M16-066 (COMMAND)

• Research type

  Research Study

• Full title

  Clinical Study Protocol M16-066: 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 Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

• IRAS ID

  239614

• Contact name

  Gareth Parkes

• Contact email

  gareth.parkes@bartshealth.nhs.uk

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2016-004676-22

• Clinicaltrials.gov Identifier

  NCT03398135

• Duration of Study in the UK

  4 years, 11 months, 25 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: 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). This is a 52 week maintenance study and an open-label (the dose is known) long-term extension study in patients with moderate to severe UC who responded to induction treatment in studies M16-067 and M16-065.

  Around 760 participants at 400 sites worldwide will be included.

  In blinded (no one knows what the patient receives) Sub-Study 1 patients receive risankizumab or placebo subcutaneously (SC - injection under the skin ) once every 8 weeks for 52 weeks (Q8W); Patients have the possibility of receiving rescue risankizumab if required.

  In Sub-Study 2 patients will receive placebo intravenously (IV) and risankizumab SC or risankizumab IV and placebo SC at the first visit. All subjects will then receive risankizumab SC at week 8 with a possibility of having risankizumab rescue IV if required.

  All patients who complete Sub-Study 1 and 2 may continue into the long-term extension Sub-Study 3 and will receive risankizumab Q8W.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  18/LO/1185

• Date of REC Opinion

  24 Dec 2018

• REC opinion

  Further Information Favourable Opinion