Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This study is designed to evaluate the long-term safety and efficacy of ABT-494 in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 (Substudies 1 and 2), who have had loss of response during the maintenance period of Study M14-234 (Substudy 3), or who have successfully completed Study M14-234.

Official Title

A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects With Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis (UC) ABT-494 Open-Label Extension (OLE) Safety Efficacy Colitis Ulcer Colitis, Ulcerative

Eligibility

You can join if…

Open to people ages 18-99

  • Participant has not achieved clinical response at the end of the induction period(Week 8) in Study M14-234 (Sub-studies 1 and 2), has had loss of response during the maintenance period of Study M14-234 (Sub-study 3), or has successfully completed Study M14-234.
  • If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing.
  • 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.
  • Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study(Study M14-234).
  • Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

You CAN'T join if...

  • For any reason participant is considered by the investigator to be an unsuitable candidate.
  • Female participant with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study.
  • Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study.Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
  • Current evidence of active or untreated latent tuberculosis.
  • Participant with a poorly controlled medical condition, such as uncontrolled diabetes,unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.

Locations

  • UC San Diego Health System
    La Jolla California 92093 United States
  • Medical Assoc Research Grp
    San Diego California 92123 United States
  • United Gastroenterologists
    Murrieta California 92563 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03006068
Phase
Phase 3
Study Type
Interventional
Last Updated
April 9, 2018