An Open Label, Single Group, Long Term Safety Extension Trial of BI655066/ABBV-066 (Risankizumab), in Patients with Moderately to Severely Active Crohn's Disease.

Crohn*s disease is a chronic inflammatory bowel disease (IBD) that may affect
any part of the gastrointestinal tract from
mouth to anus, causing a wide variety of symptoms.
The intensity of inflammation of the bowel can vary widely; people with Crohn's
disease experience chronic recurring
periods of *flare-ups* (fast progression of disease called acute phase) and
remission (quiet periods which nearly do not
require treatment called the chronic phase).
About 35.000 Dutch people and 15.000 Belgian people have IBD. 1000 subjects are
newly diagnosed per year. The
disease is mainly diagnosed between the age of 15-30 years.
After diagnosing the disease medicinal treatment will be started to compromise
the inflammation, and to suppress the
appearance of new inflammatory spots. In addition to that prescriptions to
prevent anemia and diarrhea are also frequently
prescribed.
Nearly 80% of Crohn*s disease patients require long medicinal treatment and
guidance from a medical specialist. These
drugs may work, but also have negative side effects; many patients show to be
intolerant to anti-TNF, which is most
frequently prescribed.

Risankizumab is an experimental drug, what will be used in patients with
Crohn*s disease for the first time. It was studied in a
clinical trial with 31 patients with psoriasis, a skin disease.
Risankizumab is a *humanized monoclonal antibody* specific to IL-23 p19; this
means that Risankizumab neutralizes a protein *IL-
23 p19*, which is involved in the progression of Crohn*s disease.
Neutralizingthis protein will have effect in less decrease of the health
condition of subjects with Crohn's disease.

In the preceeding trial 1311.6, the patients have shown that treatment with the
study drug gives potential benefit as they have either achieved clinical
response or clinical remission.

That patients who have had clinical response or clinical remission after use
with Risankizumab can continue using Risankizumab. Also long term safety of
Risankizumab will be assessed in patients who were diagnosed with moderate to
severe Crohn's disease.

An open label, multi-center, fase II trial. Worlwide, 56 patients will be
included in this trial and 4 patients will be included in the Netherlands. The
study will last for 4 years and the patients will have onsite study visits at
the clinic every 8 weeks, until end of trial visit.

Patients will receive 2 sub cutaneous injections at every study visit, which
will occur every 8 weeks, until end of trial visit. One syringe contains 90
mg/ml of Risankizumab.

The burden for subjects will mainly be based on the visits a subject is
requested to bring to the hospital & the kind of
examinations a subject is requested to undergo during the trial with trial
purposes:
In respect to time investments subjects will be in close contacxt with their
study physician for a period of 4 years.
Depending of the specific visit, this visit will take 2 to 6 hours of the
subject*s time per visit. In total every patient will be
requested to spend an estimate of 99 hours (in this timeframe of 4 years total)
at the hospital for interviews with the
study staff and to undergo examinations.
During 5 visits the time spent onsite by the subject will take 4 to 6 hours per
visit, due to the fact a colonoscopy needs
to be performed. The performer of the colonoscopy will most probably ask
patients to bring some familiar person to the clinic with them, to
stay with the subject during the examination and to bring them home after the
clinic visit.
With respect to invasive procedures, subjects will be asked to undergo more
frequent colonoscopies compared to the
normal clinical standard. For this study colonoscopies are required to evaluate
the effect of the investigational drug.

Risks:
As Risankizumab is an experimental drug, the subjects may suffer from adverse
events. It is also not known if there are more adverse events reported as this
trial will go on for 4 years. The physicians will however receive all safety
updates to share with the subjects.
There is a chance that subjects experience side effects of the procedures done
for a colonoscopy. The procedure for the colonoscopy is the same in this
clinical trial as in a clinical setting when subjects are not participating in
the trial, but as the colonoscopies will occur more frequent, the chances are
that subjects may suffer more from side effects due to colonoscopy.