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

Recruiting now · Phase 1/Phase 2

Conditions studied: Methylmalonic Acidemia

In brief

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.

Key facts

Study ID

NCT05295433

Run by

ModernaTX, Inc.

People needed

56

Starts

2022-03-08

Expected to finish

2034-04-02

Last updated by the study team

2025-12-23

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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