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NCT05295433 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Methylmalonic Acidemia, sponsored by ModernaTX.

Recruiting
Registry status
Phase 1
Development phase
56
Enrollment target
12
Study locations

NCT05295433: Recruiting Phase 1 study of Methylmalonic Acidemia, sponsored by ModernaTX.

NCT05295433 is a Phase 1 study of Methylmalonic Acidemia that is actively recruiting participants, run by ModernaTX. The registered enrollment target is 56 participants, below the 418-participant average among 6 other Methylmalonic Acidemia trials with a reported enrollment target (87% lower). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05295433, a Phase 1 study of Methylmalonic Acidemia, is actively recruiting participants, sponsored by ModernaTX.

RECRUITING
Registry status
Phase 1
Development phase
56 participants
Enrollment target
12
Study locations

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.

Conditions Studied

Interventions

  • DRUG mRNA-3705

Study Locations (12)

Other

  • Hôpital Necker - Enfants Malades APHP - Paris
  • Erasmus MC - Rotterdam
  • Universitair Medisch Centrum Utrecht - Utrecht
  • Hospital Universitario 12 de Octubre - Madrid
  • Birmingham Children's Hospital NHS Foundation Trust - Birmingham
  • Royal Manchester Childrens Hospital - Manchester

California

  • UCLA Medical Center - Los Angeles
  • Lucile Packard Children's Hospital at Stanford - Palo Alto
  • Altman Clinical and Translational Research Institution - San Diego

Alberta

  • Stollery Children's Hospital University of Alberta - Edmonton

Ontario

  • Hospital For Sick Children - Toronto

Vizcaya

  • Hospital Universitario Cruces - Barakaldo

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-03-08
Est. Completion 2034-04-02
Phase Phase 1
ModernaTX

90 total trials

What NCT05295433 shows while recruiting

NCT05295433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 418-participant average among 6 other Methylmalonic Acidemia trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Methylmalonic Acidemia appearing as the primary indexed condition, and to 1 intervention - of which mRNA-3705 is the first listed.

NCT05295433 lists 12 locations in 5 states (Other, California, Alberta).

Frequently Asked Questions

What is clinical trial NCT05295433 about?

NCT05295433 is a clinical study titled "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". 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 mRN...

What is the current status of trial NCT05295433?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-03-08. Estimated completion is 2034-04-02.

What conditions does trial NCT05295433 study?

This clinical trial studies the following conditions: Methylmalonic Acidemia.

What interventions are being tested in trial NCT05295433?

The interventions under investigation include: mRNA-3705 (DRUG).

Who is sponsoring clinical trial NCT05295433?

This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05295433 being conducted?

This trial has 12 study locations across California, Alberta, Ontario, Vizcaya. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05295433, the US trial registry maintained by the National Library of Medicine. NCT05295433 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.