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
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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1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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