NCT05535946Phase 3Active not recruiting

ABTECT - Maintenance

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-04-28Actual

Enrollment · participants1116Actual

Source updated2026-07-07Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-07 · 2 fields changed

Completion date type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Primary completion date

Recorded edit

− Previous value

2026-04

+ Updated value

2026-04-28

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Posted 2025-10-24 · 4 fields changed

Participant count type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit

− Previous value

count: 1050; type: ESTIMATED

+ Updated value

count: 1116; type: ACTUAL

Primary completion date

Recorded edit

− Previous value

2026-01

+ Updated value

2026-04

Recruitment status

Recorded edit

− Previous value

Recruiting

+ Updated value

Active not recruiting

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Study details

Conditions studied

Ulcerative Colitis

Treatments or interventions studied

ABX464DrugAlso known as Obefazimod
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Rate of subjects in clinical remission at Week 44; description: 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.; timeFrame: Week 44; measure: Number and percentage of all treatment-emergent adverse events (TEAEs); description: The Part 2 primary objective is safety; timeFrame: Week 44; measure: Number and percentage of all serious adverse events (SAEs); description: The Part 2 primary objective is safety; timeFrame: Week 44; measure: Number and percentage of all causally related TEAEs/SAEs; description: The Part 2 primary objective is safety; timeFrame: Week 44

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history