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 |
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.
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
sites
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - The Center for Vascular Biol
Boston, Massachusetts 02115
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
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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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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