M16-000
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 Incorporating Administrative Change 1 and Amendment 1 and 2
IRAS ID
224923
Contact name
Arthur Kaser
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003191-50
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 19 days
Research summary
Crohn’s Disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may present with symptoms of 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. All patients with CD who have previously completed the M16-006 or M15-991 studies and responded to their treatment may be eligible to participate in this study.
The study has 3 sub-studies and will include approximately 912 patients with CD worldwide.
Sub-study1 is 52 weeks long and looks at how risankizumab works and how safe it is compared to placebo (no medicine) to continue to reduce the symptoms of CD. Approximately 450 patients who responded to risankizumab intravenous doses in a previous study will be re-randomised to one of three different treatments, 2 with risankizumab and one with placebo. Patients who responded to placebo or risankizumab injection doses in a previous study will remain on placebo or risankizumab injection doses. The study is blinded (no one knows what the patient receives). Patients who have a disease flare may qualify for rescue treatment with risankizumab.
Sub-study2 will start after Sub-study1 has completed enrollment. Sub-study2 is 52 weeks long and evaluates the efficacy and safety of two different treatment regimens. Subjects will be blinded at their first visit in order to maintain the blinding from the previous study. Starting from week 8, all subjects will receive open label (the dose is known) risankizumab.
Subjects who complete Sub-study1 or 2 may enter Sub-study3. Sub-study3 is an open label long-term extension study to collect safety information. Subjects will receive risankizumab based on their assignment during Sub-study1 or 2. Sub-study3 will last 220 weeks of individual follow-up or until study is discontinued, whichever is earlier.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0402
Date of REC Opinion
28 Nov 2017
REC opinion
Further Information Favourable Opinion