NLY01 for Multiple Sclerosis
(TAG-MS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).
Researchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).
Who Is on the Research Team?
Ellen M Mowry, MD, MCR
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug or placebo. Initial dose of 5 mg subcutaneous weekly for the first 4 weeks, then 10 mg subcutaneous weekly, with pre-planned dose adjustments if adverse events occur.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NLY01
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
5 mg subcutaneous weekly for the first 4 weeks, then 10 mg subcutaneous weekly, with pre-planned dose adjustments if adverse events prevent full dosage.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Multiple Sclerosis Society
Collaborator
Race to Erase MS
Collaborator
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