This is a multicenter, randomized study to evaluate the long-term efficacy and safety of
ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with
moderately to severely active ulcerative colitis who have inadequate response, no response, a
loss of response, or an intolerance to either conventional therapies [corticosteroids,
immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced
therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor
modulators, and/or JAK inhibitors].
This study is the maintenance phase of both previous induction studies ABX464-105 and
ABX464-106.
All eligible subjects who have completed either one of the induction studies above mentioned,
will be given the opportunity to take part in the present ABX464-107 maintenance study and
will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated
to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical
response at the end of induction.
This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in
the End of Study (EOS) visit.