Phase 2 Dose-finding UC Study
Research type
Research Study
Full title
A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis
IRAS ID
260266
Contact name
Andrea Sawdon
Contact email
Eudract number
2018-001605-93
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
137684, IND
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
The purpose of this study is to look into the safety and efficacy (how well a drug works) of a drug called Brazikumab in the treatment of Ulcerative colitis (UC).UC is a form of inflammatory bowel disease (IBD). Brazikumab (an investigational drug not yet approved for use in UK) is being developed as a treatment for IBD to reduce intestinal inflammation and improve signs and symptoms.
This study will compare Brazikumab with Placebo and with Entyvio/Vedolizumab to evaluate the safety and efficacy of Brazikumab in improving UC symptoms and maintaining that improvement over time. Placebo is a medically inactive solution that looks like Brazikumab but does not contain any active medication. Entyvio is a medication that is approved and available for UC treatment in UK.
Approx 900 adults from 200 sites will participate.
There will be a total of 19 study visits over a period of approx 73 weeks. Additional unscheduled visits may be needed for safety or other reasons.
The study will consist of 4 periods:
• Screening period; to check if you meet the requirements to take part in this study.
• Induction period; you will be assigned to receive either Brazikumab, Entyvio and or Placebo.
• Maintenance period; during this time, you will continue to receive the study medication and the study team will continue to monitor your UC symptoms and general health. The study doctor will also look to see if the study medication has resulted in less severe symptoms since the induction period.
• Safety follow-up; during this time you will not receive any study medication, however the study team will continue to check your health and UC symptoms.
Before any study procedures are undertaken Informed Consent will be required.
At scheduled study visits, participants will visit the research site (NHS or private clinic) where study assessments will take place e.g. physical exam, blood tests, endoscopy, and biopsy.
Participation is voluntary.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0204
Date of REC Opinion
1 Jul 2019
REC opinion
Further Information Favourable Opinion