A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Overview
- Phase
- Phase 3
- Intervention
- ABX464
- Conditions
- Ulcerative Colitis
- Sponsor
- Abivax S.A.
- Enrollment
- 1116
- Locations
- 550
- Primary Endpoint
- Number and percentage of all causally related TEAEs/SAEs
- Status
- Active, Not Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ABX464 50mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Intervention: ABX464
ABX464 25mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Intervention: ABX464
Placebo - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Intervention: Placebo
ABX464 50mg - Non responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Intervention: ABX464
ABX464 25mg - Non responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
Intervention: ABX464
Long Term Extension
At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.
Intervention: ABX464
Outcomes
Primary Outcomes
Number and percentage of all causally related TEAEs/SAEs
Time Frame: Week 44
The Part 2 primary objective is safety
Rate of subjects in clinical remission at Week 44
Time Frame: Week 44
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Week 44.
Number and percentage of all treatment-emergent adverse events (TEAEs)
Time Frame: Week 44
The Part 2 primary objective is safety
Number and percentage of all serious adverse events (SAEs)
Time Frame: Week 44
The Part 2 primary objective is safety
Secondary Outcomes
- Proportion of subjects with endoscopic improvement at Week 44(Week 44)
- Proportion of subjects with corticosteroid-free clinical remission(Week 44)
- Proportion of subjects with sustained clinical remission at Week 44(Week 44)
- Proportion of subjects with HEMI per Geboes scoring at Week 44(Week 44)
- Proportion of subjects with endoscopic remission at Week 44(Week 44)
- LTE Phase - Proportion of subjects in clinical remission at Year 1(LTE Year 1)
- LTE Phase - Proportion of subjects in clinical remission at Year 4(LTE Year 4)
- LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry(LTE Year 1)
- LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry)(LTE Year 4)
- LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1(LTE Year 1)
- LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4(LTE Year 4)
- LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1(LTE year 1)
- LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4(LTE year 4)
- LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit(4 years)
- LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1(LTE Year 1)
- LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4(LTE Year 4)
- LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1(LTE Year 1)
- LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4(LTE Year 4)
- LTE Phase - Proportion of subjects with sustained clinical remission at LTE Year 1, in the sub-population of subjects with clinical remission at Week 44(LTE Year 1)
- LTE Phase - Proportion of subjects with sustained clinical remission at LTE year 4, in the sub-population of subjects with clinical remission at Week 44(LTE year 4)
- LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 1, in the sub-population of subjects with endoscopic improvement at Week 44(LTE Year 1)
- LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 4, in the sub-population of subjects with endoscopic improvement at Week 44(LTE year 4)
- LTE Phase - Proportion of subjects with symptomatic remission by visit(4 years)
- LTE Phase - Proportion of subjects with sustained symptomatic remission by visit(4 years)
- LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1(LTE Year 1)
- LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 4(LTE Year 4)