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

Официальное название

A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of mRNA-1195 Intramuscular Injection in Participants 18 to ≤55 Years of Age With Multiple Sclerosis

Обзор

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

Вмешательства

• Биопрепарат mRNA-1195
  IM injection
• Биопрепарат Placebo
  IM injection

Первичные конечные точки

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Срок оценки: Up to Day 176 (7 days after each study injection)]
• Number of Participants with Unsolicited Adverse Events (AEs) [Срок оценки: Up to Day 197 (28 days after each study injection)]
• Number of Participants with Medically Attended Adverse Events (MAAEs) [Срок оценки: 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 [Срок оценки: Up to Day 887 (end of study)]

Вторичные конечные точки (8)

• 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, Day 887 (end of study)]
• Time to 6-month Confirmed Disability Progression [Срок оценки: Up to Day 887 (end of study)]

Критерии участия

Критерии включения

• Medically stable as determined by Investigator's medical evaluation, which will include assessment of medical history, physical examination, laboratory testing, and review of any previously conducted cardiac monitoring.
• Participants who are Epstein-Barr virus (EBV)-seropositive at screening.
• Participants diagnosed with relapsing multiple sclerosis, including those with a single clinical attack (that is, clinically isolated syndrome \[CIS\]), as well as participants diagnosed with radiologically isolated syndrome, within 24 months of Screening Visit (that is, early in their multiple sclerosis course) and in the opinion of the Investigator have been neurologically stable for at least 30 days prior to Visit 1/Day 1.
• A participant who could become pregnant is eligible to participate if they are not pregnant or breast/chest feeding and using a highly effective contraceptive method.

Критерии исключения

• Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4 Fahrenheit °F\]) within 72 hours prior to or at screening or Day 1.
• History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
• Received or plans to receive any non-study vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 \[COVID-19\] regardless of vaccine type) within 28 days before or after any study injection, or within 14 days before or after any study injection for the influenza vaccine.
• Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Received systemic immunosuppressants within the 30 day period prior to screening (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent)
• Participants with any documented history of myocarditis, pericarditis, or myopericarditis.
• Has donated ≥450 milliliter (mL) of blood products within 28 days prior to screening or plans to donate blood products within 28 days post-study injection.

Note: Other inclusion and exclusion criteria may apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• Boston Clinical Trials Inc - Internal Medicine — Boston
• Quest Research Institute — Farmington Hills
• Sharlin Health & Neurology — Ozark
• Washington University School of Medicine Neurology Clinical Unit — St Louis
• Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence — Oklahoma City
• University of Texas Southwestern Medical Center — Dallas
• ANESC Research — El Paso
• Saturn Research Solutions — Plano

Великобритания · 8 центров

• North Bristol NHS Trust - Southmead Hospital — Bristol
• Cardiff and Vale University Health Board - University Hospital Wales — Cardiff
• Anne Rowling Regenerative Neurology Clinic, University of Edinburgh — Edinburgh
• NHS Greater Glasgow & Clyde - Institute of Neurological Sciences — Glasgow
• Cambridge Clinical Research Centre — London
• East Kent Hospitals University NHS Foundation Trust — London
• The Newcastle Upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne
• Sheffield Teaching Hospital NHS foundation Trust, Herries Road — Sheffield

Австралия · 1 центр

• University of the Sunshine Coast Clinical Trials — Birtinya

Идентификаторы

NCT: NCT06735248 · mRNA-1195-P201 · 2024-517949-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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