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ABTECT - Maintenance

ABTECT - Maintenance

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2030-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Among both induction studies, subjects assessed as responders will be randomized as follows into Part 1 of the maintenance study according to their induction treatment:

* ABX464 Dose 50 mg QD
* ABX464 Dose 25 mg QD
* Placebo. All subjects with clinical response who were dosed with placebo in the induction studies will be randomized into the placebo group.

Among both induction studies, subjects assessed as non-responders will be randomized as follows into Part 2 of the maintenance study according to their induction treatment:

* ABX464 Dose 50 mg QD (all subjects who received 50 mg in induction)
* ABX464 Dose 25 mg QD (all subjects who received 25 mg in induction)
* Subjects who were allocated to placebo in the induction study will be randomized to obefazimod 50 mg or 25 mg in a blinded manner.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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ABX464 50mg - Responder subjects at the end of induction

Subjects will be orally dosed during 44 weeks

Group Type PLACEBO_COMPARATOR