I6T-MC-AMBZ Mirikizumab - UC
Research type
Research Study
Full title
A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and its Relationship with Other Outcome Measures in Adults with Moderately to Severely Active Ulcerative Colitis Treated with Mirikizumab
IRAS ID
1007423
Contact name
Lucie Libert
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2022-502393-16
Clinicaltrials.gov Identifier
Research summary
A study into Bowel urgency related to Ulcerative Colitis (UC). This study has been designed to find out if the study medication mirikizumab alone can help adult patients with bowel urgency and other symptoms of UC, when compared with other standard treatments already used for bowel urgency and other symptoms of UC. The hope is that the results of this study will help to answer the following research question(s):
• How mirikizumab may affect bowel urgency and other symptoms of UC.
• Whether improvements in bowel urgency are related to changes in other symptoms of UC in people treated with mirikizumab.
The information obtained from this study may help improve the treatment of people with UC in the future.
Various blood, stool and urine samples, as well as intestinal tissue samples, will be collected from patients during this trial.
It will take about up to 36 weeks to complete the whole study, the duration of patients’ participation will depend on how well the disease responds to the study treatment and how many cycles of treatment they receive. Patients will receive treatment until their disease progresses, or if they can’t tolerate the treatment, or if they and/or their doctor wish to stop treatment. After they stop the study treatment, they will be asked to return for follow-up visits for as long as they are still on the study.
The study is divided into 4 separate periods including screening of up to 4 weeks, treatment periods lasting 28 weeks (12 weeks with IV delivery and 16 weeks of injections) and a final follow up period of 8 weeks.
Participants will attend a combination of visits to the study centre (hospital or clinic) and remote visits from home.
Some participants will be invited to participate in an optional continued access period. This is to provide eligible participants of Study AMBZ continued access to mirikizumab until the time that mirikizumab is approved and available for the treatment of UC in the countries in which they reside.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0106
Date of REC Opinion
13 Sep 2023
REC opinion
Further Information Favourable Opinion