NCT03760003Phase 2Completed

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

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 completion2021-04-01Actual

Enrollment · participants355Actual

Source updated2025-11-28Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Ulcerative Colitis

Treatments or interventions studied

ABX464 100 mgDrugAlso known as Obefazimod 100 mg
ABX464 50 mgDrugAlso known as Obefazimod 50 mg
ABX464 25 mgDrugAlso known as Obefazimod 25 mg
PlaceboDrugAlso known as Obefazimod placebo control

Primary outcomes · main study measures

Read the study measures

measure: Reduction From Baseline in Modified Mayo Score (MMS) at Week 8; description: Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.; timeFrame: Week 8

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.

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