Induction Study #1 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:February 27, 2018
End Date:August 31, 2020
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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INDUCTION STUDY # 1, 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
94
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Catonsville, Maryland 21228
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700 South Torrence
Charlotte, North Carolina 28204
704-374-0030
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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610 3rd St # 206
Macon, Georgia 31201
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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6719 Alvarado Road
San Diego, California 92120
619-287-6000
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Asheville, North Carolina 28801
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Atlanta, Georgia 30342
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Beachwood, Ohio 44122
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Bronx, New York 10468
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Brooklyn, New York 11230
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2001 Oriental Boulevard
Brooklyn, New York 11235
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Caro, Michigan 48723
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1025 Morehead Medical Drive
Charlotte, North Carolina 28204
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303 East Superior Street
Chicago, Illinois 60611
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Chula Vista, California 91911
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Ciudad Autonoma de Buenos Aires,
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Clearwater, Florida 33762
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Clive, Iowa 50325
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Columbus, Georgia 31904
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
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Fishkill, New York 12524
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Gainesville, Virginia 20155
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Garden Grove, California 92843
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11 Murray Street
Glens Falls, New York 12801
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215 West Washington Street
Grafton, Wisconsin 53024
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Great Neck, New York 11021
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Greenville, North Carolina 27834
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
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Hialeah, Florida 33016
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8001 West 26th Avenue
Hialeah, Florida 33016
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Houma, Louisiana 70360
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13215 Dotson Road
Houston, Texas 77070
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Houston, Texas 77084
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
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Lake Charles, Louisiana 70601
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Lexington, Kentucky 40536
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Los Angeles, California 90067
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10535 Hospital Way
Mather, California 95665
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Mentor, Ohio 44060
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Miami, Florida 33125
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6141 Sunset Drive
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Mission Viejo, California 92691
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1168 Goodlette-Frank Road
Naples, Florida 34102
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Nashville, Tennessee 37211
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New Haven, Connecticut 6520
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New Orleans, Louisiana 70115
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New Smyrna Beach, Florida 32174
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Oceanside, California 92056
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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599 Delaware Avenue
Orchard Park, New York 14127
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Orlando, Florida 32819
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Rialto, California 92377
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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San Antonio, Texas 78215
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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Shreveport, Louisiana 71130
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Southfield, Michigan 48034
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505 Nolen Drive
Southlake, Texas 76092
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Spokane, Washington 99204
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State College, Pennsylvania 16703
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2790 Godwin Boulevard
Suffolk, Virginia 23434
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1109 East Reelfoot Avenue
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Urbana, Illinois 61801
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14860 Roscoe Boulevard
Weeki Wachee, Florida 34607
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