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A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease
EU CTIS ID: 2022-501645-70-00
What this study is testing
Part 1: The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy. Part 2: The objective is to evaluate the long-term safety of risankizumab up to 220 weeks in subjects who received risankizumab during Part 1 and have completed the Week 48 visit. Primary Treatment Extension (PTE) The objective of the optional PTE is to provide Part 2 completers with continuous treatment of risankizumab with the aim to ensure uninterrupted care in accordance with local regulations until commercially available and/or the subject can access treatment locally for up to a maximum of approximately 3 years from the Part 2 completion visit date (Week 268). Additional objectives of the PTE are to continue to investigate and evaluate long-term safety data for risankizumab.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female aged ≥ 18 to ≤ 80 years of age at the Baseline visit. Confirmed diagnosis of Crohns disease (CD) for at least 3 months prior to Baseline.
- Crohn's disease activity index (CDAI) score 220 – 450 at Baseline. Confirmed diagnosis of moderate to severe Crohns Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
- Demonstrated intolerance or inadequate response to one or more anti- TNF therapies
- If female, subject must meet the contraception recommendations
You likely can't join if
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Subjects with unstable doses of concomitant CD therapy
- Receipt of CD approved biologic agents prior to baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol)
- Subject with prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- Subject with complications of CD (strictures, short bowel, etc.)
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- China
- Japan
- Australia
- United Kingdom
- Chile
- Israel
- Russian Federation
- Turkey
- United States
- Brazil
- Canada
- Ukraine
- Korea, Republic of
- Switzerland
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; China; Japan; Australia; United Kingdom; Chile and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.