IMU-838 for Progressive Multiple Sclerosis
(CALLIPER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new medication called IMU-838 to help adults with Progressive Multiple Sclerosis. The medication aims to reduce inflammation and slow down the worsening of the disease. The study will check if the medication is safe and effective over a long period.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that previous or current use of MS treatments may be a factor. It's best to discuss your specific medications with the trial coordinators.
What is known about the safety of IMU-838 (Vidofludimus calcium) in humans?
What makes the drug IMU-838 unique for treating progressive multiple sclerosis?
IMU-838 (Vidofludimus calcium) is unique because it works by selectively inhibiting an enzyme called DHODH, which is involved in the metabolism of cells, particularly affecting immune cells that contribute to inflammation in multiple sclerosis. This mechanism is different from many other treatments that primarily focus on modulating the immune system more broadly.678910
What data supports the effectiveness of the drug IMU-838 for Progressive Multiple Sclerosis?
Who Is on the Research Team?
Robert J. Fox, MD
Principal Investigator
Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
Are You a Good Fit for This Trial?
Adults aged 18-65 with Progressive Multiple Sclerosis (SPMS or PPMS) who haven't had a relapse in the last 24 months. They must have an EDSS score of 3.0 to 6.5, show disability progression not related to relapses, and be able to follow the study protocol. Excluded are those with other possible causes for symptoms, previous MS treatments within certain timeframes, recent SARS-CoV-2 infection without negative tests, positive tests for TB or hepatitis B/C/HIV, use of investigational products recently, or signs of NMO/MOG-associated encephalomyelitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Main Treatment
Participants receive either IMU-838 or placebo daily to evaluate efficacy, safety, and tolerability
Open Label Extension
Participants may opt into continuation of treatment with IMU-838 long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IMU-838
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunic AG
Lead Sponsor