Eine Studie über die Wirksamkeit und Sicherheit von Risankizumab bei Patienten mit mittelschwerem bis schwerem aktivem Morbus Crohn

Drug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SC

Inclusion Criteria:

- Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to
local regulations, at the Baseline Visit. Where locally permissible, participants 16
to < 18 years of age who meet the definition of Tanner stage 5 for development at the
Baseline Visit.

- Diagnosis of CD for at least 3 months prior to Baseline.

- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

- Demonstrated intolerance or inadequate response to conventional or to biologic therapy
for CD.

- If female, participant must meet the contraception recommendations.

Exclusion Criteria:

- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

- Participants with unstable doses of concomitant Crohn's disease therapy.

- Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab,
certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab
within 12 weeks prior to Baseline), or any investigational biologic or other agent or
procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.

- Prior exposure to p19 inhibitors (e.g., risankizumab).

- Complications of Crohn's disease.

- Having an ostomy or ileoanal pouch.

- Known active Coronavirus Disease 2019 (COVID-19) infection.