OLE Study for Brazikumab in Ulcerative Collits- EXPEDITION
Research type
Research Study
Full title
A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
IRAS ID
315786
Contact name
Assia Bensalem
Contact email
Sponsor organisation
Astrazeneca AB
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2021-001644-10, EudraCT number
Duration of Study in the UK
3 years, 0 months, 13 days
Research summary
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disorder of the colonic mucosa, which starts in the rectum and generally extends proximally in a continuous manner through part of, or the entire, colon. Bloody diarrhoea is the characteristic symptom of UC, with prominent symptoms of rectal urgency and tenesmus. Many patients, however, have an inadequate response or loss of response over time to UC medications, hence an unmet need for effective therapies with novel mechanisms of action remains.
Brazikumab (an investigational drug not yet approved for use in the UK) is being developed to reduce intestinal inflammation and improve symptoms.
The purpose of this study is to collect long-term safety and effectiveness data from participants with moderately to severely active UC treated with Brazikumab, though limited to participants who previously enrolled in Study D5272C00001 (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 Brazikumab that resulted in discontinuation from Study D5272C00001.
As in this study the sample size of participants is directly correlated with the total number of participants eligible to transition between studies, up to a maximum of 255 participants may enter this study, based on the expected number of participants in Study D5272C00001.
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 to compare different drug doses to evaluate safety and efficacy of Brazikumab in reducing UC symptoms. There will be a total of 17 study visits over a period of approximately 70 weeks. Additional visits may be scheduled for safety reasons. Participation is voluntary and before any study procedures, Informed Consent will be required.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0436
Date of REC Opinion
6 Jan 2023
REC opinion
Further Information Favourable Opinion