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IMU-838 for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple SclerosisIMU-838 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, IMU-838, to see if it's effective and safe for people with progressive multiple sclerosis.

Eligible Conditions
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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MRI Brain and Cervical Spine
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Metformin 500 Mg Oral Tablet, up to 4 tablets a day
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DUOC-01

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 24 weeks

24 weeks
Efficacy IMU-838 versus placebo
Efficacy of IMU-838 versus placebo
Safety IMU-838 versus placebo

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
MRI Brain and Cervical Spine
1
Metformin 500 Mg Oral Tablet, up to 4 tablets a day
1
DUOC-01

Trial Design

2 Treatment Groups

IMU-838
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: IMU-838 · Has Placebo Group · Phase 2

IMU-838
Drug
Experimental Group · 1 Intervention: IMU-838 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo matching IMU-838 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vidofludimus
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Immunic AGLead Sponsor
7 Previous Clinical Trials
2,876 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
2,310 Patients Enrolled for Multiple Sclerosis
Robert J. Fox, MDPrincipal InvestigatorMellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
2 Previous Clinical Trials
2,100 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
2,100 Patients Enrolled for Multiple Sclerosis
R. F., MDPrincipal InvestigatorUniversity Cleveland Ohio
2 Previous Clinical Trials
2,100 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
2,100 Patients Enrolled for Multiple Sclerosis

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for the study if you are aged 18 to 65 years (inclusive).
You have EDSS score between 3.0 and 6.5 (both inclusive).
You have given written informed consent before the beginning of any study-related procedure.
You have a disability that is not related to a relapse in the last 24 months before randomization.
Patients with SLE are randomly assigned to one of two treatment groups: either an oral prednisone (PO) or a placebo (P) regimen.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Los Angeles County Harbor UCLA, Medical Center and Lundquist Institute50.0%
Montreal Neurological Inst.50.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What state do they live in?
California100.0%
References

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