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
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1000 Oakland Drive
Kalamazoo, Michigan 49008
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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...
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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...
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260 Lookout Pl # 201
Maitland, Florida 32751
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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...
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Atlanta, Georgia 30322
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Baton Rouge, Louisiana 70809
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Boston, Massachusetts 02118
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Bristol, Connecticut 06010
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Charlotte, North Carolina 28209
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Clearwater, Florida 33765
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Clermont, Florida 34711
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Colorado Springs, Colorado 80907
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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...
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Cutler Bay, Florida 33157
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3650 Northwest 82nd Avenue
Doral, Florida 33166
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Evansville, Indiana 47714
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Fort Sam Houston, Texas 78234
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Hartsdale, New York 10530
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Houston, Texas 77062
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Idaho Falls, Idaho 83404
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Kansas City, Missouri 64111
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La Crosse, Wisconsin 54601
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Las Vegas, Nevada 89145
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
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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...
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Lighthouse Point, Florida 33064
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Liverpool, New South Wales 2170
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Miami Springs, Florida 33166
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Middleburg Heights, Ohio 44130
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Minneapolis, Minnesota 55455
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15451 San Fernando Mission Boulevard
Mission Hills, California 91345
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7114 Congress Street
New Port Richey, Florida 34655
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7912 Forest City Road
Orlando, Florida 32810
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4820 Park Boulevard North
Pinellas Park, Florida 33781
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1939 Roland Clarke Place
Reston, Virginia 20191
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Rochester, Minnesota 55905
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1 Medical Plaza Drive
Roseville, California 95661
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520 East Euclid Avenue
San Antonio, Texas 78212
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
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