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A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Jun 2026 → Dec 20, 2027
See other at-risk trials from AO GENERIUM

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Dec 20, 2027 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Interventions: GNR-055 1.0-2.0-3.0 mg/kg (Drug), GNR-055 2.0 mg/kg (Drug), GNR-055 3.0 mg/kg (Drug) to GNR-055 1.0-2.0-3.0 mg/kg (Drug), GNR-055 2.0 mg/kg (Drug), GNR-055 3.0 mg/kg (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Site details revised at 5 of 5 sites
  2. Primary completion date: Feb 2025 to Jun 2026v4
  3. Re-verified, no change to tracked fieldsv3
  4. Study completion date: Mar 2025 to Mar 2028v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AO GENERIUM
9 trials monitored
See 1 trial at risk
This is phase 2/3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.
Trial Details
NCT Number NCT05208281
Lead Sponsor AO GENERIUM
Conditions
(from sponsor)		 Mucopolysaccharidosis Type II, Metabolic Diseases
Related terms Cognition Disorders, Cognitive Dysfunction, Connective Tissue Diseases, Genetic Diseases, Inborn, Genetic Diseases, X-Linked, Heredodegenerative Disorders, Nervous System, Intellectual Disability, Lysosomal Storage Diseases, Mental Disorders, Metabolic Diseases, Mucopolysaccharidosis II, Nervous System Diseases, Neurobehavioral Manifestations, Neurocognitive Disorders, Neurologic Manifestations, Sudden Infant Death, X-Linked Intellectual Disability
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov