Clinical Trials in the UK / NCT06735248
Recruiting
Phase 2
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
NCT06735248 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Multiple Sclerosis
Investigational drug(s) / intervention(s)
mRNA-1195Placebo
mRNA-1195: IM injection
Placebo: IM injection
Study summary
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Up to Day 176 (7 days after each study injection)
- Number of Participants with Unsolicited Adverse Events (AEs) — Up to Day 197 (28 days after each study injection)
- Number of Participants with Medically Attended Adverse Events (MAAEs) — 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 — Up to Day 887 (end of study)
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Boston Clinical Trials Inc - Internal Medicine | Boston | Massachusetts | Terminated |
| Quest Research Institute | Farmington Hills | Michigan | Recruiting |
| Sharlin Health & Neurology | Ozark | Missouri | Terminated |
| Washington University School of Medicine Neurology Clinical Unit | St Louis | Missouri | Recruiting |
| Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence | Oklahoma City | Oklahoma | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| ANESC Research | El Paso | Texas | Recruiting |
| Saturn Research Solutions | Plano | Texas | Recruiting |
| University of the Sunshine Coast Clinical Trials | Birtinya | Queensland | Recruiting |
| North Bristol NHS Trust - Southmead Hospital | Bristol | United Kingdom | Recruiting |
| Cardiff and Vale University Health Board - University Hospital Wales | Cardiff | United Kingdom | Recruiting |
| Anne Rowling Regenerative Neurology Clinic, University of Edinburgh | Edinburgh | United Kingdom | Recruiting |
| NHS Greater Glasgow & Clyde - Institute of Neurological Sciences | Glasgow | United Kingdom | Recruiting |
| Cambridge Clinical Research Centre | London | United Kingdom | Recruiting |
| East Kent Hospitals University NHS Foundation Trust | London | United Kingdom | Recruiting |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | United Kingdom | Recruiting |
| Sheffield Teaching Hospital NHS foundation Trust, Herries Road | Sheffield | United Kingdom | Recruiting |
More ModernaTX, Inc. trials in the UK
Other trials for the same condition
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Active, not recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06735248 on ClinicalTrials.gov ↗ ← All trials in the UK