ABTECT - Maintenance

NCT05535946
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,116
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Lead sponsor
Abivax S.A.
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Start date
2023-01-16
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Number of sites
413
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
ABTECT - Maintenance
clinicaltrials.gov
Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-05-01
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First posted
2022-09-10
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Registry last updated
2026-07-07
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Primary completion date
2026-04-28
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Start date
2023-01-16
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Actual participants
1,116
clinicaltrials.gov
Participants
1,116
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
4
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Number of sites
413
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Abivax S.A.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05535946
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ClinicalTrials.gov ID
NCT05535946
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masking description
All eligible subjects will be randomized to either the double blind, placebo-controlled Part #1 (ABX464 50mg or 25mg or placebo) or randomized to double-blind Part #2 (ABX464 50mg or 25mg) depending on their clinical response at the end of induction.
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Rate of subjects in clinical remission at Week 44

    Timeframe: 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.

  2. Number and percentage of all treatment-emergent adverse events (TEAEs)

    Timeframe: Week 44

    The Part 2 primary objective is safety

  3. Number and percentage of all serious adverse events (SAEs)

    Timeframe: Week 44

    The Part 2 primary objective is safety

  4. Number and percentage of all causally related TEAEs/SAEs

    Timeframe: Week 44

    The Part 2 primary objective is safety

  1. Proportion of subjects with endoscopic improvement at Week 44

    Timeframe: Week 44

    To compare the efficacy of ABX464 versus placebo on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44

  2. Proportion of subjects with corticosteroid-free clinical remission

    Timeframe: 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)

  3. Proportion of subjects with sustained clinical remission at Week 44

    Timeframe: Week 44

    To compare the efficacy of ABX464 versus placebo to sustain clinical remission at Week 44

  4. Proportion of subjects with HEMI per Geboes scoring at Week 44

    Timeframe: Week 44

    To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo at Week 44

  5. Proportion of subjects with endoscopic remission at Week 44

    Timeframe: Week 44

    To compare the efficacy of ABX464 versus placebo on endoscopic remission (MES = 0) at Week 44

  6. LTE Phase - Proportion of subjects in clinical remission at Year 1

    Timeframe: 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

  7. LTE Phase - Proportion of subjects in clinical remission at Year 4

    Timeframe: 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

  8. LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry

    Timeframe: 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)

  9. LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry)

    Timeframe: 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)

  10. LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1

    Timeframe: LTE Year 1

    To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)

  11. LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4

    Timeframe: LTE Year 4

    To evaluate the efficacy of obefazimod on endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1)

  12. LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1

    Timeframe: LTE year 1

    To evaluate the efficacy of obefazimod on endoscopic remission ((Mayo Endoscopic Subscore (MES) = 0)

  13. LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4

    Timeframe: LTE year 4

    To evaluate the efficacy of obefazimod on endoscopic remission (Mayo Endoscopic Subscore (MES) = 0)

  14. LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit

    Timeframe: 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)

  15. LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1

    Timeframe: LTE Year 1

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring

  16. LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4

    Timeframe: LTE Year 4

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal improvement (HEMI) per Geboes scoring

  17. LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1

    Timeframe: LTE Year 1

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo

  18. LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4

    Timeframe: LTE Year 4

    To evaluate the efficacy of obefazimod on histologic endoscopic mucosal remission (HEMR) versus placebo

  19. 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

    Timeframe: 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.

  20. 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

    Timeframe: 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.

  21. 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

    Timeframe: LTE Year 1

    To evaluate the efficacy of obefazimod on sustained endoscopic improvement

  22. 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

    Timeframe: LTE year 4

    To evaluate the efficacy of obefazimod on sustained endoscopic improvement

  23. LTE Phase - Proportion of subjects with symptomatic remission by visit

    Timeframe: 4 years

    To evaluate the efficacy of obefazimod on symptomatic remission (SFS = 0 or 1 and RBS = 0) by visit (every 3-month)

  24. LTE Phase - Proportion of subjects with sustained symptomatic remission by visit

    Timeframe: 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

  25. LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1

    Timeframe: 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)

And 1 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
16 Years
Healthy volunteers
No

Inclusion Criteria in maintenance phase:

  • 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

Inclusion criteria in LTE phase:

  • 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 in maintenance phase:

  • 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.

Exclusion criteria for LTE phase:

  • 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).
Sources for eligibility
clinicaltrials.gov

  • Digestive Health Specialists of the SoutheastDothan, United States
  • Research Solutions of Arizona, PCLitchfield Park, United States
  • GI AllianceSun City, United States
  • University of ArizonaTucson, United States
  • University of Arkansas for Medical SciencesLittle Rock, United States
  • Citrus Valley GastroenterologyCovina, United States
  • University of California (San Diego)La Jolla, United States
  • United Medical DoctorsMurrieta, United States
  • California Medical Research Associates Inc.Northridge, United States
  • Clinnova Research SolutionsOrange, United States
  • Clinical Applications LaboratoriesSan Diego, United States
  • Kaiser Foundation Research Institute, a Division of Kaiser Permanente HospitalsAurora, United States
  • Danbury HospitalDanbury, United States
  • West Central Gastroenterology d/b/a Gastro FloridaClearwater, United States
  • Nature Coast Clinical Research, LLCInverness, United States
  • Auzmer ResearchLakeland, United States
  • Infinite Clinical Research IncMiami, United States
  • Research Associates of South Florida, LLCMiami, United States
  • University of MiamiMiami, United States
  • MedOne Clinical Research LLCMiami, United States
  • Nicklaus Children's HospitalMiami, United States
  • Medical Professional Clinical Research CenterMiami, United States
  • Wellness Clinical ResearchMiami Lakes, United States
  • Ocala GI ResearchOcala, United States
  • Arnold Palmer Hospital For ChildrenOrlando, United States

And 388 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)