Actively Recruiting
A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705
Led by ModernaTX, Inc. · Updated on 2025-12-23
56
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the long-term safety and clinical effects of mRNA-3705 in people with isolated methylmalonic acidemia (MMA) caused by methylmalonyl-coenzyme A mutase (MUT) deficiency who have already taken part in previous mRNA-3705 studies. The study includes participants who meet all eligibility requirements and focuses on monitoring safety and clinical activity over several years. Participants will continue receiving mRNA-3705 at the same dose and schedule as in their previous study, either every two weeks or every three weeks, unless changes are recommended by the sponsor. The study has two parts: a Treatment Period that continues until certain conditions occur, such as drug approval or participant decision to stop, and a Follow-up Period lasting up to six months after the last dose. During participation, individuals will undergo regular assessments including monitoring for treatment-related side effects and measuring key biomarkers like plasma methylmalonic acid levels. Researchers will track health events, hospital visits, antibody levels, and quality of life using specialized questionnaires. Safety monitoring will continue throughout the study and follow-up, with total involvement potentially spanning more than six years.
CONDITIONS
Brief Title
An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed assigned dose regimen treatment period in prior mRNA-3705 clinical studies or eligible due to missed doses from COVID-19 vaccination
- Completed End of Treatment Visit in prior mRNA-3705 study within 10 days before first dose in this extension study
You will not qualify if you...
- Not expected to benefit from continued mRNA-3705 treatment as judged by the Investigator
- Any clinical or laboratory abnormality or medical condition increasing risk from study participation as judged by the Investigator
- History of liver and/or kidney transplant
- Other inclusion and exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 years or until treatment discontinuation
Participants receive mRNA-3705 at the same dose levels and dosing intervals as in their previous study, continuing treatment unless criteria for discontinuation are met.
Dosing every 2 or 3 weeks, visit frequency as per dosing schedule
Duration - Up to 6 months
Participants are monitored for safety and clinical outcomes for up to 6 months after the last dose of study drug.
Trial Site Locations
Total: 12 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
3
Altman Clinical and Translational Research Institution
San Diego, California, United States, 92037
Actively Recruiting
4
Stollery Children's Hospital University of Alberta
Edmonton, Alberta, Canada, T6G 2R7
Actively Recruiting
5
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
6
Hôpital Necker - Enfants Malades APHP
Paris, France, 75015
Actively Recruiting
7
Erasmus MC
Rotterdam, Netherlands, 3015 AA
Actively Recruiting
8
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
9
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Actively Recruiting
10
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
11
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH
Terminated
12
Royal Manchester Childrens Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
M
Moderna WeCare Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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