Actively Recruiting
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
Led by ModernaTX, Inc. · Updated on 2025-12-23
56
Participants Needed
12
Research Sites
629 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.
CONDITIONS
Official 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 the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition because of missing more than 3 consecutive doses due to COVID-19 vaccination during Study mRNA-3705-P101 Part 1
- Completed the End of Treatment (EOT) Visit or End of Study Visit in Study mRNA-3705-P101 within 10 days before the first dose of mRNA-3705 in this extension study
You will not qualify if you...
- Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator
- Any clinical or laboratory abnormality or medical condition that may increase risk by participating, at the Investigator's discretion
- History of liver and/or kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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