This study is accepting new patients by invitation only

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
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 participants 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 participants 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 participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18-80

  • Participants who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.

You CAN'T join if...

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.

Locations

  • UC San Diego Health Systems /ID# 155555
    La Jolla California 92093 United States
  • Southern California Res. Ctr. /ID# 211991
    Coronado California 92118-1408 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT03105102
Phase
Phase 3
Study Type
Interventional
Last Updated