A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. - Trial NCT06063967

Timeline & Enrollment

Primary Outcome

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI 150),Percentage of Participants With Endoscopic Response

Summary

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness,
 swelling), in the digestive tract, most often affecting the bowels. It can cause many
 different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study
 will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in
 treating moderately to severely active CD in adult participants.
 
 Risankizumab is an approved drug for adults with CD. This study comprises of a Period A and a
 Period B. In Period A, participants are placed in 1 of 2 groups to receive either
 risankizumab SC or Placebo. In Period B, based on response, participants will receive
 risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at
 Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in
 period B will receive risankizumab SC. Approximately 276 adult participants with a diagnosis
 of moderately to severely active CD will be enrolled in approximately 250 sites globally.
 
 Participants will receive SC induction treatment of risankizumab or matching placebo for up
 to 24 weeks in Period A and B. The duration of the study will be approximately 49 weeks.

ICD-10 Classifications