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 Ulcerative Colitis

UC is a chronic, relapsing inflammatory disease of the large intestine
characterized by inflammation and ulceration of mainly the mucosal and
occasionally submucosal intestinal layers. The clinical course is marked by
exacerbation and remission.
The aim of medical treatment in UC is to control inflammation and reduce
symptoms. Available pharmaceutical therapies are limited, do not always
completely abate the inflammatory process, and may have significant adverse
effects. Thus, there remains a clear medical need for additional therapeutic
options in UC for patients with inadequate response to or intolerance to
conventional therapies and biologic therapies.

This study has been transitioned to CTIS with ID 2023-506994-36-00 check the CTIS register for the current data.

Study M16-066 comprises three sub-studies:
Sub-study 1: Randomized, double-blind, placebo-controlled maintenance
To evaluate the efficacy and safety of risankizumab versus placebo as
maintenance therapy in subjects with moderately to severely active ulcerative
colitis (UC) who responded to IV risankizumab induction treatment in Study
M16-067.

Sub-study 2: Randomized, exploratory maintenance
To evaluate the efficacy and safety of two different dosing regimens for
risankizumab (therapeutic drug monitoring vs clinical assessment for dose
escalation) as maintenance therapy in subjects with moderately to severely
active UC who responded to induction treatment in Study M16-067.

Sub-study 3: Open-label long term extension
To evaluate long-term safety of risankizumab in subjects who completed
Sub-study 1 or 2 or subjects responded to induction treatment in study M16-067
with no final endoscopy due to coronavirus COVD-19 pandemic or due to the
geo-political conflict in Ukraine and surrounding impacted regions. Additional
objectives are to further investigate longterm efficacy and tolerability of
risankizumab.
The CTE is an open-label extension for Substudy 3 completers to ensure
continuous treatment with risankizumab until such time that risankizumab
becomes commercially available and/or the subject can access treatment locally
or can transition to a Continued Treatment for Trial Participants Open-Label
Extension study.

This is a phase 3, multicenter, randomized, double-blind, placebo controlled
52-week maintenance and open-label extension study to assess the efficacy and
safety of risankizumab in subjects with Ulcerative Colitis who responded to
induction treatment in M16-067.

Subjects receive once every eight weeks SC risankizumab or SC placebo. They
receive this medication until the end of the study or till premature
discontinuation. For subjects requiring rescue therapy, they will receive once
risankizumab IV followed by once every 8 weeks SC Risankizumab.

There will be higher burden for subjects participating in this trial compared
to their standard of care. Subjects will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling and filling in questionnaires. Subjects will also be tested for
TB and pregnancy. Subjects will also complete a daily diary. Women of
Childbearing Potential should practice a method of birth control, during the
study through at least 140 days after the last dose of study drug.
Subjects will either receive risankizumab and/or placebo during the study. The
most common side effects reported during previous studies of risankizumab were
nausea, abdominal pain, joint pain and headache.
The hypothesis that risankizumab should be effective in treating inflammation
in patients with ulcerative colitis who are unable to tolerate or who have had
an insufficient response to treatment with some currently available
medications, indicates that there is an acceptable rationale to conduct this
study. The risks and burden associated with participating in this study are
acceptable in regards to the potential benefit study subjects could possibly
have.