NCT05134441Phase 3Active not recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

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 completion2026-11Estimated

Enrollment · participants1121Actual

Source updated2026-02-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-02-23 · 4 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~1050 participants (planned)~~

+ After

1121 participants (actual)

Primary completion date changed

− Before

~~Sep 2024~~

+ After

Nov 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Multiple Sclerosis

Treatments or interventions studied

IMU-838 tabletsDrugAlso known as vidofludimus calcium
Placebo matching IMU-838 tabletsDrugAlso known as Placebo matching vidofludimus calcium

Primary outcomes · main study measures

measure: To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse; description: Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.; timeFrame: 72 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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