennessee, United States

Local Institution - 158

Austin, Texas, United States

Local Institution - 056

Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Southlake, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Gainesville, Virginia, United States

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Manassas, Virginia, United States

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Petersburg, Virginia, United States

Virginia Gastroenterology Institute PC

Suffolk, Virginia, United States

Local Institution - 296

Williamsburg, Virginia, United States

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Spokane, Washington, United States

Aurora Health Care Aurora Research

Grafton, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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San Miguel de Tucumán, , Argentina

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Melbourne, Victoria, Australia

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Murdoch, Western Australia, Australia

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Bankstown, , Australia

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Box Hill, , Australia

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Sydney, NSW, , Australia

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Grodno, , Belarus

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Brasschaat, Antwerpen, Belgium

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Brussels, , Belgium

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Seraing, , Belgium

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Tournai, , Belgium

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Banja Luka, , Bosnia and Herzegovina

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Blagoevgrad, , Bulgaria

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Osijek, , Croatia

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Split, , Croatia

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Zagreb, , Croatia

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Brno, , Czechia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Most, , Czechia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Copenhagen, , Denmark

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Holbæk, , Denmark

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Nykøbing Falster, , Denmark

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Turku, , Finland

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Amiens, , France

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Lillie Cedex, , France

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Marseille, , France

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Montpellier, , France

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Rennes, , France

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Rouen, , France

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Toulouse, , France

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Tbilisi, , Georgia

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Berlin, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Ludwigshafen am Rhein, , Germany

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Stuttgart, , Germany

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Ulm, , Germany

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Castellana Grotte, , Italy

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Roma, , Italy

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Rome, , Italy

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Udine, , Italy

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Varese, , Italy

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Verona, , Italy

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Riga, , Latvia

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Riga, , Latvia

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Zapapan, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Querétaro City, Querétaro, Mexico

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Chihuahua City, , Mexico

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México, , Mexico

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Tlalpan, , Mexico

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Chisinau, , Moldova

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Chisinau, , Moldova

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Chisinau, , Moldova

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Chisinau, , Moldova

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Chisinau, , Moldova

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Zamość, Lublin Voivodeship, Poland

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Zamość, Lublin Voivodeship, Poland

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Bialystok, , Poland

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Bochnia, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Kłodzko, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Opole, , Poland

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Oświęcim, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Sopot, , Poland

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Szczecin, , Poland

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Ul. Piotrkowska 177, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Târgu Mureş, , Romania

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Chita, , Russia

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Irkutsk, , Russia

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Samara, , Russia

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Ufa, , Russia

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Veliky Novgorod, , Russia

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Vladimir, , Russia

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Vladivostok, , Russia

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Vladivostok, , Russia

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Dammam, , Saudi Arabia

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Jeddah, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Ansan, , South Korea

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Busan, , South Korea

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Guri-si, , South Korea

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Seoul, , South Korea

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Alicante, , Spain

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San Cristóbal de La Laguna, , Spain

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Seville, , Spain

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Bern, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Kozlu, , Taiwan

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Ankara, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmit/Kocaeli, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Chernivtsi, , Ukraine

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Dnipropetrovsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Lviv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Ternopil, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Southampton, Hampshire, United Kingdom

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London, LND, United Kingdom

Local Institution - 557

Birmingham, , United Kingdom

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Bristol, , United Kingdom

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Cardiff, , United Kingdom

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Chorley, , United Kingdom

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Corbridge Road, , United Kingdom

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Dundonald, , United Kingdom

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Glasgow, , United Kingdom

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Lancashire Blackpool, , United Kingdom

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London, , United Kingdom

Local Institution - 715

London, , United Kingdom

Local Institution - 561

North Manchester Science Park, , United Kingdom

Local Institution - 593

Shrewsbury, , United Kingdom

Local Institution - 718

Torquay, , United Kingdom

Countries

United States; Argentina; Australia; Belarus; Belgium; Bosnia and Herzegovina; Bulgaria; Canada; Chile; Croatia; Czechia; Denmark; Finland; France; Georgia; Germany; India; Ireland; Israel; Italy; Latvia; Mexico; Moldova; Poland; Romania; Russia; Saudi Arabia; Serbia; South Korea; Spain; Switzerland; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36208720 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

U1111-1203-7225

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-004292-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RPC01-3201

Identifier Type: -

Identifier Source: org_study_id