OLE of Brazikumab in Moderately/Severely Active CDs-INTREPID OLE
Research type
Research Study
Full title
An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE)
IRAS ID
299171
Contact name
Nigel Trudgill
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-001866-14
Duration of Study in the UK
2 years, 5 months, 7 days
Research summary
Crohn's disease (CD) is a chronic disease (form of inflammatory bowel disease) in which parts of the digestive system become inflamed. The most common symptoms are abdominal pain, diarrhoea, tiredness and loss of appetite. CD affects at least 115,000 people in the UK. Despite the availability of treatments, there is still
a need for novel therapies for the treatment of CD due to the evidence that not all patients will respond
or maintain their response to the available treatment options. Brazikumab (an investigational drug not yet approved for use in UK) is being developed as a treatment for CD to reduce intestinal inflammation and improve signs and symptoms.
The purpose of this study is to collect long-term safety and effectiveness (how well drug works) data from participants with moderately to severely active Crohn’s Disease treated with Brazikumab, though limited to participants who previously enrolled in Study D5271C00001 (investigating the same drug).
Participants are permitted to join this study only if they continue to meet eligibility criteria and have not had adverse experiences considered to be related to study medication that resulted in discontinuation of the initial lead-in study intervention.
The study will consist of a 52-week open-label treatment period and an 18-week safety follow-up period, for a total of up to 70 weeks. Participants will be divided into two groups (low dose brazikumab, high dose brazikumab). There will be a total of 17 separate study visits over a period of approximately 70 weeks.
Additional visits may be scheduled for safety reasons. At scheduled study visits, participants will visit the research site (NHS or private clinic) where study assessments take place eg. Physical exams, endoscopies or blood tests.
Participation is voluntary and before any study procedures are undertaken Informed Consent will be required.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0346
Date of REC Opinion
15 Sep 2022
REC opinion
Further Information Favourable Opinion