Table of Contents
- Trial overview
- Multiple sclerosis studies
- Post-COVID syndrome study
- Trial design and phases
- Outcomes measured in the trials
- Who the trials are for
Trial overview
The source data includes five interventional studies of Vidofludimus Calcium, which is listed in the trials as IMU-838.[1] These studies are being done in people with different forms of multiple sclerosis and in people with post-COVID syndrome.[1][2][3][4][5]
Across the trials, researchers are mainly checking efficacy (whether the treatment helps), safety, and tolerability (how well people can take the treatment).[1][2][3][4][5]
Multiple sclerosis studies
Three trials focus on multiple sclerosis, which is a long-term disease of the brain and spinal cord.[1][2][4][5]
NCT03846219 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter trial in people with relapsing-remitting multiple sclerosis (RRMS).[1] It has 270 planned participants and includes MRI-based measures of disease activity up to Week 24.[1]
This study has two parts: a main cohort looking at the effect of 45 mg/day IMU-838 on MRI disease activity, and a sub-study that collects more efficacy and safety data and supports dose-response modeling, which means it helps researchers understand how different doses may relate to the effect seen.[1]
NCT05054140 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study in people with progressive multiple sclerosis.[2] It plans to enroll 467 participants and measures the annualized rate of percent brain volume change during the main treatment period.[2]
The brain volume outcome is measured with MRI and the SIENA method, which is a computer-based way to track whole-brain atrophy, meaning loss of brain tissue over time.[2]
NCT05201638 and NCT05134441 are Phase 3 studies in adults with relapsing multiple sclerosis (RMS).[4][5] Each study plans to enroll 1,050 participants and compares IMU-838 with placebo.[4][5]
These Phase 3 trials are designed to show whether the treatment can delay relapses, using time to first confirmed relapse as the main endpoint.[4][5] A confirmed relapse is a relapse that is checked and judged by the Independent Neurology Evaluation Committee, or INEC.[4][5]
Post-COVID syndrome study
2024-511628-16-00 is a Phase 2 randomized, adaptive study called RAPID / REVIVE in people with post-COVID syndrome (PCS).[3] It is listed as completed and includes 376 participants.[3]
The main goal was to compare IMU-838 with control treatment and see whether it improved overall physical function by Day 56, using the SF-36 Physical Function score.[3] The SF-36 Physical Function score is a patient-reported measure, meaning patients answer questions about how well they can do daily physical activities.[3]
Trial design and phases
All five studies are interventional, which means the researchers give a treatment and then watch what happens.[1][2][3][4][5]
Four studies are randomized, and three are double-blind and placebo-controlled, so treatment assignment is done by chance and people in the study do not know who gets active treatment or placebo.[1][2][3][4][5]
The source data shows both Phase 2 and Phase 3 research, which means the program includes early testing and larger confirmatory studies.[1][2][3][4][5]
Outcomes measured in the trials
The main outcomes are different across studies, but they all try to show whether the treatment changes disease activity or patient function.[1][2][3][4][5]
- MRI lesions: In RRMS, researchers count combined unique active lesions and gadolinium-enhancing lesions, which are signs of active inflammation on brain scans.[1]
- Brain volume change: In progressive multiple sclerosis, researchers measure how much the brain volume changes over time, which can show brain tissue loss.[2]
- Time to first confirmed relapse: In relapsing multiple sclerosis studies, researchers measure how long it takes before a first relapse is confirmed by the study committee.[4][5]
- Physical function: In the post-COVID syndrome study, researchers use the SF-36 Physical Function score to see whether daily physical ability improves.[3]
Who the trials are for
The studies are aimed at people with the condition named in each trial, such as RRMS, progressive multiple sclerosis, RMS, or post-COVID syndrome.[1][2][3][4][5]
The source data does not give the full entry rules, so it does not show every detail about who can or cannot join.[1][2][3][4][5]
What is clear is that the trials are built around specific patient groups, and each study uses outcomes that fit the condition being tested.[1][2][3][4][5]
