120 Participants NeededMy employer runs this trial

NLY01 for Multiple Sclerosis

(TAG-MS Trial)

SM
Overseen ByStudy Manager
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?

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?

EM

Ellen M Mowry, MD, MCR

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 60 years old.
I have MS and have been stable on treatment for at least 12 months.
Body mass index ≥27.0 kg/m2

Exclusion Criteria

I do not have serious kidney disease, type 1 diabetes, diabetic eye disease, or substance abuse.
No concerns about candidacy of individual on part of person's neurologist or study team clinicians
Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

96 weeks
Baseline, week 48, and week 96

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NLY01

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: NLY01 (Study Drug)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Multiple Sclerosis Society

Collaborator

Trials
100
Recruited
10,600+

Race to Erase MS

Collaborator