ABBV-066 M23-784 Ph3 Crohns
Research type
Research Study
Full title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn’s Disease.
IRAS ID
1009003
Contact name
Dr Kamal Patel
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2023-507326-16
Research 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.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
24/NW/0023
Date of REC Opinion
15 Mar 2024
REC opinion
Further Information Favourable Opinion