450 Participants Needed

IMU-838 for Progressive Multiple Sclerosis

(CALLIPER Trial)

Recruiting at 94 trial locations
AM
Overseen ByAndreas Muehler, MD
Prior Safety DataThis treatment has passed at least one previous human 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?

IMU-838 (Vidofludimus calcium) has been studied for safety in healthy male subjects and patients with conditions like rheumatoid arthritis and Crohn's disease. Some studies reported hematuria (blood in urine) at higher doses, which seemed to be related to the amount taken.12345

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?

Research on teriflunomide, a similar drug, shows it can help manage multiple sclerosis by reducing relapses and improving quality of life. This suggests that IMU-838, which is related, might also be effective for progressive multiple sclerosis.211121314

Who Is on the Research Team?

RJ

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

I haven't had a relapse in 2 years and my diagnosis follows specific criteria.
Your EDSS score at screening is between 3.0 and 6.5.
My condition has not worsened in the last 2 years.
See 5 more

Exclusion Criteria

My symptoms are not caused by conditions other than MS.
I haven't used any experimental drugs recently.
I tested positive for COVID-19 within the last 14 days or have recently recovered with negative tests.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Main Treatment

Participants receive either IMU-838 or placebo daily to evaluate efficacy, safety, and tolerability

120 weeks

Open Label Extension

Participants may opt into continuation of treatment with IMU-838 long-term

Up to 8 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMU-838
Trial Overview The CALLIPER trial is testing IMU-838's effectiveness and safety against a placebo in managing Progressive Multiple Sclerosis. Participants will be randomly assigned to either receive IMU-838 or a matching placebo in this double-blind study where neither they nor the researchers know who gets which treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IMU-838Experimental Treatment1 Intervention
IMU-838 as tablet; Administration: Oral - daily
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo as tablet; Administration: Oral - daily

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunic AG

Lead Sponsor

Trials
8
Recruited
3,300+

Published Research Related to This Trial

In a 6-month phase II trial involving patients with secondary progressive multiple sclerosis, the novel immunosuppressive drug β-D-Mannuronic acid (M2000) showed a significant reduction in disability progression compared to conventional treatments, with a notable decrease in the Expanded Disability Status Scale (EDSS) score (p < 0.009).
M2000 demonstrated better performance in MRI-related measurements compared to conventional drugs, and importantly, no short-term side effects were observed, indicating its potential safety and efficacy as a treatment option for MS.
A controlled, randomized phase II clinical trial for efficacy and safety evaluation of mannuronic acid in secondary progressive form of multiple sclerosis.Najafi, S., Moghadam, NB., Saadat, P., et al.[2022]
Teriflunomide, an oral treatment for relapsing-remitting multiple sclerosis, has shown consistent efficacy in clinical trials, with safety data pooled from over 3044 patients and a treatment duration exceeding 12 years.
The safety profile of teriflunomide is manageable, with common side effects including ALT increase, headache, diarrhea, hair thinning, and nausea, mostly mild-to-moderate in intensity, and no new safety concerns identified in long-term use.
Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions.Comi, G., Freedman, MS., Kappos, L., et al.[2022]
Vidofludimus (IMU-838) demonstrated good safety and tolerability in healthy male subjects across a wide dose range (10-50 mg) during two phase 1 studies, indicating it may be a safe option for treating conditions like rheumatoid arthritis and Crohn's disease.
The pharmacokinetics of IMU-838 were dose-proportional, with steady-state concentrations reached within 6-8 days, supporting its use as a once-daily oral medication without food affecting its absorption.
Safety, Tolerability and Pharmacokinetics of Vidofludimus calcium (IMU-838) After Single and Multiple Ascending Oral Doses in Healthy Male Subjects.Muehler, A., Kohlhof, H., Groeppel, M., et al.[2021]

Citations

Teriflunomide for the treatment of relapsing multiple sclerosis: a review of clinical data. [2021]
Multiple sclerosis relapses are associated with increased fatigue and reduced health-related quality of life - A post hoc analysis of the TEMSO and TOWER studies. [2021]
A controlled, randomized phase II clinical trial for efficacy and safety evaluation of mannuronic acid in secondary progressive form of multiple sclerosis. [2022]
Teriflunomide Safety and Efficacy in Advanced Progressive Multiple Sclerosis. [2022]
Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. [2022]
Safety, Tolerability and Pharmacokinetics of Vidofludimus calcium (IMU-838) After Single and Multiple Ascending Oral Doses in Healthy Male Subjects. [2021]
A double-blind, randomized, placebo-controlled phase 2 trial evaluating the selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium in relapsing-remitting multiple sclerosis. [2022]
[EDMUS--a new European databank for multiple sclerosis. A brief introduction of ongoing and planned multicenter studies within the scope of the "European Concentrated Action for Multiple Sclerosis"]. [2013]
Immunomodulatory agents for the treatment of relapsing multiple sclerosis: a systematic review. [2019]
Gateways to clinical trials. [2007]
Radiomics Analysis for 177Lu-DOTAGA-(l-y)fk(Sub-KuE) Targeted Radioligand Therapy Dosimetry in Metastatic Prostate Cancer-A Model Based on Clinical Example. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer. [2023]
Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security