Summary

for people ages 16-80 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991

Keywords

Crohn's Disease risankizumab ABBV-066 BI 655066 Crohn Disease risankizumab IV risankizumab SC Open-label Risankizumab (Sub-Study 3) Double-blind Risankizumab Dose 2 (Sub-Study 1) Maintenance Risankizumab Dose 1 (Sub-Study 2) Double-blind Risankizumab Dose 1 (Sub-Study 1) Maintenance Risankizumab Dose 2 (Sub-Study 2)

Eligibility

You can join if…

Open to people ages 16-80

  • Subjects who have completed Study M16-006 or Study M15-991 and have achieved clinical response

You CAN'T join if...

  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Studies M16 006 or M15-991 that in the Investigator's judgment makes the subject unsuitable for this study
  • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-006 or M15-991

Locations

  • UC San Diego Health Systems not yet accepting patients
    San Diego California 92037 United States
  • United Gastroenterologists not yet accepting patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03105102
Phase
Phase 3
Study Type
Interventional
Last Updated
June 13, 2018