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

  • STATUS
    Recruiting
  • sponsor
    AbbVie
Updated on 25 March 2021

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:
  1. Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
  2. Current diagnosis of fulminant colitis and/or toxic megacolon.
  3. Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
  4. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
  5. Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.
  6. Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
  7. Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib).
  8. Screening laboratory and other analyses show any abnormal results.

Details
Clinical Study IdentifierTX153756
SponsorAbbVie
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
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 corticosteroids, immunosuppressants, and/or biologic therapies
If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing
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
Male participants must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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