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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517949-13-00 | Other Identifier | EU CT Number |
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The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1195 Dose Level 1 (Low Dose) | Experimental | Participants will receive 3 intramuscular (IM) injections at dose level 1 (low dose) on a 0-, 2-, and 6-month schedule. |
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| mRNA-1195 Dose Level 2 (High Dose) | Experimental | Participants will receive 3 IM injections at dose level 2 (high dose) on a 0-, 2-, and 6-month schedule. |
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| Placebo | Placebo Comparator | Participants will receive 3 placebo IM injections on a 0-, 2-, and 6-month schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1195 | Biological | IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | Contact | 1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Clinical Trials Inc - Internal Medicine | Terminated | Boston | Massachusetts | 02131 | United States | |
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| Placebo | Biological | IM injection |
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| 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) | 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 | 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 | 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 | 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) | Baseline, Day 887 (end of study) |
| Time to 6-month Confirmed Disability Progression | Up to Day 887 (end of study) |
| Quest Research Institute |
| Recruiting |
| Farmington Hills |
| Michigan |
| 48334 |
| United States |
| Sharlin Health & Neurology | Terminated | Ozark | Missouri | 65721 | United States |
| Washington University School of Medicine Neurology Clinical Unit | Recruiting | St Louis | Missouri | 63110 | United States |
| Oklahoma Medical Research Foundation (OMRF) MS Center of Excellence | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390-8806 | United States |
| ANESC Research | Recruiting | El Paso | Texas | 79912 | United States |
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| Saturn Research Solutions | Recruiting | Plano | Texas | 75024 | United States |
| University of the Sunshine Coast Clinical Trials | Recruiting | Birtinya | Queensland | 04575 | Australia |
| North Bristol NHS Trust - Southmead Hospital | Recruiting | Bristol | BS10 5NB | United Kingdom |
| Cardiff and Vale University Health Board - University Hospital Wales | Recruiting | Cardiff | CF14 4XW | United Kingdom |
| Anne Rowling Regenerative Neurology Clinic, University of Edinburgh | Recruiting | Edinburgh | EH16 4SB | United Kingdom |
| NHS Greater Glasgow & Clyde - Institute of Neurological Sciences | Recruiting | Glasgow | G51 4TF | United Kingdom |
| Cambridge Clinical Research Centre | Recruiting | London | CB2 0SL | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust | Recruiting | London | CT1 3NG | United Kingdom |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle upon Tyne | NE14LP | United Kingdom |
| Sheffield Teaching Hospital NHS foundation Trust, Herries Road | Recruiting | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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