The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Boston Clinical Trials Inc - Internal Medicine
Boston, Massachusetts, United States
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 176 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 197 (28 days after each study injection)
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Up to Day 347 (up to 6 months after last study injection)
Number of Participants with Adverse Events of Special Interest (AESI), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention and/or Study Participation
Time frame: Up to Day 887 (end of study)
Cumulative Number of New Gadolinium (Gd)-enhancing Longitudinal Relaxation Time (T1) Hyperintense Lesions, as Measured by Magnetic Resonance Imaging (MRI) from Baseline to Month 12 and End of Study (Day 887)
Time frame: Baseline to Month 12 and Day 887 (end of study)
Mean Number of Gd-enhancing T1 Hyperintense Lesions Per Scan, as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)
Time frame: Baseline to Month 12 and Day 887 (end of study)
Cumulative Number of New and/or Newly Enlarging Transverse Relaxation Time (T2)-weighted Hyperintense Lesions as Measured by MRI from Baseline to Month 12 and End of Study (Day 887)
Time frame: Baseline to Month 12 and Day 887 (end of study)
Time to First New Disease Activity on Study as Defined by a Clinical Attack Indicative of Central Nervous System (CNS) Involvement at a Site Remote to the First Attack or a New and/or Newly Enlarging T2 or Gd-enhancing Lesion on MRI
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Quest Research Institute
Farmington Hills, Michigan, United States
RECRUITINGSharlin Health & Neurology
Ozark, Missouri, United States
TERMINATEDWashington University School of Medicine Neurology Clinical Unit
St Louis, Missouri, United States
RECRUITINGOklahoma Medical Research Foundation (OMRF) MS Center of Excellence
Oklahoma City, Oklahoma, United States
RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGANESC Research
El Paso, Texas, United States
RECRUITINGSaturn Research Solutions
Plano, Texas, United States
RECRUITINGUniversity of the Sunshine Coast Clinical Trials
Birtinya, Queensland, Australia
RECRUITINGNorth Bristol NHS Trust - Southmead Hospital
Bristol, United Kingdom
RECRUITING...and 7 more locations
Time frame: Up to Day 887 (end of study)
Geometric Mean Titer (GMT) of B-cell Neutralizing Antibodies (nAbs) and/or Vaccine Antigen-specific Binding Antibodies (bAbs) at Days 1, 85, and 197
Time frame: Days 1, 85, and 197
Geometric Mean Fold Rise (GMFR) of B-cell nAbs and/or Vaccine Antigen-specific bAbs at Days 1, 85, and 197
Time frame: Days 1, 85, and 197
Change in Expanded Disability Status Scale (EDSS) Score at 3- and 6-month Intervals from Baseline to End of Study (Day 887)
Time frame: Baseline, Day 887 (end of study)
Time to 6-month Confirmed Disability Progression
Time frame: Up to Day 887 (end of study)