A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
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- STATUS
- Recruiting
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- sponsor
- AbbVie
Summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Description
This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.
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, or mycophenolate mofetil 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).
- Screening laboratory and other analyses show any abnormal results.
Details
| Condition | Ulcerative Colitis |
|---|---|
| Clinical Study Identifier | TX153756 |
| Sponsor | AbbVie |
| Last Modified on | 25 March 2021 |
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