M16-006
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind,Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease
IRAS ID
224645
Contact name
Arthur Kaser
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003123-32
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 couldn’t tolerate or didn’t respond to conventional or biologic CD therapies. The study is evaluating the efficacy and safety of risankizumab versus placebo (no medicine) as an induction therapy (an induction therapy is one designed to get the signs and symptoms of the disease under control). The study will include approximately 940 patients with CD worldwide.
The study consists of one or two induction periods and may last up to 40 weeks.
The first 12 weeks (Induction 1) patients will be randomised to one of three different treatments, 2 with risankizumab (2 different doses) and 1 with placebo. The study is blinded (no one knows what 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 2) to receive one of three different treatments with risankizumab (at three different doses). Patients who were on the placebo in Induction 1 with no clinical response at week 12 will receive risankizumab (one dose) for another 12 weeks. All patients in Induction 2 will 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.Summary of Results
The study was completed as planned. The main goal of the study was to see how patients with moderate to severe CD responded to risankizumab or placebo after 12 weeks of treatment and what percentage of patients showed a response to treatment.
Response to treatment was based on Crohn’s disease activity index (CDAI), the stool frequency and abdominal pain score (SF/APS) (used to evaluate clinical remission), and an endoscopy score (used to evaluate endoscopic response)
Clinical remission is when the CD symptoms are gone or mostly gone. Endoscopic response is when the bowels appear healed when seen on endoscopy.
The CDAI measures CD symptoms such as abdominal pain, wellbeing, complications, and weight change.
The SF/AP score records the number of daily loose or watery stools and abdominal pain levels.
Endoscopy allows the doctor to see the inside of the bowels by inserting a long flexible tube into the rectum with a tiny video camera.
At the end of Part 1, this study showed that patients treated with risankizumab had better improvement in their CD symptoms compared to patients treated with placebo.
SF/AP clinical remission was achieved by:
21.7% of patients treated with placebo.
43.5% of patients treated with risankizumab 600mg.
41.0% of patients treated with risankizumab 1200mg.
CDAI clinical remission was achieved by:
24.6% of patients treated with placebo.
45.2% of patients treated with risankizumab 600mg.
41.6% of patients treated with risankizumab 1200mg.
Endoscopic response was achieved by:
12.0% of patients treated with placebo.
40.3% of patients treated with risankizumab 600mg.
32.1% of patients treated with risankizumab 1200mg.
Treatment with risankizumab in Part 1 with continued treatment in Part 2 was safe and well-tolerated. Side effects were similar across all treatment groups.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0400
Date of REC Opinion
28 Nov 2017
REC opinion
Further Information Favourable Opinion