M15-991
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
IRAS ID
224915
Contact name
Arthur Kaser
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003190-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 21 days
Research summary
Summary of Research
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever.
Risankizumab is an investigational drug being developed to help treat patients with inflammatory diseases. The study is for patients with moderate to severe CD who failed prior biologic treatment (e.g adalimumab, infliximab, certolizumab pegol, natalizumab, vedolizumab).The study will evaluate how well risankizumab works and how safe it is compared to placebo (no medicine) during induction therapy (an induction therapy is one designed to get the signs and symptoms of the disease under control). It will include approximately 579 patients with CD worldwide.
The study consists of one or two induction periods. The first 12 weeks (Induction Period 1), patients will be randomly assigned to one of three different treatments, 2 with risankizumab (2 different doses) and 1 with placebo (no medicine). The study is blinded (no one knows which treatment a patient receives.)
If at week 12 the treatment has not worked (clinical response not achieved), patients who were on risankizumab will be re-randomised for a further 12 weeks (Induction Period 2) to receive one of three different treatments with risankizumab (three different doses). Patients who were on placebo during Induction Period 1 with no clinical response at week 12 will receive risankizumab (one dose) for another 12 weeks. All patients in Induction Period 2 will also be given a matching placebo to maintain the study blind.
Patients who have achieved a clinical response at week 12 or 24 in the study may be eligible to enter in the maintenance study.
Patients, who did not enter in the maintenance study, will be contacted 105 days from the last treatment received to obtain information on any side effects.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0401
Date of REC Opinion
28 Nov 2017
REC opinion
Further Information Favourable Opinion