NCT05130437

A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).

Detailed description

The study will assess long-term safety of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT)/early termination (ET) visit of the mRNA-3927-P101 study will have the option to enroll into this extension study provided all eligibility criteria have been met. The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (90 days after the EOT visit). All participants will enter the study receiving mRNA-3927 at the same dose and at the same dosing interval last received in the mRNA-3927-P101 study.

Conditions

• Propionic Acidemia

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-3927	mRNA-3927 dispersion for IV infusion

Timeline

• Start date: 2021-11-09
• Primary completion: 2029-12-04
• Completion: 2031-12-04
• First posted: 2021-11-23
• Last updated: 2026-03-23

Locations

22 sites across 8 countries: United States, Canada, France, Japan, Netherlands, Saudi Arabia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study