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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:March 7, 2018
End Date:August 30, 2020
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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INDUCTION STUDY # 2, A PHASE 3, MULTI CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE

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.


Inclusion Criteria:

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

1. Aged 18-75 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 2 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.

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. Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic
colitis or known strictures or stenosis leading to symptoms of obstruction.

2. Current stoma, ileal-anal pouch anastomosis, symptomatic fistula, or need for
ileostomy or colostomy
We found this trial at
79
sites
Philadelphia, Pennsylvania 19104
414
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Philadelphia, PA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
270
mi
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Chicago, IL
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
167
mi
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Indianapolis, IN
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260 Lookout Pl # 201
Maitland, Florida 32751
788
mi
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Maitland, FL
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
822
mi
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Tampa, FL
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Atlanta, Georgia 30322
432
mi
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Atlanta, GA
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Baton Rouge, Louisiana 70809
801
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Baton Rouge, LA
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925
mi
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Beaumont, TX
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Boston, Massachusetts 02118
642
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Boston, MA
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Bristol, Connecticut 06010
539
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Bristol, CT
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Charlotte, North Carolina 28209
351
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Charlotte, NC
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Clearwater, Florida 33765
829
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Clearwater, FL
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Clermont, Florida 34711
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mi
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Clermont, FL
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Colorado Springs, Colorado 80907
1163
mi
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Colorado Springs, CO
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
1
mi
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Columbus, OH
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1939
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Corona, CA
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Cutler Bay, Florida 33157
1006
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Cutler Bay, FL
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63
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Dayton, OH
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430
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Decatur, GA
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3650 Northwest 82nd Avenue
Doral, Florida 33166
990
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Doral, FL
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Edgewater, Florida 32132
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Edgewater, FL
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Evansville, Indiana 47714
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Evansville, IN
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Fort Sam Houston, Texas 78234
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Fort Sam Houston, TX
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Hartsdale, New York 10530
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Hartsdale, NY
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Houston, Texas 77062
992
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Houston, TX
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Houston, Texas 77089
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Houston, TX
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Houston, Texas 77004
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Houston, TX
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Idaho Falls, Idaho 83404
1506
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Idaho Falls, ID
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1000 Oakland Drive
Kalamazoo, Michigan 49008
208
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Kalamazoo, MI
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Kansas City, Missouri 64111
618
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Kansas City, MO
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Kissimmee, Florida 34759
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Kissimmee, FL
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La Crosse, Wisconsin 54601
498
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La Crosse, WI
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La Jolla, California 92093
1950
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La Jolla, CA
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Lake Charles, Louisiana 70601
885
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Lake Charles, LA
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Lancaster, California 93534
1950
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Lancaster, CA
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Las Vegas, Nevada 89145
1756
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Las Vegas, NV
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
965
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Lauderdale Lakes, FL
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
609
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Lebanon, NH
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Lighthouse Point, Florida 33064
960
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Lighthouse Point, FL
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Liverpool, New South Wales 2170
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Liverpool,
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Los Angeles, CA
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Lynchburg, Virginia 24502
273
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Lynchburg, VA
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
802
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Marrero, LA
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Miami, Florida 33125
993
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Miami, FL
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995
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Miami, FL
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989
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Miami, FL
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Miami Springs, Florida 33166
989
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Middleburg Heights, Ohio 44130
116
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Middleburg Heights, OH
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Minneapolis, Minnesota 55455
623
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Minneapolis, MN
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15451 San Fernando Mission Boulevard
Mission Hills, California 91345
1978
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Mission Hills, CA
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7114 Congress Street
New Port Richey, Florida 34655
808
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New Port Richey, FL
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New York, New York 10021
480
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New York, NY
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New York, New York 10016
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New York, New York 10024
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853
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Norman, OK
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505
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North Massapequa, NY
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175
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Novi, MI
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7912 Forest City Road
Orlando, Florida 32810
788
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Orlando, FL
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Palmetto Bay, Florida
1003
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Palmetto Bay, FL
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2099
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Palo Alto, CA
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Pasadena, California 91105
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Pasadena, Texas 77505
988
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4820 Park Boulevard North
Pinellas Park, Florida 33781
838
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1939 Roland Clarke Place
Reston, Virginia 20191
310
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Reston, VA
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Richardson, Texas 75082
895
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Richardson, TX
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Richmond, Virginia 23249
342
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Richmond, VA
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Roanoke, Virginia
249
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Roanoke, VA
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Rochester, Minnesota 55905
559
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Rochester, MN
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1 Medical Plaza Drive
Roseville, California 95661
2027
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Roseville, CA
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520 East Euclid Avenue
San Antonio, Texas 78212
1137
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Scottsdale, Arizona 85258
1650
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Tampa, Florida 33612
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Tampa, Florida 33614
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Temple, Texas 76508
1011
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Temple, TX
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Topeka, KS
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Tulsa, OK
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West Covina, California 91790
1955
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West Covina, CA
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
306
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607
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Worcester, MA
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