Crohn’s disease: Study on the efficacy and safety of risankizumab (FORTIFY)

ClinicalTrials.gov ID: NCT03105102
Sponsor: AbbVie

Official title:
A multicenter, randomized, double-blind, placebo-controlled 52-week maintenance study with open-label long-term extension to evaluate the efficacy and safety of risankizumab in patients with Crohn’s disease.

Study overview:
The study consists of four sub-studies:

  • Sub-study 1: Randomized, double-blind, placebo-controlled maintenance study in patients who have responded to intravenous risankizumab induction
  • Sub-study 2: Randomized, exploratory study with two dosage regimens
  • Sub-study 3: Open-label long-term extension study to investigate long-term safety, efficacy and tolerability
  • Sub-study 4: Open-label study with On-Body-Injector (OBI) to evaluate patient-reported outcomes, efficacy, safety, tolerability and pharmacokinetics

In addition, an open-label continuous treatment extension (OL CTE) to ensure an uninterrupted supply until risankizumab is commercially available.