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Purpose

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

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
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
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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 names:
    • 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 names:
    • Obefazimod

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Alan Moss, MD

More Details

Status
Recruiting
Sponsor
Abivax S.A.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.