A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
ModernaTX, Inc.
Study ID
NCT06735248
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • mRNA-1195 — BIOLOGICAL
    IM injection
  • Placebo — BIOLOGICAL
    IM injection

Study Details

The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.

Key Dates

Start date
Apr 16, 2025
Status verified
Dec 2025
Primary completion
Jan 8, 2029
Completion
Jan 8, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: mRNA-1195 Dose Level 1 (Low Dose)
    Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule.
  • Experimental: mRNA-1195 Dose Level 2 (High Dose)
    Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule.
  • Placebo Comparator: Placebo
    Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule.

Primary Outcome Measure

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 176 (7 days after each study injection) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Boston Clinical Trials Inc - Internal MedicineBostonMassachusetts02131-
Quest Research InstituteFarmington HillsMichigan48334-
Sharlin Health & NeurologyOzarkMissouri65721-
Washington University School of Medicine Neurology Clinical UnitSt LouisMissouri63110-
Oklahoma Medical Research Foundation (OMRF) MS Center of ExcellenceOklahoma CityOklahoma73104-
University of Texas Southwestern Medical CenterDallasTexas75390-8806-
ANESC ResearchEl PasoTexas79912
Frank Chairz
[email protected]
915-974-2200
Aamr Herekar, MD (PRINCIPAL_INVESTIGATOR)
Saturn Research SolutionsPlanoTexas75024-

Find similar trials in Boston, MA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Boston Clinical Trials Inc - Internal Medicine· Boston, MAQuest Research Institute· Farmington Hills, MISharlin Health & Neurology· Ozark, MOWashington University School of Medicine Neurology Clinical Unit· St Louis, MOOklahoma Medical Research Foundation (OMRF) MS Center of Excellence· Oklahoma City, OKUniversity of Texas Southwestern Medical Center· Dallas, TX

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