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Clinical Trials in the UK / NCT05295433
Recruiting Phase 1/2

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

NCT05295433 · tracked via the Priya Life Science UK tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 1/2
Started
2022-03-08
Last updated
2025-12-23

Condition(s) studied

Methylmalonic Acidemia

Investigational drug(s) / intervention(s)

mRNA-3705

mRNA-3705: A sterile liquid for injection

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
Healthy volunteers
No
Inclusion Criteria: * Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during Study mRNA-3705-P101 Part 1. * Completed the End of treatment (EOT) Visit (or End of Study Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study. Exclusion Criteria: * 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, at the discretion of the Investigator, may put the individual at increased risk by participating in this study. * History of liver and/or kidney transplant. NOTE: Other inclusion and exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
UCLA Medical Center Los Angeles California Recruiting
Lucile Packard Children's Hospital at Stanford Palo Alto California Recruiting
Altman Clinical and Translational Research Institution San Diego California Recruiting
Stollery Children's Hospital University of Alberta Edmonton Alberta Recruiting
Hospital For Sick Children Toronto Ontario Recruiting
Hôpital Necker - Enfants Malades APHP Paris France Recruiting
Erasmus MC Rotterdam Netherlands Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Recruiting
Hospital Universitario Cruces Barakaldo Vizcaya Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Birmingham Children's Hospital NHS Foundation Trust Birmingham United Kingdom Terminated
Royal Manchester Childrens Hospital Manchester United Kingdom Recruiting

More ModernaTX, Inc. trials in the UK

Other trials for the same condition

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 NCT05295433 on ClinicalTrials.gov ↗ ← All trials in the UK