ABX464-103 A Phase IIb study of ABX464 in Ulcerative Colitis patients.
Research type
Research Study
Full title
A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
IRAS ID
269984
Contact name
Jimmy Limdi
Contact email
Sponsor organisation
ABIVAX
Eudract number
2018-003558-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Ulcerative colitis (UC) is a lifelong inflammatory disease of the large intestine, also known as the colon. The cause of this inflammation is not known and there is currently no permanent cure available. Current treatment of Ulcerative colitis consists mainly of treatments that can suppress the inflammation of the colon and allow for tissues to heal. However, for many patients with moderate to severely active ulcerative colitis, currently available treatment is not effective and there is need for newer and effective treatment options.
ABX464 is an experimental medicine with a new mechanism of action reducing this inflammation of the colon. This research study aims to assess the efficacy of different doses of ABX464 in controlling the inflammation and therefore the symptoms of disease in order to determine the optimal dose of the study drug ABX464. The study will also assess how different doses of ABX464 is tolerated by patients.
Participants of the study will be adult patients with moderate to severe active UC who meet all of the inclusion criteria and none of the exclusion criteria as described in the protocol.
Approximately 232 patients will be randomised in this study across 110 to 150 sites in Europe, Canada and potentially the USA.
Participants on the study will be randomised into 4 parallel intervention/treatment groups and will be treated for 16 Weeks. At Week 16, participants willing to continue the study treatment will be eligible for enrolment in an Open Label Extension study (ABX464-104).REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1932
Date of REC Opinion
11 Feb 2020
REC opinion
Further Information Favourable Opinion