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A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

Study acronym: COMPASS
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from Denali Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modifiedv49 Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 63 to confirmed 65
    • Study sites: 32 to 30
    • Secondary endpoints revised (8)
  2. Primary and study completion dates: Dec 2025 to Dec 2027
    • Enrollment target: 54 to 63
    • Study sites: 33 to 32
    v48
  3. Site contacts updated at 1 of 33 sitesv47
  4. Site contacts updated at 1 of 33 sitesv46
  5. Study sites: 32 to 33v45
Show 43 earlier versionsHide 43 earlier versions
  1. Site details revised at 32 of 32 sitesv44
  2. Study sites: 30 to 32v43
  3. Study sites: 34 to 30v42
  4. Site details revised at 34 of 34 sitesv41
  5. Site contacts updated at 1 of 34 sitesv40
  6. Study sites: 33 to 34v39
  7. Primary endpoints revised (2)v38 Show 4 more changesShow less
    • Study sites: 38 to 33
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 6 to 8
    • Study title expanded, about 3 words
  8. Site contacts updated at 1 of 38 sitesv37
  9. Study sites: 37 to 38v36
  10. Site contacts updated at 6 of 37 sitesv35
  11. Study sites: 36 to 37v34
  12. Study sites: 35 to 36v33
  13. Study sites: 34 to 35v32
  14. Site contacts updated at 5 of 34 sitesv31
  15. Re-verified, no change to tracked fieldsv30
  16. Study sites: 33 to 34v29
  17. Study sites: 32 to 33v28
  18. Interventions: DNL310 (Drug), Idursulfase (Drug) to idursulfase (Drug), tividenofusp alfa (Drug)
    • Site contacts updated at 2 of 32 sites
    • Study title expanded, about 2 words
    v27
  19. Site contacts updated at 1 of 32 sitesv26
  20. Site contacts updated at 1 of 32 sitesv25
  21. Study sites: 31 to 32v24
  22. Study sites: 30 to 31v23
  23. Study sites: 29 to 30v22
  24. Study sites: 28 to 29v21
  25. Site contacts updated at 1 of 28 sitesv20
  26. Study sites: 19 to 28v19
  27. Study sites: 20 to 19v18
  28. Study sites revised (20)v17
  29. Study sites: 17 to 20v16
  30. Study sites: 12 to 17v15
  31. Study sites: 10 to 12v14
  32. Study sites: 9 to 10v13
  33. Study sites: 8 to 9v12
  34. Study sites: 7 to 8v11
  35. Study sites: 3 to 7v10
  36. Site contacts updated at 1 of 3 sitesv9
  37. Re-verified, no change to tracked fieldsv8
  38. Site contacts updated at 1 of 3 sitesv7
  39. Study sites: 2 to 3v6
  40. Start date changed from estimate of Jul 2022 to Jul 21, 2022
    • Study title expanded, about 1 word
    v5
  41. Study sites: 1 to 2
    • Start date: Jun 2022 to Jul 2022
    v4
  42. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: May 2022 to Jun 2022
    v3
  43. Eligibility criteria expanded, about 2 wordsv2
  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 Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.
Trial Details
NCT Number NCT05371613
Lead Sponsor Denali Therapeutics Inc.
Conditions
(from sponsor)		 Mucopolysaccharidosis II
Related terms Mucopolysaccharidosis II, Sudden Infant Death
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov