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Follow-up Study of AAV-Mediated Gene Transfer (UX111; Previously Known as ABO-102) for MPS Type IIIA

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. 6 versions Re-verified since Apr 9, 2025, no change to tracked fieldsv16-v21
  2. Primary endpoints: 1 to 2 Enrollment target: 33 to 41 · Study sites: 3 to 4 · Primary and study completion dates: Jun 2027 to Aug 2027 · 6 morev15 Show 9 more changesShow less
    • Enrollment target: 33 to 41
    • Study sites: 3 to 4
    • Primary and study completion dates: Jun 2027 to Aug 2027
    • Interventions: Adjuvant Immunosuppression (IS) Therapy (Drug), No Investigational Product (Other) to Adjuvant Immunomodulatory (IM) Therapy (Drug), No Investigational Product (Other)
    • Secondary endpoints: 4 to 6
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 2 words
    • Collaborators shortened, about 3 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. 5 versions Re-verified since Aug 2, 2023, no change to tracked fieldsv10-v14
  4. Phase: Not specified to Phase 3 Enrollment target: 50 to 33 · Primary and study completion dates: Dec 31, 2026 to Jun 2027 · Interventions: ABO-102 (Biological) to Adjuvant Immunosuppression (IS) Therapy (Drug), No Investigational Product (Other) · 4 morev9 Show 7 more changesShow less
    • Enrollment target: 50 to 33
    • Primary and study completion dates: Dec 31, 2026 to Jun 2027
    • Interventions: ABO-102 (Biological) to Adjuvant Immunosuppression (IS) Therapy (Drug), No Investigational Product (Other)
    • Eligibility criteria revised
    • Secondary endpoints: 19 to 4
    • Study description shortened, about 23 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Lead sponsor: Abeona Therapeutics, Inc to Ultragenyx Pharmaceutical Inc Trial status: Recruiting to Enrolling by Invitation · Study description expanded, about 17 words · Site details revised at 3 of 3 sites · 1 morev7 Show 4 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Study description expanded, about 17 words
    • Site details revised at 3 of 3 sites
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v6
  3. Site details revised at 1 of 3 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting Secondary endpoints: 15 to 19 · Site details revised at 3 of 3 sitesv4 Show 2 more changesShow less
    • Secondary endpoints: 15 to 19
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: May 1, 2020 to Sep 28, 2020 Secondary endpoints: 13 to 15v3 Show 1 more changeShow less
    • Secondary endpoints: 13 to 15

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 0 to 3v2
  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.
The main objective of this study is to evaluate the safety/tolerability and efficacy of UX111 (previously known as ABO-102) in participants with Mucopolysaccharidosis IIIA (MPS IIIA).
Trial Details
NCT Number NCT04360265
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Mucopolysaccharidosis IIIA, MPS IIIA, Sanfilippo Syndrome, Sanfilippo A
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov