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ABTECT - Maintenance

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ClinicalTrials.gov Identifier: NCT05535946
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Abivax S.A.

Study Description
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Brief Summary:

This is a multicenter, randomized 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.

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 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction.

This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: ABX464 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Among both induction studies, subjects assessed as responders will be randomized as follows in the maintenance study according to their induction treatment:

  • ABX464 Dose 50 mg QD
  • ABX464 Dose 25 mg QD (2/3 subjects from the 25mg induction dose group and 1/3 subjects from the 50mg induction group)
  • Placebo (1/3 subjects from the 25mg induction dose group and 2/3 subjects from the 50mg induction group). All subjects with clinical response who were dosed with placebo in the induction studies will be randomized into the placebo group.

Non-responder subjects are expected to opt in the maintenance study part #2 after completion of the induction studies. They will be randomly allocated into the two open-label ABX464 dose levels.

  • ABX464 Dose 50 mg QD
  • ABX464 Dose 25 mg QD
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: All eligible subjects will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction.
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABX464 50mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
 Drug: ABX464
Administered once daily in the morning with food
Other Name: Obefazimod
Experimental: ABX464 25mg - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
 Drug: ABX464
Administered once daily in the morning with food
Other Name: Obefazimod
Placebo Comparator: Placebo - Responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
 Drug: Placebo
Administered once daily 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 in the morning with food
Other Name: Obefazimod
Experimental: ABX464 25mg - Non responder subjects at the end of induction
Subjects will be orally dosed during 44 weeks
 Drug: ABX464
Administered once daily in the morning with food
Other Name: Obefazimod


Outcome Measures
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Primary Outcome Measures :
  1. Rate of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1 (friability is scored as 2)] at Week 44 [ Time Frame: Week 44 ]
    The study primary objective is to evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44.


Secondary Outcome Measures :
  1. Proportion of subjects with endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44 [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 versus placebo on endoscopic improvement.

  2. Proportion of subjects with symptomatic remission (SFS = 0 or 1 and RBS = 0) at Week 44 [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 versus placebo on symptomatic remission

  3. Proportion of subjects with 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) [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission.

  4. Proportion of subjects with sustained clinical remission at Week 44 [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 versus placebo to sustain clinical remission.

  5. Proportion of subjects with HEMI per Geboes scoring at Week 44 [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo

  6. Proportion of subjects with endoscopic remission (MES = 0) at Week 44. [ Time Frame: Week 44 ]
    To evaluate the efficacy of ABX464 versus placebo on endoscopic remission.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 use highly effective contraception methods as stated in Section 4.4. (Contraception) of this 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

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 or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant 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 within the coming 12 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05535946


Contacts
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Contact: Sharon Skare,, CPhil +33153830961 sharon.skare@abivax.com

Locations
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Sponsors and Collaborators
Abivax S.A.
Investigators
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Principal Investigator: Severine Vermeire, MD, PhD UZ Leuven, Belgium
Principal Investigator: Bruce Sands, MD, PhD Mount Sinai Health System Digestive Disease Institute, New York USA
More Information
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Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT05535946    
Other Study ID Numbers: ABX464-107
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases