In short
Clinical trials are studying Vidofludimus Calcium in people with relapsing multiple sclerosis, progressive multiple sclerosis, and post-COVID syndrome. These trials look at whether it can help with disease activity, relapse timing, physical function, and brain volume changes, while also checking safety and tolerability.
Key points
- Clinical trials of Vidofludimus Calcium are studying several patient groups, including people with relapsing-remitting multiple sclerosis, relapsing multiple sclerosis, progressive multiple sclerosis, and post-COVID syndrome. The source data includes Phase 2 and Phase 3 trials, so the research is both early and later stage. Key outcomes include MRI lesion activity, brain volume change, time to first confirmed relapse, and physical function. Some studies are authorized, and one post-COVID syndrome study is completed. These trials are designed to see whether Vidofludimus Calcium can improve disease-related outcomes and how safe and tolerable it is in the studied populations.
Trial overview
The source data includes five interventional studies of Vidofludimus Calcium, which is listed in the trials as IMU-838. These studies are being done in people with different forms of multiple sclerosis and in people with post-COVID syndrome.2345
Across the trials, researchers are mainly checking efficacy (whether the treatment helps), safety, and tolerability (how well people can take the treatment).2345
Multiple sclerosis studies
Three trials focus on multiple sclerosis, which is a long-term disease of the brain and spinal cord.245
NCT03846219 is a Phase 2, randomized, double-blind, placebo-controlled, multicenter trial in people with relapsing-remitting multiple sclerosis (RRMS). It has 270 planned participants and includes MRI-based measures of disease activity up to Week 24.
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.
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).45 Each study plans to enroll 1,050 participants and compares IMU-838 with placebo.45
These Phase 3 trials are designed to show whether the treatment can delay relapses, using time to first confirmed relapse as the main endpoint.45 A confirmed relapse is a relapse that is checked and judged by the Independent Neurology Evaluation Committee, or INEC.45
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.2345
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.2345
The source data shows both Phase 2 and Phase 3 research, which means the program includes early testing and larger confirmatory studies.2345
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.2345
- MRI lesions: In RRMS, researchers count combined unique active lesions and gadolinium-enhancing lesions, which are signs of active inflammation on brain scans.
- 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.45
- 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.2345
The source data does not give the full entry rules, so it does not show every detail about who can or cannot join.2345
What is clear is that the trials are built around specific patient groups, and each study uses outcomes that fit the condition being tested.2345