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A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 17 to 18v22
  2. Primary completion date: Mar 2026 to Dec 2027
    • Study completion date: Mar 2027 to Dec 2028
    v21
  3. Study sites: 16 to 17v20
  4. Study sites: 15 to 16v19
  5. Study sites: 14 to 15v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 13 to 14v17
  2. Study sites: 12 to 13v16
  3. Study sites: 11 to 12v15
  4. Study sites: 10 to 11v14
  5. Study sites: 9 to 10v13
  6. Study sites: 8 to 9v12
  7. Study sites: 7 to 8v11
  8. Lead sponsor: Ascendis Pharma Growth Disorders A/S to Ascendis Pharma A/S
    • Study sites: 6 to 7
    v10
  9. Study sites: 5 to 6v9
  10. Study sites: 4 to 5v8
  11. Study sites: 3 to 4v7
  12. Study sites: 2 to 3v6
  13. Study sites: 1 to 2v5
  14. Re-verified, no change to tracked fieldsv4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2024 to Jan 23, 2024
    v3
  16. Start date: Dec 2023 to Feb 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to \< 2 years at the time of randomization.
Trial Details
NCT Number NCT06079398
Lead Sponsor Ascendis Pharma A/S
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov