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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

ModernaTX, Inc. · NCT05295433

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
56
US sites recruiting
3
Study start
March 8, 2022
Record last updated
December 23, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: mRNA-3705

Conditions: Methylmalonic Acidemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • UCLA Medical Center

    Los Angeles, CA 90095

    Site contact: Monserrath Campos · monserrathcampos@mednet.ucla.edu

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, CA 94304

    Site contact: Thu Quan · tquan@stanford.edu

  • Altman Clinical and Translational Research Institution

    San Diego, CA 92037

    Site contact: Nicolle Mendez · n3mendez@health.ucsd.edu

Study contacts (from the official record)

  • Moderna WeCare Team · 1-866-663-3762 · WeCareClinicalTrials@modernatx.com
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An Extension Study to Evaluate the Long-Term Safety and Clinical… (NCT05295433) | Bored Studies