TerminatedPhase 3
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Reason given: Business objectives have changed.
Key facts
- Where
- Asheville, Atlanta, Austin, Baltimore, Beachwood, Bristol, Brooklyn, Camarillo, Caro, Catonsville, Charleston, Charlotte, Chestnut Hill, Chicago, Chula Vista, Cincinnati, Clearwater, Cleveland, Clive, Columbus, Englewood, Gainesville, Garden Grove, Glen Burnie, Grafton, Great Neck, Greenville, Hershey, Hialeah, Hollywood, Homestead, Houma, Houston, Jackson, La Mesa, Lake Charles, Lakewood, Largo, Lexington, Los Angeles, Macon, Manassas, Mentor, Miami, Mission Viejo, Naples, Nashville, New Haven, New Orleans, New Smyrna Beach, New York, North Little Rock, North Worcester, Oceanside, Oklahoma City, Orange, Orchard Park, Orlando, Palo Alto, Peoria, Petersburg, Port Orange, Portland, Providence, Raleigh, Rialto, Salt Lake City, San Antonio, San Diego, Southfield, Southlake, Spokane, Springfield, St Louis, State College, Suffolk, Tampa, The Bronx, Tyler, Union City, Urbana, Warren, Weeki Wachee, Williamsburg, Wyoming, and Ypsilanti, United StatesSee the 107 sites
- Phase
- Phase 3
Where in United States
- AshevilleAsheville, United StatesNo longer taking part
- AtlantaAtlanta, United StatesNo longer taking part
- AtlantaAtlanta, United StatesNo longer taking part
- AtlantaAtlanta, United StatesNo longer taking part
- AtlantaAtlanta, United StatesNo longer taking part
- AustinAustin, United StatesNo longer taking part
- BaltimoreBaltimore, United StatesNo longer taking part
- BeachwoodBeachwood, United StatesNo longer taking part
- BristolBristol, United StatesNo longer taking part
- BrooklynBrooklyn, United StatesNo longer taking part
- CamarilloCamarillo, United StatesNo longer taking part
- CaroCaro, United StatesNo longer taking part
- CatonsvilleCatonsville, United StatesNo longer taking part
- CharlestonCharleston, United StatesNo longer taking part
- CharlotteCharlotte, United StatesNo longer taking part
- CharlotteCharlotte, United StatesNo longer taking part
- Chestnut HillChestnut Hill, United StatesNo longer taking part
- ChicagoChicago, United StatesNo longer taking part
- ChicagoChicago, United StatesNo longer taking part
- Chula VistaChula Vista, United StatesNo longer taking part
- CincinnatiCincinnati, United StatesNo longer taking part
- ClearwaterClearwater, United StatesNo longer taking part
- ClevelandCleveland, United StatesNo longer taking part
- Iowa Digestive Disease CenterClive, United StatesNo longer taking part
- ColumbusColumbus, United StatesNo longer taking part
- EnglewoodEnglewood, United StatesNo longer taking part
- GainesvilleGainesville, United StatesNo longer taking part
- GainesvilleGainesville, United StatesNo longer taking part
- Garden GroveGarden Grove, United StatesNo longer taking part
- Glen BurnieGlen Burnie, United StatesNo longer taking part
- Aurora Health Care Aurora ResearchGrafton, United StatesNo longer taking part
- Great NeckGreat Neck, United StatesNo longer taking part
- GreenvilleGreenville, United StatesNo longer taking part
- HersheyHershey, United StatesNo longer taking part
- HialeahHialeah, United StatesNo longer taking part
- HialeahHialeah, United StatesNo longer taking part
- Harmony Medical Research InstituteHialeah, United StatesNo longer taking part
- HollywoodHollywood, United StatesNo longer taking part
- HomesteadHomestead, United StatesNo longer taking part
- CroNola LLCHouma, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- JacksonJackson, United StatesNo longer taking part
- San Diego Clinical TrialsLa Mesa, United StatesNo longer taking part
- Lake CharlesLake Charles, United StatesNo longer taking part
- LakewoodLakewood, United StatesNo longer taking part
- LargoLargo, United StatesNo longer taking part
- LexingtonLexington, United StatesNo longer taking part
- Los AngelesLos Angeles, United StatesNo longer taking part
- Los AngelesLos Angeles, United StatesNo longer taking part
- MaconMacon, United StatesNo longer taking part
- ManassasManassas, United StatesNo longer taking part
- MentorMentor, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- LCC Medical Research Institute, LLCMiami, United StatesNo longer taking part
- Mission ViejoMission Viejo, United StatesNo longer taking part
- NaplesNaples, United StatesNo longer taking part
- NashvilleNashville, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- New HavenNew Haven, United StatesNo longer taking part
- New OrleansNew Orleans, United StatesNo longer taking part
- New Smyrna BeachNew Smyrna Beach, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- North Little RockNorth Little Rock, United StatesNo longer taking part
- North WorcesterNorth Worcester, United StatesNo longer taking part
- Alliance Clinical ResearchOceanside, United StatesNo longer taking part
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- OrangeOrange, United StatesNo longer taking part
- Orchard ParkOrchard Park, United StatesNo longer taking part
- OrlandoOrlando, United StatesNo longer taking part
- Palo Alto Center-Palo Alto Medical Foundation Research InstitutePalo Alto, United StatesNo longer taking part
- Holland Center for Family HealthPeoria, United StatesNo longer taking part
- PetersburgPetersburg, United StatesNo longer taking part
- Port OrangePort Orange, United StatesNo longer taking part
- PortlandPortland, United StatesNo longer taking part
- ProvidenceProvidence, United StatesNo longer taking part
- RaleighRaleigh, United StatesNo longer taking part
- RialtoRialto, United StatesNo longer taking part
- Salt Lake CitySalt Lake City, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
- San DiegoSan Diego, United StatesNo longer taking part
- SouthfieldSouthfield, United StatesNo longer taking part
- SouthlakeSouthlake, United StatesNo longer taking part
- SpokaneSpokane, United StatesNo longer taking part
- SpringfieldSpringfield, United StatesNo longer taking part
- St LouisSt Louis, United StatesNo longer taking part
- Penn State University Milton S Hershey Medical CenterState College, United StatesNo longer taking part
- Virginia Gastroenterology Institute PCSuffolk, United StatesNo longer taking part
- TampaTampa, United StatesNo longer taking part
- TampaTampa, United StatesNo longer taking part
- Advantage Clinical TrialsThe Bronx, United StatesNo longer taking part
- TylerTyler, United StatesNo longer taking part
- Advanced GastroenterologyUnion City, United StatesNo longer taking part
- UrbanaUrbana, United StatesNo longer taking part
- WarrenWarren, United StatesNo longer taking part
- Weeki WacheeWeeki Wachee, United StatesNo longer taking part
- WilliamsburgWilliamsburg, United StatesNo longer taking part
- WyomingWyoming, United StatesNo longer taking part
- YpsilantiYpsilanti, United StatesNo longer taking part
Trial details
- Who runs it
- Celgene
- Trial code
- NCT03440372
- Record updated
- 4 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Other protocol-defined inclusion/exclusion criteria apply.