Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Gastrointestinal, Stomach, Esophageal
Enrollment Eligibility
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.