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 |
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.
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
1000 Oakland Drive
Kalamazoo, Michigan 49008
Kalamazoo, Michigan 49008
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of South Florida The University of South Florida is a high-impact, global research university...
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The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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15451 San Fernando Mission Boulevard
Mission Hills, California 91345
Mission Hills, California 91345
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
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...
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