Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Melvin Heyman

Description

Summary

The study consists of 4 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 intravenous 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, another AbbVie risankizumab Crohn's disease study, 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; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.

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 SKYRIZI Crohn's Disease (CD) Crohn Disease Antibodies, Monoclonal Risankizumab IV Risankizumab SC Risankizumab On-Body Injector (OBI) 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) Risankizumab On-Body Injector and Open Label (Sub-Study 4)

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 other AbbVie risankizumab Crohn's disease study.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
  • Sub-Study 4:
  • Participants receiving maintenance treatment in Sub-study 3 and willing to comply with the requirements of Sub-study 4, including self-administration of sub-cutaneous injections using the on-body injector (OBI).
  • Participant has received at least 16 weeks of stable dosing with risankizumab in Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the 72-week mark).

You CAN'T join if...

  • Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie risankizumab Crohn's disease study if the final endoscopy was performed prior to enter Study M16-000 OR 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 another AbbVie risankizumab Crohn's disease study 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 another AbbVie risankizumab Crohn's disease study.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or another AbbVie risankizumab Crohn's disease study.
  • 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

  • University of California, San Francisco - 16th St /ID# 157127
    San Francisco California 94158 United States
  • TLC Clinical Research Inc /ID# 212719
    Los Angeles California 90048 United States
  • Cedars-Sinai Medical Center - West Hollywood /ID# 163839
    West Hollywood California 90048 United States
  • Gastrointestinal Biosciences /ID# 162657
    Los Angeles California 90067-2001 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03105102
Phase
Phase 3
Study Type
Interventional
Last Updated