This study is in progress, not accepting new patients

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 16-80 (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Melvin Heyman (ucsf)
Headshot of Melvin Heyman
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. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
  • 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.
  • OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

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, Monoclonal Antibodies, Risankizumab IV, Risankizumab SC, Risankizumab On-Body Injector (OBI), 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 16-80

  • 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

  • UC San Diego Health Systems /ID# 155555
    La Jolla California 92093 United States
  • University of California San Francisco - Mission Bay /ID# 157127
    San Francisco California 94158 United States
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657
    Los Angeles California 90067-2001 United States
  • TLC Clinical Research Inc /ID# 212719
    Los Angeles California 90048 United States
  • Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 163839
    West Hollywood California 90048 United States
  • Duplicate_Newport Huntington Medical Group /ID# 213035
    Huntington Beach California 92648 United States
  • Southern California Res. Ctr. /ID# 211991
    Coronado California 92118-1408 United States
  • United Medical Doctors /ID# 207888
    Los Alamitos California 90720-3309 United States

Lead Scientist at University of California Health

  • Melvin Heyman (ucsf)
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 334 research publications. Research interests: inflammatory bowel disease (ulcerative colitis · Crohn's disease) · Pediatric Nutrition · Pancreatitis in children (acute and chronic) · Mentoring and Career Development · Fellowship Training · Gastroesophageal Reflux Disease

Details

Status
in progress, not accepting new patients
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 research study
Study Type
Interventional
Participants
About 1336 people participating
Last Updated