A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/28/2019 |
Start Date: | September 26, 2016 |
End Date: | February 24, 2022 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the
dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical
remission in order to identify the induction dose of upadacitinib for further evaluation in
sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of
upadacitinib compared to placebo in inducing clinical remission in participants. The
objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to
placebo in achieving clinical remission in participants who had a response following
induction with upadacitinib.
dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical
remission in order to identify the induction dose of upadacitinib for further evaluation in
sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of
upadacitinib compared to placebo in inducing clinical remission in participants. The
objective of sub-study 3 is to evaluate the efficacy and safety of upadacitinib compared to
placebo in achieving clinical remission in participants who had a response following
induction with upadacitinib.
Inclusion Criteria:
- Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by
colonoscopy during the Screening Period, with exclusion of current infection, colonic
dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent
with the diagnosis of UC, in the assessment of the Investigator, must be available.
- Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic
sub score of 2 to 3 (confirmed by central reader).
- Demonstrated an inadequate response to, loss of response to, or intolerance to oral
aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.
- If female, participant must meet the criteria for Contraception Recommendations.
- Female participants of childbearing potential must have a negative serum pregnancy
test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit
prior to study drug dosing.
Exclusion Criteria:
- Participant with current diagnosis of Crohn's disease (CD) or diagnosis of
indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Participant with disease limited to the rectum (ulcerative proctitis) during the
Screening endoscopy.
- Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30
days prior to Baseline.
- Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the
Screening Period.
- Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib,
filgotinib, upadacitinib).
- Screening laboratory and other analyses show any abnormal results.
We found this trial at
137
sites
1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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3205 Fire Road
Egg Harbor Township, New Jersey 08234
Egg Harbor Township, New Jersey 08234
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1401 Professional Boulevard
Evansville, Indiana 47714
Evansville, Indiana 47714
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