NCT03341962Phase 2Terminated

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

Study sponsor: Immunic AG

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 completion2022-11-16Actual

Enrollment · participants263Actual

Source updated2024-03-05Last 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

IMU-838DrugAlso known as IM90838, vidofludimus calcium
PlaceboDrugAlso known as Placebo (for IMU-838)

Primary outcomes · main study measures

Read the study measures

measure: Induction Phase: Symptomatic Remission and Endoscopic Healing at Week 10; description: Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint; timeFrame: 10 weeks

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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