Risankizumab vs Ustekinumab for Crohn's Disease
(SEQUENCE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received certain biologic agents before the trial, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drugs Risankizumab and Ustekinumab for treating Crohn's Disease?
Ustekinumab has been shown to help about 50% of Crohn's Disease patients achieve clinical remission after one year, and it is generally well tolerated. Risankizumab and Ustekinumab are both approved for treating moderate to severe Crohn's Disease, with ongoing studies comparing their effectiveness.12345
Is Ustekinumab safe for treating Crohn's Disease?
How do the drugs Risankizumab and Ustekinumab differ from other treatments for Crohn's Disease?
What is the purpose of this trial?
This trial is testing a new drug, risankizumab, against an existing drug, ustekinumab, to see which works better for adults with moderate to severe Crohn's Disease. The drugs help by reducing gut inflammation. Participants will receive the drugs through injections and be monitored over time. Risankizumab has been studied as a maintenance therapy for moderately to severely active Crohn's disease in previous trials.
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
Adults with moderate to severe Crohn's Disease for at least 3 months, having a CDAI score of 220-450. They must have had an inadequate response or intolerance to anti-TNF therapies and cannot have used p19 or p40 inhibitors like risankizumab or ustekinumab before.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive intravenous doses of risankizumab or ustekinumab at Week 0, 4, 8 followed by subcutaneous doses every 8 weeks through Week 48
Treatment Part 2
Participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive subcutaneous risankizumab for up to an additional 220 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Risankizumab
- Ustekinumab
Risankizumab is already approved in Canada, United States, European Union for the following indications:
- Moderate-to-severe Crohn's disease
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
- Psoriatic arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois