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

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NCT05134441 · readout ≤ 103 d

Sponsored by Immunic AG (industry) · IMUX — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,121actual
Sites
91
Countries
Albania, Algeria, Bulgaria +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-11-18actualWhen the study began enrolling
Primary completionNov 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionSep 2033estimatedThe whole study's end, after follow-up
First posted2021-11-26actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-02-23actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Multiple Sclerosis

Interventions

  • Drug: IMU-838 tablets — also filed as vidofludimus calcium
  • Drug: Placebo matching IMU-838 tablets — also filed as Placebo matching vidofludimus calcium

Primary outcome

what the primary-completion date above is the date OF
To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
measured 72 weeks

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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