Trial Profile

A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 05 Mar 2026

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At a glance

23 Feb 2026 Planned End Date changed from 1 Sep 2032 to 1 Sep 2033.
23 Feb 2026 Planned primary completion date changed from 1 Sep 2024 to 1 Nov 2026.
13 Feb 2026 According to an Immunic media release, the company announced the pricing of a private placement with gross proceeds of up to USD 400 million, priced at-the-market under Nasdaq rules. The proceeds from this financing are expected to support the completion of the Phase 3 ENSURE trials in relapsing multiple sclerosis, the initiation of a Phase 3 trial in primary progressive multiple sclerosis, and the transition into a commercial organization.

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