Risankizumab for Crohn's Disease
(FORTIFY Trial)
Trial Summary
Do I need to stop my current medications for the Risankizumab trial?
The trial information does not specify if you need to stop your current medications. However, it mentions that participants must comply with prior and current medication requirements from previous studies, so it's best to discuss your specific situation with the study team.
What data supports the effectiveness of the drug Risankizumab for Crohn's Disease?
Research shows that Risankizumab, which targets a specific part of the immune system, was effective in helping patients with Crohn's disease achieve remission (a period without symptoms) and improve their condition in several studies. It was found to be better than a placebo (a substance with no active drug) in both short-term and long-term treatment.12345
What is known about the safety of risankizumab for Crohn's disease?
Risankizumab has been shown to have acceptable safety in both short-term and long-term studies for patients with moderate-to-severe Crohn's disease. It has been evaluated in various trials, including phase 2 and phase 3 studies, and has demonstrated a safety profile that is considered acceptable for use in these patients.13678
How is the drug Risankizumab unique for treating Crohn's disease?
What is the purpose of this trial?
This trial tests risankizumab, a medication for Crohn's disease, in patients who have already responded well to it. The goal is to see if continued use can maintain their improvement by reducing inflammation in the digestive tract. Risankizumab is approved by the FDA for treating moderate to severe Crohn's disease.
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for people with moderately to severely active Crohn's Disease who've had a positive response to risankizumab in previous studies. They should be willing and able to self-inject the medication using an on-body injector, have been stable on their current dose for at least 16 weeks, and not require rescue treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maintenance therapy with risankizumab or placebo for 52 weeks
Open-label extension
Participants receive open-label risankizumab to evaluate long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo for Risankizumab IV
- Placebo for Risankizumab SC
- Risankizumab IV
- Risankizumab On-Body Injector (OBI)
- Risankizumab SC
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