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Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary endpoint revised
    • Secondary endpoints revised (4)
    v14
  2. Secondary endpoints: 3 to 4v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 26 to confirmed 20
    • Site details revised at 4 of 4 sites
    v12
  4. Study sites revised (4)v11
  5. Site contacts updated at 2 of 4 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary endpoints: 7 to 1
    • Enrollment target: 20 to 26
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 15 to 3
    v9
  2. Eligibility criteria revisedv8
  3. Enrollment target: 8 to 20
    • Eligibility criteria expanded, about 144 words
    • Site contacts updated at 1 of 4 sites
    • Study arms: 2 to 5
    v7
  4. Study sites: 2 to 4v6
  5. Enrollment target: 16 to 8
    • Eligibility criteria shortened, about 43 words
    • Secondary endpoints revised (15)
    • Study arms: 6 to 2
    v5
  6. Site contacts updated at 1 of 2 sitesv4
  7. Study sites: 1 to 2v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2023 to Dec 7, 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, open-label, Phase 1/2 study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of DNL126 in participants with Sanfilippo syndrome Type A (MPS IIIA). The core study period is 25 weeks (approximately 6 months); followed by an open-label extension (OLE), which extends through Week 97 (approximately 18 months); and a long-term extension (LTE), which extends through Week 193 (Year 4). Participants with MPS IIIA will be enrolled in two planned cohorts, and additional participants with MPS IIIA may be enrolled in three optional cohorts.
Trial Details
NCT Number NCT06181136
Lead Sponsor Denali Therapeutics Inc.
Conditions
(from sponsor)		 Mucopolysaccharidosis Type IIIA
Related terms Mucopolysaccharidosis III
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov