An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in the mRNA-3705-P101 Study

  • STATUS
    Recruiting
  • End date
    Apr 2, 2034
  • participants needed
    33
  • sponsor
    ModernaTX, Inc.
Updated on 26 April 2022

Summary

The primary objective of this study is to evaluate the long-term safety of mRNA-3705 administered to participants with methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in Study mRNA-3705-P101 (NCT04899310).

Description

Participants with MMA due to MUT deficiency who were previously enrolled, completed the Treatment Period, and completed the end of treatment (EOT) Visit of the mRNA-3705-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 (up to 2 years after the last dose of study drug).

Treatment Period will continue unless one of the following occurs: mRNA-3705 receives marketing approval and reimbursement in the country of origin of the participant, the participant discontinues study drug, the participant is no longer receiving clinical benefit (in the opinion of the Investigator), or Sponsor discontinues the development of mRNA-3705.

Details
Condition Methylmalonic Acidemia
Treatment mRNA-3705
Clinical Study IdentifierNCT05295433
SponsorModernaTX, Inc.
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Completed the mRNA-3705-P101 assigned dose regimen treatment time period
Completed the EOT Visit in Study mRNA-3705-P101 within 10 days of first dose of mRNA-3705 in the current 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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