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Indication Polycythemia Vera

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Summary

Phase 1/2 study with an open-label dose escalation phase followed by a randomized, double-blind phase of SLN124 in patients with Polycythemia Vera

Study Treatment

Phase 1:

  • SLN124 subcutaneous injection

Phase 2:

  • SLN124 subcutaneous injection
  • Placebo

Key Study Criteria*

Inclusion:

  • Patients ≥ 18 years old
  • Confirmed Polycythemia Vera diagnosis (2016 WHO criteria)
  • Patients must have had 3 or more phlebotomies in the last 6 months
  • Patients treated with cytoreductives can participate if being treated with a stable dose

Exclusion:

  • Drug intolerance:
    • - History of intolerance to oligonucleotides, or GalNAc
    • - History of intolerance to subcutaneous injections
  • Clinically significant thrombosis within 12 weeks of screening
  • Clinically significant co-morbidities

*Additional criteria apply

Primary Outcome Measures for Phase 1

Primary:

  • Incidence of treatment-emergent adverse events
  • Assessment of number of phlebotomies at different intervals

Secondary:

  • Pharmacokinetics: area under the plasma concentration (AUC) and peak plasma concentration (Cmax)
  • Pharmacodynamic biomarkers: change in hematocrit, change in iron, and blood cell parameters

Primary Outcome Measures for Phase 2

  • Number of patients who are phlebotomy free after treatment with placebo or SLN124

Study Duration

  • Screening (3 weeks) plus 34 weeks in Phase 1 study
  • All patients in Phase 1 can enter Phase 2
  • Patients entering the Study in Phase 2 will have a screening period of 3 weeks plus 48 weeks on study

Get More Information

ClinicalTrials.gov: NCT05499013
SLN124 Phase 1/2 Study in Polycythemia Vera Fact Sheet
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