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

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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.


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
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924 East 57th Street
Chicago, Illinois 60637
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Charlotte, North Carolina 28203
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