---
title: "Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease"
nct_id: NCT03440385
overall_status: COMPLETED
phase: PHASE3
sponsor: Celgene
study_type: INTERVENTIONAL
primary_condition: Crohn Disease
countries: United States, Australia, Austria, Bulgaria, Canada, China, Colombia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Israel, Lithuania, Netherlands, Poland, Portugal, Russia, Senegal, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03440385.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03440385"
ct_last_update_post_date: 2024-12-05
last_seen_at: "2026-05-12T07:34:05.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

**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

**NCT ID:** [NCT03440385](https://clinicaltrials.gov/study/NCT03440385)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 606
- **Lead Sponsor:** Celgene
- **Conditions:** Crohn Disease
- **Start Date:** 2018-03-07
- **Completion Date:** 2023-11-21
- **CT.gov Last Update:** 2024-12-05

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

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

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 therapy
* Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
* Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
* Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
* 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
```

## Arms

- **Administration of oral Ozanimod** (EXPERIMENTAL)
- **Administration of Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Ozanimod** (DRUG) — Specified dose on specified days
- **Placebo** (OTHER) — Specified dose on specified days

## Primary Outcomes

- **Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150** _(time frame: Week 12)_ — The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

## Secondary Outcomes

- **Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission** _(time frame: Week 12)_
- **Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%** _(time frame: Week 12)_
- **Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150** _(time frame: Week 12)_
- **Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%** _(time frame: Week 12)_
- **Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%** _(time frame: Week 12)_
- **Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points** _(time frame: Week 12)_
- **Percentage of Participants With Global Histologic Activity Score (GHAS) Remission** _(time frame: Week 12)_
- **Percentage of Participants With CDAI Reduction From Baseline of >=70 Points** _(time frame: Week 12)_
- **Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%** _(time frame: Week 12)_
- **Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%** _(time frame: Week 12)_
- **Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response** _(time frame: Week 12)_
- **Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12** _(time frame: Week 12)_

## Locations (368)

- Local Institution - 202, Scottsdale, Arizona, United States
- Ucsd Medical Center, La Jolla, California, United States
- Local Institution - 010, Lancaster, California, United States
- Southern California Research Institute Medical Group, Inc., Los Angeles, California, United States
- Matrix Clinical Research Inc, Los Angeles, California, United States
- Facey Medical Foundation (Parent), Mission Hills, California, United States
- Local Institution - 093, Pasadena, California, United States
- Sutter Medical Group, Roseville, California, United States
- Local Institution - 280, Sacramento, California, United States
- Local Institution - 281, San Francisco, California, United States
- Local Institution - 124, West Covina, California, United States
- Local Institution - 065, Colorado Springs, Colorado, United States
- Local Institution - 182, Bristol, Connecticut, United States
- Local Institution - 166, Clearwater, Florida, United States
- Local Institution - 084, Clermont, Florida, United States
- American Research Institute Inc, Cutler Bay, Florida, United States
- Local Institution - 112, Doral, Florida, United States
- Riverside Clinical Research, Edgewater, Florida, United States
- SIH Research, Kissimmee, Florida, United States
- Local Institution - 067, Lighthouse PT, Florida, United States
- Center For Advanced Gastroenterology, Maitland, Florida, United States
- LMG Research, Miami, Florida, United States
- Local Institution - 175, Miami, Florida, United States
- Local Institution - 081, Miami, Florida, United States
- Local Institution - 044, Miami Springs, Florida, United States
- Local Institution - 192, New Port Richey, Florida, United States
- Local Institution - 200, Orlando, Florida, United States
- Local Institution - 002, Palmetto Bay, Florida, United States
- Theia Clinical Research, LLC, Pinellas Park, Florida, United States
- Precision Clinical Research, LLC., Sunrise, Florida, United States
- Local Institution - 183, Tampa, Florida, United States
- Apex Clinical Research, Tampa, Florida, United States
- Local Institution - 107, Tampa, Florida, United States
- Local Institution - 037, Atlanta, Georgia, United States
- Local Institution - 220, Atlanta, Georgia, United States
- Local Institution - 143, Decatur, Georgia, United States
- Local Institution - 115, Idaho Falls, Idaho, United States
- Local Institution - 022, Chicago, Illinois, United States
- Local Institution - 092, Evansville, Indiana, United States
- Local Institution - 033, Indianapolis, Indiana, United States
- Local Institution - 070, Topeka, Kansas, United States
- Local Institution - 020, Baton Rouge, Louisiana, United States
- Clinical Trials of SW Louisiana LLC, Lake Charles, Louisiana, United States
- Tandem Clinical Research, LLC, Marrero, Louisiana, United States
- Local Institution - 024, Worcester, Massachusetts, United States
- Local Institution - 167, Kalamazoo, Michigan, United States
- Local Institution - 005, Novi, Michigan, United States
- Local Institution - 095, Minneapolis, Minnesota, United States
- Local Institution - 045, Rochester, Minnesota, United States
- Local Institution - 198, Kansas City, Missouri, United States
- Internal Medicine Specialists, Las Vegas, Nevada, United States
- Local Institution - 040, Lebanon, New Hampshire, United States
- Local Institution - 054, Hartsdale, New York, United States
- Weill Cornell Medical College, New York, New York, United States
- Concorde Medical Group, New York, New York, United States
- TrialSpark, New York, New York, United States
- Local Institution - 060, North Massapequa, New York, United States
- Local Institution - 156, Charlotte, North Carolina, United States
- Local Institution - 052, Winston-Salem, North Carolina, United States
- Local Institution - 170, Dayton, Ohio, United States
- Local Institution - 049, Hilliard, Ohio, United States
- Paramount Medical Research & Consulting, Llc, Middleburg Heights, Ohio, United States
- Local Institution - 087, Norman, Oklahoma, United States
- Local Institution - 294, Oklahoma City, Oklahoma, United States
- Local Institution - 185, Tulsa, Oklahoma, United States
- Local Institution - 217, Tulsa, Oklahoma, United States
- University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
- Local Institution - 034, Fort Sam Houston, Texas, United States
- Local Institution - 079, Houston, Texas, United States
- Local Institution - 196, Houston, Texas, United States
- Gulf Coast Research Group LLC, Houston, Texas, United States
- Accurate Clinical Research Inc, Pasadena, Texas, United States
- Local Institution - 071, Richardson, Texas, United States
- Local Institution - 178, San Antonio, Texas, United States
- Local Institution - 181, Temple, Texas, United States
- Local Institution - 292, Riverton, Utah, United States
- Local Institution - 030, Lynchburg, Virginia, United States
- The Gastroenterology Group, Reston, Virginia, United States
- Local Institution - 072, Richmond, Virginia, United States
- Local Institution - 172, Roanoke, Virginia, United States
- Local Institution - 089, La Crosse, Wisconsin, United States
- Local Institution - 309, Liverpool, New South Wales, Australia
- Local Institution - 318, New Lambton Heights, New South Wales, Australia
- Local Institution - 328, Herston, Queensland, Australia
- Local Institution - 313, Maroorchydore, Queensland, Australia
- Local Institution - 321, North Mackay, Queensland, Australia
- Local Institution - 312, South Brisbane, Queensland, Australia
- Local Institution - 307, Bedford Park, South Australia, Australia
- Local Institution - 326, Elizabeth Vale, South Australia, Australia
- Local Institution - 317, Clayton, Victoria, Australia
- Local Institution - 305, Fitzroy, Victoria, Australia
- Local Institution - 329, Geelong, Victoria, Australia
- Local Institution - 327, Melbourne, Victoria, Australia
- Local Institution - 315, Subiaco, Western Australia, Australia
- Local Institution - 726, Innsbruck, Austria
- Local Institution - 727, Sankt Pölten, Austria
- Local Institution - 336, Vienna, Austria
- Local Institution - 725, Vienna, Austria
- Local Institution - 753, Rousse, Bulgaria
- Local Institution - 750, Sofia, Bulgaria
- Local Institution - 755, Sofia, Bulgaria
- Local Institution - 756, Sofia, Bulgaria
- Local Institution - 752, Sofia, Bulgaria
- Local Institution - 554, Sofia, Bulgaria
- Local Institution - 269, Edmonton, Alberta, Canada
- Local Institution - 262, New Westminster, British Columbia, Canada
- Local Institution - 267, Vancouver, British Columbia, Canada
- Local Institution - 256, Brandon, Manitoba, Canada
- Local Institution - 266, Greater Sudbury, Ontario, Canada
- Local Institution - 264, Toronto, Ontario, Canada
- Local Institution - 257, Toronto, Ontario, Canada
- Local Institution - 254, Montreal, Quebec, Canada
- Local Institution - 270, Ottawa, Quebec, Canada
- Local Institution - 423, Changzhou, Jiangsu, China
- Local Institution - 369, Shanghai, Shanghai Municipality, China
- Local Institution - 482, Beijing, China
- Local Institution - 467, Beijing, China
- Local Institution - 379, Bengbu, China
- Local Institution - 485, Changchun, China
- Local Institution - 376, Changchun, China
- Local Institution - 421, Changsha, China
- Local Institution - 378, Changsha, China
- Local Institution - 414, Changzhou, China
- Local Institution - 419, Chengdu, China
- Local Institution - 422, Fuzhou, China
- Local Institution - 478, Guangzhou, China
- Local Institution - 472, Guangzhou, China
- Local Institution - 486, Guangzhou, China
- Local Institution - 470, Hangzhou, Zhejiang, China
- Local Institution - 491, Hefei, China
- Local Institution - 374, Kunming, China
- Local Institution - 383, Luzhou, China
- Local Institution - 488, Nanchang, China
- Local Institution - 418, Nanjing, China
- Local Institution - 375, Nanjing, China
- Local Institution - 487, Nanjing, China
- Local Institution - 473, Shanghai, China
- Local Institution - 380, Shanghai, China
- Local Institution - 377, Shanghai, China
- Local Institution - 458, Taichung City, China
- Local Institution - 373, Tianjin, China
- Local Institution - 475, Wuhan, China
- Local Institution - 474, Wuhan, China
- Local Institution - 483, Wuhan, China
- Local Institution - 381, Wuxi, China
- Local Institution - 415, Xi'an, China
- Local Institution - 420, Xi'an, China
- Local Institution - 370, Zhengzhou, China
- Local Institution - 397, Armenia, Colombia
- Local Institution - 398, Barranquilla, Colombia
- Local Institution - 395, Bogotá, Colombia
- Local Institution - 396, Cali, Colombia
- Local Institution - 394, Medellín, Colombia
- Local Institution - 613, Helsinki, Finland
- Local Institution - 614, Turku, Finland
- Local Institution - 647, Neuilly-sur-Seine, Cedex, France
- Local Institution - 639, Béziers, France
- Local Institution - 635, Blois, France
- Local Institution - 634, Caen, France
- Local Institution - 644, Colombes, France
- Local Institution - 632, Nantes, France
- Local Institution - 630, Pierre-Bénite, France
- Local Institution - 631, Saint-Priest-en-Jarez, France
- Local Institution - 786, Batumi, Georgia
- Local Institution - 779, Kutaisi, Georgia
- Local Institution - 454, Tbilisi, Georgia
- Local Institution - 778, Tbilisi, Georgia
- Local Institution - 782, Tbilisi, Georgia
- Local Institution - 552, Tbilisi, Georgia
- Local Institution - 793, Tbilisi, Georgia
- Local Institution - 740, Tbilisi, Georgia
- Local Institution - 783, Tbilisi, Georgia
- Local Institution - 784, Tbilisi, Georgia
- Local Institution - 785, Tbilisi, Georgia
- Local Institution - 335, Tbilisi, Georgia
- Local Institution - 455, Tbilisi, Georgia
- Local Institution - 781, Tbilisi, Georgia
- Local Institution - 780, Telavi, Georgia
- Local Institution - 629, Berlin, Germany
- Local Institution - 653, Berlin, Germany
- Local Institution - 648, Berlin, Germany
- Local Institution - 628, Berlin, Germany
- Local Institution - 664, Brandenburg an der Havel, Germany
- Local Institution - 732, Dachau, Germany
- Local Institution - 574, Frankfurt am Main, Germany
- Local Institution - 657, Frankfurt am Main, Germany
- Local Institution - 658, Halle, Germany
- Local Institution - 656, Halle, Germany
- Local Institution - 652, Hamburg, Germany
- Local Institution - 591, Hanover, Germany
- Local Institution - 649, Keil, Germany
- Local Institution - 337, Leipzig, Germany
- Local Institution - 660, Mainz, Germany
- Local Institution - 667, Münster, Germany
- Local Institution - 620, Neuruppin, Germany
- Local Institution - 584, Nürtingen, Germany
- Local Institution - 661, Stuttgart, Germany
- Local Institution - 790, Athens, Greece
- Local Institution - 588, Athens, Greece
- Local Institution - 791, Athens, Greece
- _and 168 more_

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `locations.local institution - 202|scottsdale|arizona|united states` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ucsd medical center|la jolla|california|united states` — added _(2026-05-12)_
- `locations.local institution - 010|lancaster|california|united states` — added _(2026-05-12)_
- `locations.southern california research institute medical group, inc.|los angeles|california|united states` — added _(2026-05-12)_
- `locations.matrix clinical research inc|los angeles|california|united states` — added _(2026-05-12)_
- `locations.facey medical foundation (parent)|mission hills|california|united states` — added _(2026-05-12)_
- `locations.local institution - 093|pasadena|california|united states` — added _(2026-05-12)_
- `locations.sutter medical group|roseville|california|united states` — added _(2026-05-12)_
- `locations.local institution - 280|sacramento|california|united states` — added _(2026-05-12)_
- `locations.local institution - 281|san francisco|california|united states` — added _(2026-05-12)_
- `locations.local institution - 124|west covina|california|united states` — added _(2026-05-12)_
- `locations.local institution - 065|colorado springs|colorado|united states` — added _(2026-05-12)_
- `locations.local institution - 182|bristol|connecticut|united states` — added _(2026-05-12)_
- `locations.local institution - 166|clearwater|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 084|clermont|florida|united states` — added _(2026-05-12)_
- `locations.american research institute inc|cutler bay|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 112|doral|florida|united states` — added _(2026-05-12)_
- `locations.riverside clinical research|edgewater|florida|united states` — added _(2026-05-12)_
- `locations.sih research|kissimmee|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 067|lighthouse pt|florida|united states` — added _(2026-05-12)_
- `locations.center for advanced gastroenterology|maitland|florida|united states` — added _(2026-05-12)_
- `locations.lmg research|miami|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 175|miami|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 081|miami|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 044|miami springs|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 192|new port richey|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 200|orlando|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 002|palmetto bay|florida|united states` — added _(2026-05-12)_
- `locations.theia clinical research, llc|pinellas park|florida|united states` — added _(2026-05-12)_
- `locations.precision clinical research, llc.|sunrise|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 183|tampa|florida|united states` — added _(2026-05-12)_
- `locations.apex clinical research|tampa|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 107|tampa|florida|united states` — added _(2026-05-12)_
- `locations.local institution - 037|atlanta|georgia|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03440385.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03440385*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*