VIVID-2; A Phase 3 Extension Study of Mirikizumab in Patients with Crohn's Disease
Research type
Research Study
Full title
A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease
IRAS ID
1004264
Contact name
Marcia Vowles
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-002687-27
Clinicaltrials.gov Identifier
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 can 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 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. Mirikizumab (the study drug) is a monoclonal antibody designed to suppress the activity of IL23 in the CD pathway and therefore reduce inflammation.
AMAX is a long-term study to evaluate how safe and effective mirikizumab may be. Approximately 640 to 900 patients with moderately to severely active CD will be enrolled globally who have participated in a prior mirikizumab CD study, AMAM. In AMAX, all patients will receive mirikizumab subcutaneously (SC) for a duration of 3 years, or until mirikizumab is commercially available in the country in which the patient resides, whichever occurs first. All patients may remain in AMAX as long as mirikizumab is tolerated with no safety concerns and, in the opinion of their study doctor, the patient is benefitting from the study drug.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0039
Date of REC Opinion
30 Mar 2022
REC opinion
Further Information Favourable Opinion