IMU-838 for Progressive Multiple Sclerosis
(CALLIPER Trial)

Recruiting in Palo Alto (17 mi)

+94 other locations

Overseen byRobert J. Fox, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Immunic AG

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

+7 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.

+4 more

Participant Groups

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.

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