M15-722 Phase IIa, ABBV-323 in subjects with UC

• Research type

  Research Study

• Full title

  M15-722: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

• IRAS ID

  252050

• Contact name

  Dr John Paul Seenan

• Contact email

  johnpaul.seenan@nhs.net

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2018-000930-37

• Duration of Study in the UK

  4 years, 10 months, 21 days

• Research summary

  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 (drugs such as azathioprine that work to modify the immune response) and biologic agents (injected drugs such as adalimumab, certolizumab pegol, and infliximab that modify the immune response), but they aren’t always effective.
  ABBV-323 is an investigational drug being developed to help treat patients with inflammatory diseases such as UC. This study will evaluate how well ABBV-323 works within the body and how safe it is compared to Placebo (dummy drug) in patients with moderate to severe UC who have failed prior treatment. Around 60 participants at 40 sites worldwide will be included.
  The study comprises two parts, Induction and Maintenance. In the Induction period, patients will receive either ABBV-323 or Placebo for 12 weeks (over 6 study visits). The drug will be injected intravenously (straight into the veins) and subcutaneously (into tissue).The second part of the study is called the Maintenance period. This part is open-label (where the patient knows what drug they are getting). ABBV-323 will be subcutaneously injected every other week up to week 50.

  At week 8 and 52, patients will undergo an endoscopy (a clinical procedure where a camera is used to look at the bowel) to evaluate whether the patient is in remission (symptom free). Patients who complete the study will have a follow up phone call after 84 days (from taking the study drug) to check their progress.

  Summary of results:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.abbvieclinicaltrials.com%252Fstudy%252F%253Fid%253DM15-722%2FNBTI%2Fb4S4AQ%2FAQ%2F544a76d5-4770-432f-a75e-fddd2a2f2dc9%2F2%2F-05YI4Bi3Q&data=05%7C02%7Coxfordb.rec%40hra.nhs.uk%7C7fd7cb36d9a342d5991008dce6b9ffb4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638638933744330399%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=RPr4wbmf1nqhW29Ig3mz0nSZHr7FIV%2F%2BxUQLv2lbu4o%3D&reserved=0

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  18/SC/0598

• Date of REC Opinion

  3 Jan 2019

• REC opinion

  Further Information Favourable Opinion