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Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Jan 31, 2026 to Aug 31, 2027v28
  2. Site details revised at 1 of 35 sitesv27
  3. Primary endpoints revised (3)v26 Show 5 more changesShow less
    • Enrollment target: 68 to 77
    • Study sites: 17 to 35
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 16 to 33
    • Study description shortened, about 3 words
  4. Primary completion date: Mar 5, 2025 to Jan 31, 2026
    • Study completion date: Jan 6, 2027 to Jan 31, 2026
    v25
  5. Study sites: 15 to 17v24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites revised (15)v23
  2. Primary endpoints: 2 to 3v22 Show 5 more changesShow less
    • Enrollment target: 58 to 68
    • Eligibility criteria expanded, about 218 words
    • Secondary endpoints: 29 to 16
    • Study description expanded, about 24 words
    • Site contacts updated at 1 of 15 sites
  3. Study sites: 16 to 15v21
  4. Study sites: 15 to 16v20
  5. Primary endpoints: 1 to 2v19 Show 5 more changesShow less
    • Enrollment target: 42 to 58
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 6 to 29
    • Study description expanded, about 15 words
    • Study arms: 7 to 1
  6. Study sites: 13 to 15v18
  7. Site details revised at 1 of 13 sitesv17
  8. Enrollment target: 36 to 42
    • Secondary endpoints: 8 to 6
    • Study description revised
    • Study arms: 6 to 7
    v16
  9. Eligibility criteria expanded, about 63 words
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site contacts updated at 2 of 13 sites
    • Study description expanded, about 4 words
    v15
  10. Study sites: 12 to 13
    • Secondary endpoints: 6 to 8
    v14
  11. Re-verified, no change to tracked fieldsv13
  12. Study sites: 11 to 12v12
  13. Site contacts updated at 8 of 11 sitesv11
  14. Study sites: 9 to 11v10
  15. Study sites: 7 to 9v9
  16. Re-verified, no change to tracked fieldsv8
  17. Study sites: 6 to 7v7
  18. Study sites: 3 to 6v6
  19. Study sites: 2 to 3v5
  20. Study sites: 1 to 2
    • Start date changed from estimate of Apr 9, 2021 to Apr 15, 2021
    v4
  21. Trial status: Not Yet Recruiting to Recruitingv3 Show 10 more changesShow less
    • Primary completion date: Jun 2023 to Mar 5, 2025
    • Start date: Mar 2020 to Apr 9, 2021
    • Primary endpoints: 3 to 1
    • Enrollment target: 46 to 36
    • Study completion date: Jun 2025 to Jan 6, 2027
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 149 words
    • Study arms: 4 to 6
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 1 word
  22. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Moderna
49 trials monitored
See 3 trials at risk
This 3-part, Phase 1/2 study is designed to characterize the safety, tolerability, and pharmacological activity (as assessed by biomarker measurements) and to determine the selected dose of mRNA-3927 in participants with genetically confirmed propionic acidemia (PA). After establishing a dose with an acceptable safety and pharmacodynamic (PD) response for participants ≥1 year of age in Part 1, participants will be enrolled in Part 2 (which will serve as the pivotal study) to allow for determination of the efficacy, safety, and PD of mRNA-3927. Part 3 will evaluate the safety, efficacy and PD response of mRNA-3927 in infants (\<1 year of age).
Trial Details
NCT Number NCT04159103
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 Propionic Acidemia
Related terms Acid-Base Imbalance, Acidosis, Amino Acid Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases, Metabolism, Inborn Errors, Propionic Acidemia
Enrollment 77 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov