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ABTECT - Maintenance

PHASE3RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.
  • Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
  • Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
  • Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with contraception requirements as described in Section 4.4. (Contraception) of the protocol.
  • Subjects must be able and willing to comply with study visits and procedures as per protocol.
  • Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.
  • Subject must have completed the maintenance phase.
  • Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study.
  • Exclusion criteria

  • Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
  • Subjects who have developed any major illness/condition (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
  • Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject if he or she participates in the study.
  • Subjects who plan to participate in other investigational studies during the maintenance study.
  • Male or female planning a pregnancy, or pregnant female subjects.
  • Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
  • Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
  • Subject who is planning to receive live vaccine during the study.
  • Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Subject continues to satisfy exclusion criteria listed above for the maintenance phase.
  • Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
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    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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    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

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    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/ArmIntervention/Treatment
    PLACEBO_COMPARATOR: ABX464 50mg - Responder subjects at the end of induction
    • Subjects will be orally dosed during 44 weeks
    DRUG: ABX464
    • Administered once daily, preferably in the morning, with food
    PLACEBO_COMPARATOR: ABX464 25mg - Responder subjects at the end of induction
    • Subjects will be orally dosed during 44 weeks
    DRUG: ABX464
    • Administered once daily, preferably in the morning, with food
    PLACEBO_COMPARATOR: Placebo - Responder subjects at the end of induction
    • Subjects will be orally dosed during 44 weeks
    DRUG: Placebo
    • Administered once daily, preferably in the morning, with food
    EXPERIMENTAL: ABX464 50mg - Non responder subjects at the end of induction
    • Subjects will be orally dosed during 44 weeks
    DRUG: ABX464
    • Administered once daily, preferably in the morning, with food
    EXPERIMENTAL: ABX464 25mg - Non responder subjects at the end of induction
    • Subjects will be orally dosed during 44 weeks
    DRUG: ABX464
    • Administered once daily, preferably in the morning, with food
    EXPERIMENTAL: 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.
    DRUG: ABX464
    • Administered once daily, preferably in the morning, with food

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Rate of subjects in clinical remission at Week 44The 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 safetyWeek 44
    Number and percentage of all serious adverse events (SAEs)The Part 2 primary objective is safetyWeek 44
    Number and percentage of all causally related TEAEs/SAEsThe Part 2 primary objective is safetyWeek 44

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Proportion of subjects with endoscopic improvement at Week 44To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44Week 44
    Proportion of subjects with corticosteroid-free clinical remissionTo 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 44To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44Week 44
    Proportion of subjects with HEMI per Geboes scoring at Week 44To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44Week 44
    Proportion of subjects with endoscopic remission at Week 44To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44Week 44
    LTE Phase - Proportion of subjects in clinical remission at Year 1To evaluate the efficacy of obefazimod on clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Year 1LTE Year 1
    LTE Phase - Proportion of subjects in clinical remission at Year 4To evaluate the efficacy of obefazimod on clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Year 4LTE Year 4
    LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entryTo 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 1To 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 4To 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 1To 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 4To 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 visitTo 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 1To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoringLTE Year 1
    LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoringLTE Year 4
    LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placeboLTE Year 1
    LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placeboLTE 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 44To 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 44To 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 44To evaluate the efficacy of obefazimod on sustained endoscopic improvementLTE 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 44To evaluate the efficacy of obefazimod on sustained endoscopic improvementLTE year 4
    LTE Phase - Proportion of subjects with symptomatic remission by visitTo 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 visitTo 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 444 years
    LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1To 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 4To 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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    References

    Clinical Trials Gov: ABTECT - Maintenance

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