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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

Introduction

SANRECO is a clinical study testing an experimental treatment: Divesiran (also referred as SLN124). The aim of the study is to learn the effects of this treatment in people living with Polycythemia Vera (PV). We are currently recruiting for the Phase 2 part of the study.

Study Status

Phase 1:

  • Recruitment completed.

Phase 2:

  • Open for recruitment.

Study Treatment

Phase 1:

  • Divesiran subcutaneous injection

Phase 2:

  • Divesiran subcutaneous injection
  • Placebo

Objectives

The main objectives of Phase 1 are to find out:

  • How safe divesiran is and whether it has any unwanted effects.
  • The effect of divesiran on the proportion of red blood cells and any improvement in PV related symptoms.

The main objectives of Phase 2 are to find out:

  • The percentage of participants who have their red blood cells remaining at or below a certain level (45%) in the absence of having excess blood removed (i.e. phlebotomies) between 18 weeks and 36 weeks after treatment.
  • The effect of divesiran in improving PV related symptoms.

Phase 1 and Phase 2 Key Study Criteria*

Inclusion:

Phase 1

  • Patients ≥ 18 years old.
  • Confirmed Polycythemia Vera diagnosis (2016 WHO criteria).
  • Patients must have had 3 or more phlebotomies in the last 6 months, or 5 or more in the last 12 months.
  • Patients treated with cytoreductives can participate if being treated with a stable dose.

Phase 2

  • Patients must have Hct < 43% prior to dosing.
  • Patients who complete Phase 1 can participate in Phase 2, if eligible.
  • New patients (not participated in Phase 1) must be ≥ 18 years old.
  • New patients must have confirmed Polycythemia Vera diagnosis (2016 WHO criteria).
  • New patients must have had 3 or more phlebotomies in the last 28 weeks, or 5 or more in the last 12 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


Study Duration

Phase 1:

  • Screening period of 3 weeks plus 34 weeks on study

Phase 2:

  • Screening period of 3 weeks plus 180 weeks on study

 

Timeline

Phase 1:

  • Study Start: 26 Jan 2023, Enrolment Completed

Phase 2:

  • Study Start: Expected Oct 2024

 

Locations:

             Please click here to view study locations

FAQs?

What does participation in the SANRECO clinical trial involve?

  • Phase 1 of the study; patients were assigned to different dose groups of Divesiran and dosed on 4 occasions at 6-week intervals with a 16-week follow-up after the last dose.
  • Phase 2 of the study includes double-blind and open label parts.
    • The double-blind part has 3 different arms: 2 Divesiran dosing regimens arms and 1 placebo arm.
    • A double-blind extension part where all patients will receive divesiran.
    • An open label extension part where all patients will receive divesiran.

Get More Information

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