A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 11/8/2017 |
Start Date: | March 17, 2015 |
End Date: | August 4, 2017 |
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
to severely active Crohn's Disease with a history of inadequate response to or intolerance to
Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
to severely active Crohn's Disease with a history of inadequate response to or intolerance to
Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
Inclusion Criteria:
1. Diagnosis of Crohn's disease (CD) for at least 90 days.
2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
equal to 450.
3. Subject inadequately responded to or experience intolerance to previous treatment with
immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).
Exclusion Criteria:
1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
2. Subject who has had surgical bowel resections in the past 6 months or is planning
resection.
3. Subjects with an ostomy or ileoanal pouch.
4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
5. Subject who has short bowel syndrome.
6. Subject with recurring infections or active Tuberculosis (TB).
We found this trial at
52
sites
7000 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
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325 Pittsboro Street
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
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2015 Randolph Road
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
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1000 Northern Boulevard
Great Neck, New York 11021
Great Neck, New York 11021
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1150 North 35th Avenue
Hollywood, Florida 33021
Hollywood, Florida 33021
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9500 Gilman Drive
La Jolla, California 92093
La Jolla, California 92093
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3201 South 16th Street
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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505 Parnassus Avenue
San Francisco, California 94143
San Francisco, California 94143
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2751 Albert L Bicknell Drive
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
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701 West Morse Boulevard
Winter Park, Florida 32789
Winter Park, Florida 32789
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