M16-067 (INSPIRE)
Research type
Research Study
Full title
Clinical Study Protocol M16-067: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
IRAS ID
239603
Contact name
Gareth Parkes
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-004677-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 10 days
Research summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). Patients currently have treatment options for UC such as anti-inflammatory agents (mesalazine or steroids), immunomodulators (azathioprine) and biologic agents (drugs that work by injection to modify the immune response, such as adalimumab, infliximab, vedolizumab, etc), but they aren’t always effective. Risankizumab is an investigational drug being developed to treat patients with inflammatory diseases such as UC. This study will evaluate how well risankizumab works and how safe it is compared to placebo (no medicine) in patients with moderate to severe UC who have failed prior biologics. Around 720 participants at 400 sites worldwide will be included.
In blinded (no one knows what the patient receives) Sub-Study 1, 240 patients will be randomly assigned to receive placebo or risankizumab for 12 weeks intravenously (IV). Patients who do not respond after 12 weeks may have a second treatment period of 12 weeks during which all patients receive risankizumab either IV or subcutaneously (SC - injection under the skin) including patients who received only placebo during the first treatment period.
In Sub-Study 2 around 480 patients will receive either risankizumab or placebo IV for 12 weeks. Administered doses will depend on the results of Sub-Study 1. All non-responders will have a chance to receive risankizumab (IV or SC) for another 12 weeks.
When the blinded part of Sub-Study 2 is completed, additional patients may be enrolled to receive open label drug to ensure an adequate number of responders enter the maintenance study M16-066.
All responders after either 12 or 24 weeks of treatment may enter the 52 week maintenance study M16-066. All non-responders after 24 weeks of treatment will be discontinued.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1184
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion