Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Ulcerative Colitis (UC) ABT-494 Moderately to Severely Active UC Colitis Ulcer Colitis, Ulcerative ABT-494 Dose B ABT-494 Dose A ABT-494 Dose C ABT-494 Dose D

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD accepting new patients
    La Jolla California 92037 United States
  • Medical Assoc Research Grp not yet accepting patients
    San Diego California 92123 United States
  • United Gastroenterologists accepting new patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02819635
Phase
Phase 3
Study Type
Interventional
Last Updated
April 12, 2018