Risankizumab for Crohn's Disease
(AFFIRM Trial)
Recruiting in Palo Alto (17 mi)
+160 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must not be taking: P19 inhibitors
Disqualifiers: Ulcerative colitis, Indeterminate colitis, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A 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. In Period C, eligible participants will receive open-label risankizumab SC Dose D. 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 followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that participants with unstable doses of their Crohn's disease therapy are excluded. This might mean that you need to be on a stable dose of your current medication to participate.
What data supports the effectiveness of the drug Risankizumab for Crohn's Disease?
Research shows that Risankizumab, a drug that targets a specific part of the immune system, helped people with Crohn's Disease achieve clinical remission (symptom relief) and improved gut health in several studies. It was effective both as an initial treatment and for long-term maintenance.
12345Is risankizumab safe for humans?
Risankizumab has been shown to have acceptable safety in clinical trials for Crohn's disease, with studies evaluating its long-term safety and real-world adverse events. It is also approved for treating plaque psoriasis, indicating its general safety in humans.
12467How is the drug Risankizumab different from other treatments for Crohn's disease?
Risankizumab is unique because it targets interleukin-23 (IL-23), a protein involved in inflammation, and is used both as an induction and maintenance therapy for Crohn's disease. It is administered intravenously for induction and subcutaneously for maintenance, offering a novel approach compared to other treatments.
12345Eligibility Criteria
Adults with moderately to severely active Crohn's Disease who haven't responded well to other treatments can join this study. They must have a confirmed diagnosis for at least 3 months and show clear signs of inflammation in their bowels.Inclusion Criteria
My Crohn's disease hasn't improved with standard or advanced treatments.
You have been determined to exhibit moderate-to-severe Crohn's Disease (CD) according to a comprehensive assessment instrument.
You have had a diagnosis of Crohn's Disease verified by biopsy for at least three months prior to the start of this study.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Period A
Participants receive risankizumab Dose A or placebo for up to 12 weeks
12 weeks
Regular visits for monitoring and administration
Treatment Period B
Based on response, participants receive risankizumab Dose B or placebo for up to 12 weeks. Participants with inadequate response receive Dose C
12 weeks
Regular visits for monitoring and administration
Open-label Extension Period C
Eligible participants receive open-label risankizumab Dose D for 52 weeks
52 weeks
Regular visits for monitoring and administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing Risankizumab, an approved drug for Crohn's Disease, given as a subcutaneous injection. Participants are randomly assigned to get either the real drug or a placebo during two periods, totaling about 49 weeks.
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Period C: Open-Label Risankizumab Dose DExperimental Treatment1 Intervention
Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
Group II: Period B: Risankizumab Dose CExperimental Treatment1 Intervention
Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
Group III: Period B: Risankizumab Dose BExperimental Treatment1 Intervention
Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks.
Group IV: Period A: Risankizumab Dose AExperimental Treatment1 Intervention
Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
Group V: Period B: PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B.
Group VI: Period A: PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
Risankizumab is already approved in Canada, United States, European Union for the following indications:
🇨🇦 Approved in Canada as Skyrizi for:
- Moderate-to-severe Crohn's disease
🇺🇸 Approved in United States as Skyrizi for:
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
🇪🇺 Approved in European Union as Skyrizi for:
- Moderate-to-severe Crohn's disease
- Moderate-to-severe plaque psoriasis
- Psoriatic arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sarkis Clinical Trials - Ocala /ID# 267840Ocala, FL
Grand Teton Research Group /ID# 267521Idaho Falls, ID
The University of Chicago DCAM /ID# 256577Chicago, IL
Univ Kansas Med Ctr /ID# 262551Kansas City, KS
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022]Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease.
Risankizumab-rzaa: A New Therapeutic Option for the Treatment of Crohn's Disease. [2023]To review the pharmacologic and clinical profile of risankizumab-rzaa in the treatment of Crohn's disease (CD).
In active Crohn disease, risankizumab increased clinical remission and endoscopic response at 12 wk. [2022]Label="SOURCE CITATION">D'Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399:2015-30. 35644154.
Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. [2022]Risankizumab, an interleukin-23 antibody, demonstrated efficacy and acceptable safety in a phase 2 study of patients with moderate-to-severe refractory Crohn's disease. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study.
Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. [2022]There is a great unmet need for new therapeutics with novel mechanisms of action for patients with Crohn's disease. The ADVANCE and MOTIVATE studies showed that intravenous risankizumab, a selective p19 anti-interleukin (IL)-23 antibody, was efficacious and well tolerated as induction therapy. Here, we report the efficacy and safety of subcutaneous risankizumab as maintenance therapy.
Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023]Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD.
Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system. [2023]Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn's disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associated adverse events (AEs) and characterize the clinical priority through the data mining of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).