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ABTECT - Maintenance
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 16 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-01-16
Primary completion: 2026-01-01
Study completion finish: 2030-01-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05535946
Intervention or treatment
DRUG: ABX464
DRUG: Placebo
Conditions
- • Ulcerative Colitis
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
PLACEBO_COMPARATOR: ABX464 50mg - Responder subjects at the end of induction
| DRUG: ABX464
|
PLACEBO_COMPARATOR: ABX464 25mg - Responder subjects at the end of induction
| DRUG: ABX464
|
PLACEBO_COMPARATOR: Placebo - Responder subjects at the end of induction
| DRUG: Placebo
|
EXPERIMENTAL: ABX464 50mg - Non responder subjects at the end of induction
| DRUG: ABX464
|
EXPERIMENTAL: ABX464 25mg - Non responder subjects at the end of induction
| DRUG: ABX464
|
EXPERIMENTAL: Long Term Extension
| DRUG: ABX464
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Rate of subjects in clinical remission at 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. | Week 44 |
Number and percentage of all treatment-emergent adverse events (TEAEs) | The Part 2 primary objective is safety | Week 44 |
Number and percentage of all serious adverse events (SAEs) | The Part 2 primary objective is safety | Week 44 |
Number and percentage of all causally related TEAEs/SAEs | The Part 2 primary objective is safety | Week 44 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Proportion of subjects with endoscopic improvement at Week 44 | To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44 | Week 44 |
Proportion of subjects with corticosteroid-free clinical remission | 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) | Week 44 |
Proportion of subjects with sustained clinical remission at Week 44 | To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44 | Week 44 |
Proportion of subjects with HEMI per Geboes scoring at Week 44 | To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44 | Week 44 |
Proportion of subjects with endoscopic remission at Week 44 | To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44 | Week 44 |
LTE Phase - Proportion of subjects in clinical remission at 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 Year 1 |
LTE Phase - Proportion of subjects in clinical remission at 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 Year 4 |
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry | 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 Year 1 |
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry) | 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 Year 4 |
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1 | To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) | LTE Year 1 |
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4 | To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) | LTE Year 4 |
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1 | To evaluate the efficacy of obefazimod on endoscopic remission ((Mayo Endoscopic Subscore (MES) = 0) | LTE year 1 |
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4 | To evaluate the efficacy of obefazimod on endoscopic remission (Mayo Endoscopic Subscore (MES) = 0) | LTE year 4 |
LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit | 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) | 4 years |
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1 | To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring | LTE Year 1 |
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4 | To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring | LTE Year 4 |
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1 | To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo | LTE Year 1 |
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4 | To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo | 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 | 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 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 | 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 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 | To evaluate the efficacy of obefazimod on sustained endoscopic improvement | 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 | To evaluate the efficacy of obefazimod on sustained endoscopic improvement | LTE year 4 |
LTE Phase - Proportion of subjects with symptomatic remission by visit | To evaluate the efficacy of obefazimod on symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month) | 4 years |
LTE Phase - Proportion of subjects with sustained symptomatic remission by visit | 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 | 4 years |
LTE Phase - Proportion of subjects with CS-free clinical remission at 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 Year 1 |
LTE Phase - Proportion of subjects with CS-free clinical remission at 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) | LTE Year 4 |
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