AMAM; Mirikizumab in adults with mod-to-severe active crohns disease

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease

• IRAS ID

  264684

• Contact name

  Rosemary Derbyshire

• Contact email

  derbyshire_rosemary_e@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2018-004614-18

• Clinicaltrials.gov Identifier

  NCT03926130

• Clinicaltrials.gov Identifier

  EudraCT number, 2018-004614-18

• Duration of Study in the UK

  2 years, 8 months, 22 days

• Research summary

  Crohn’s disease (CD) is a chronic inflammatory condition of the gastrointestinal tract (GI) that can affect any part of the GI tract from the mouth to the anus. It is a progressive disease that usually starts with mild symptoms and gradually gets worse. Symptoms include chronic diarrhoea, abdominal pain, weight loss, fever, fatigue, anaemia and rectal bleeding. Symptoms may be constant or may flare-up every few weeks or months. Severe CD may disrupt a patients’ daily life due to constant pain, discomfort and need to use the bathroom.
  There is no cure for CD. The main treatments are medicines that reduce inflammation in the digestive system, medicines that stop the inflammation returning or surgery to remove a small part of the digestive system. A sizable proportion of patients with moderately to severely active CD have an inadequate response to, loss of response to, or intolerance to conventional or biologic therapy for CD. This cohort of patients will be eligible for study AMAM.
  Mirikizumab (the study drug) is a monoclonal antibody designed to suppress the activity of IL23 in the CD pathway and therefore reduce inflammation. In a previous study of patients with moderately to severely active CD, mirikizumab showed clinically relevant and consistent treatment effect in reducing or resolving inflammation in the GI tract and patient-reported symptoms.
  The purpose of study AMAM is to evaluate the safety and efficacy of mirikizumab in achieving endoscopic and clinical outcomes up to Week 52 in patients with moderately to severely active CD. Participants will be randomized in a 6:3:2 ratio to receive mirikizumab, ustekinumab or placebo, respectively. Study assessments include physical examinations relating to CD, ECGs, blood, urine and stool tests, questionnaires, endoscopies and biopsies. Participants will receive treatment for 52 weeks, with a maximum study participation of 72 weeks.

  LAY SUMMARY OF STUDY RESULTS:
  A lay summary of study results is not available at this time, but will be provided for publication when available. https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03926130%253Ftab%253Dresults%2FNBTI%2FYmDBAQ%2FAQ%2F8f733e07-59af-4f37-a34e-98008ca1fd5d%2F2%2F3kP-0x5EG-&data=05%7C02%7Ccoventryandwarwick.rec%40hra.nhs.uk%7Cb8eb315f00b945d58cef08de238e2bbc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638987290691735198%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=8GR9Ngtxw8Av2rqZrKVIVgwnGYbgFhoSUQfKDEFUMJo%3D&reserved=0

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  19/WM/0206

• Date of REC Opinion

  16 Sep 2019

• REC opinion

  Further Information Favourable Opinion