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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The primary objective of this study is to evaluate the long-term safety 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
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:
• 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 the mRNA-3705-P101 study.
• Completed the End of treatment (EOT) Visit in Study mRNA-3705-P101 within 10 days of first dose of mRNA-3705 in the current study.
Locations
United States
California
UCLA Medical Center
RECRUITING
Los Angeles
Lucile Packard Children's Hospital at Stanford
RECRUITING
Palo Alto
Altman Clinical and Translational Research Institution
RECRUITING
San Diego
Other Locations
Canada
Stollery Children's Hospital University of Alberta
RECRUITING
Edmonton
Hospital For Sick Children
RECRUITING
Toronto
France
Hôpital Necker - Enfants Malades APHP
RECRUITING
Paris
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Spain
Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
TERMINATED
Birmingham
Royal Manchester Childrens Hospital
RECRUITING
Manchester
Contact Information
Primary
Moderna WeCare Team
WeCareClinicalTrials@modernatx.com
1-866-663-3762
Time Frame
Start Date: 2022-03-08
Estimated Completion Date: 2034-04-02
Participants
Target number of participants: 63
Treatments
Experimental: mRNA-3705
Participants will receive mRNA-3705 at the same dose levels at the same dosing interval (every 2 weeks \[Q2W\], or every 3 weeks \[Q3W\]) last received in the clinical study of mRNA-3705 in which they initially participated, unless the Sponsor recommends modification.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.