Valley Institute of Research | Fort Worth, TX
Status and phase
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About
This is a multicenter, randomized, placebo-controlled 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.
Full description
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 study which consists of 2 treatment phases.
This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.
The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2.
At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded.
Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria in maintenance phase:
Inclusion criteria in LTE phase:
Exclusion Criteria in maintenance phase:
Exclusion criteria for LTE phase:
Primary purpose
Allocation
Interventional model
Masking
1,050 participants in 6 patient groups, including a placebo group
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Central trial contact
Laurence Desroys du Roure, PharmD
Data sourced from clinicaltrials.gov
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