ABTECT - Maintenance
- Registration Number
- NCT05535946
- Lead Sponsor
- Abivax S.A.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1050
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABX464 25mg - Non responder subjects at the end of induction ABX464 Subjects will be orally dosed during 44 weeks Long Term Extension ABX464 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. ABX464 50mg - Responder subjects at the end of induction ABX464 Subjects will be orally dosed during 44 weeks ABX464 25mg - Responder subjects at the end of induction ABX464 Subjects will be orally dosed during 44 weeks Placebo - Responder subjects at the end of induction Placebo Subjects will be orally dosed during 44 weeks ABX464 50mg - Non responder subjects at the end of induction ABX464 Subjects will be orally dosed during 44 weeks
- Primary Outcome Measures
Name Time Method Number and percentage of all causally related TEAEs/SAEs Week 44 The Part 2 primary objective is safety
Rate of subjects in clinical remission at Week 44 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) Week 44 The Part 2 primary objective is safety
Number and percentage of all serious adverse events (SAEs) Week 44 The Part 2 primary objective is safety
- Secondary Outcome Measures
Name Time Method Proportion of subjects with endoscopic improvement at Week 44 Week 44 To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44
Proportion of subjects with corticosteroid-free clinical remission Week 44 To compare the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission (clinical remission at Week 44 and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry)
Proportion of subjects with sustained clinical remission at Week 44 Week 44 To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44
Proportion of subjects with HEMI per Geboes scoring at Week 44 Week 44 To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44
Proportion of subjects with endoscopic remission at Week 44 Week 44 To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44
LTE Phase - Proportion of subjects in clinical remission at Year 1 LTE Year 1 To evaluate the efficacy of obefazimod on clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Year 1
LTE Phase - Proportion of subjects in clinical remission at Year 4 LTE Year 4 To evaluate the efficacy of obefazimod on clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Year 4
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry LTE Year 1 To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and corticosteroid free for at least 12 weeks prior to Year 1 in the subpopulation with corticosteroids at maintenance study entry)
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry) LTE Year 4 To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and corticosteroid free for at least 12 weeks prior to Year 4 in the subpopulation with corticosteroids at maintenance study entry)
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1 LTE Year 1 To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4 LTE Year 4 To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1 LTE year 1 To evaluate the efficacy of obefazimod on endoscopic remission ((Mayo Endoscopic Subscore (MES) = 0)
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4 LTE year 4 To evaluate the efficacy of obefazimod on endoscopic remission (Mayo Endoscopic Subscore (MES) = 0)
LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit 4 years To evaluate the efficacy of obefazimod on CS-free symptomatic remission (symptomatic remission (SFS = 0 or 1 and RBS = 0) and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry) by visit (every 3-month)
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1 LTE Year 1 To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4 LTE Year 4 To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1 LTE Year 1 To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4 LTE Year 4 To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo
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 To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.
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 To evaluate the efficacy of obefazimod on sustained clinical remission Sustained clinical remission for the LTE is defined as clinical remission assessed at an endoscopy visit during the LTE in the sub-population of subjects in clinical remission at Week 44.
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 To evaluate the efficacy of obefazimod on sustained endoscopic improvement
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 To evaluate the efficacy of obefazimod on sustained endoscopic improvement
LTE Phase - Proportion of subjects with symptomatic remission by visit 4 years To evaluate the efficacy of obefazimod on symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month)
LTE Phase - Proportion of subjects with sustained symptomatic remission by visit 4 years To evaluate the efficacy of obefazimod on sustained symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month), in the sub-population of subjects with symptomatic remission at Week 44
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1 LTE Year 1 To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 1 and CS-free for at least 12 weeks immediately prior to Year 1)
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 4 LTE Year 4 To evaluate the efficacy of obefazimod on CS-free clinical remission (clinical remission at Year 4 and CS-free for at least 12 weeks immediately prior to Year 4)
Trial Locations
- Locations (550)
University of Alabama -Birmingham
🇺🇸Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Lakeview Clinical Research
🇺🇸Guntersville, Alabama, United States
Research Solutions of Arizona, PC
🇺🇸Litchfield Park, Arizona, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
GI Alliance
🇺🇸Gurnee, Illinois, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Scroll for more (540 remaining)University of Alabama -Birmingham🇺🇸Birmingham, Alabama, United StatesKirk Russ, MDContact