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Immunomodulator

IMU-838 for Progressive Multiple Sclerosis (CALLIPER Trial)

Phase 2
Waitlist Available
Led By Robert J. Fox, MD
Research Sponsored by Immunic AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed according to 2017 revised McDonald Criteria 1 and the 2013 revised classification of disease courses 2 as either
No evidence of relapse in the last 24 months before randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 weeks
Awards & highlights

CALLIPER Trial Summary

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

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for IMU-838 aren't listed here, common drug-related side effects could include gastrointestinal issues like nausea and diarrhea; liver function changes; potential risk of infections due to immune system impact; fatigue; headache; and allergic reactions.

CALLIPER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had a relapse in 2 years and my diagnosis follows specific criteria.
Select...
My condition has not worsened in the last 2 years.
Select...
I have been diagnosed with SPMS or PPMS according to the latest criteria.
Select...
I am between 18 and 65 years old.
Select...
I am between 18 and 65 years old.

CALLIPER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Efficacy of IMU-838 versus placebo
Efficacy of IMU-838 versus placebo in terms of disability worsening
Other outcome measures
Safety IMU-838 versus placebo

CALLIPER Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMU-838
2020
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

Immunic AGLead Sponsor
7 Previous Clinical Trials
2,852 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

Media Library

IMU-838 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05054140 — Phase 2
Multiple Sclerosis Research Study Groups: Placebo, IMU-838
Multiple Sclerosis Clinical Trial 2023: IMU-838 Highlights & Side Effects. Trial Name: NCT05054140 — Phase 2
IMU-838 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054140 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any way to join this research program?

"This clinical trial seeks to involve 450 individuals aged 18-65 who are suffering from multiple sclerosis. Additional criteria for participation includes: adult status, EDSS score of 3.0-6.5, willingness and ability to adhere to the research protocol, documented evidence of disability progression unconnected with relapse in the last two years before enrollment, no proof of relapse within two years prior to randomization and a diagnosis according to 2017 revised McDonald Criteria 1 & 2013 revised classification of disease courses 2."

Answered by AI

Has this trial been previously attempted in a similar capacity?

"Currently, there are 4 ongoing trials for IMU-838 distributed across 27 cities and 25 nations. Immunic AG initiated the first clinical trial of this drug in 2018; it enrolled 263 patients and achieved Phase 2 approval status before concluding. Two subsequent studies have emerged since its inception."

Answered by AI

Are there any previous experiments conducted with IMU-838?

"IMU-838 was initially tested in 2018 by Eastern Research, Inc. with two clinical trials already concluded; the present landscape comprises of 4 active studies and a considerable number are conducted from Northbrook, Illinois."

Answered by AI

Are recruitment efforts still ongoing for this experiment?

"The clinical trial is actively recruiting, with the initial post date of September 30th 2021 and the most recent update occurring on October 21st 2022."

Answered by AI

How many participants are currently collaborating in this experiment?

"Yes, clinicaltrials.gov displays that this clinical trial is actively seeking recruits. It was published on September 30th 2021 and last modified October 21st 2022, with the aim of enrolling 450 patients across 13 sites."

Answered by AI

Are there many healthcare facilities in North America conducting this research endeavor?

"This clinical trial is being coordinated by Consultants in Neurology, Ltd. in Northbrook, Illinois and sites at Los Angeles County Harbor UCLA Medical Center & Lundquist Institute (Torrance, California), Montreal Neurological Inst. in Montréal (New mexico) as well as 13 additional locations throughout the nation."

Answered by AI

Has the regulatory authority sanctioned IMU-838?

"The safety of IMU-838 was rated a 2 because this Phase 2 trial has only produced clinical data confirming its security, while no information exists quantifying the effectiveness of the drug."

Answered by AI

Does the trial have any age restrictions for potential participants?

"This research study is enlisting participants aged 18 or above, and below 65 years of age."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Los Angeles County Harbor UCLA, Medical Center and Lundquist Institute
Montreal Neurological Inst.
Shepherd Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
Georgia
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
2021. "Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05054140.
All > Primary Progressive Multiple Sclerosis > Multiple Sclerosis
~129 spots leftby Apr 2025
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