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RecruitingLast updated: 14 May 2024

SLN: This study is testing the safety and effectiveness of different doses of a new treatment (called SLN124) in adults with Polycythemia VeraPhase 1/2 Study With an Open-label Dose Escalation Phase Followed by a Randomized, Double-blind Phase of SLN124 in Patients With Polycythemia Vera

Clinical summary

Summary

This study has two phases. Phase 1 is a dose-finding study. Participants enrolled in this part of the study will receive escalating doses of SLN124 which will be administered as an injection under the skin. Participants enrolled in Part 2 will be randomly allocated to receive either SLN124 or a placebo, both given via an injection under the skin.

Please note, PCCTU will apply the teletrial model once in the Phase 2 portion of this study.

Conditions

This trial is treating patients with polycythaemia vera

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

SLN

More information

Trial Identifiers

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Trial sponsor

Silence Therapeutics plc

Scientific Title

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

Eligibility

Inclusion

  • Male and female patients aged 18 years or older.
  • A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria:
  • Suitable phlebotomy history
  • Must agree to adhere to appropriate contraception requirements
  • Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before dosing and have recovered from any adverse events due to cytoreductive therapy.
  • Patients receiving cytoreductive therapy with hydroxyurea, interferon, busulfan or ruxolitinib must have received a stable dose of cytoreductive therapy for at least 12 weeks before dosing and with no planned change in dose.
  • Patients must have had a dermatological examination within 6 months prior to screening.
  • Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.

Exclusion

  • Drug intolerance:

    1. History of intolerance to oligonucleotides, or GalNAc, or any component of SLN124.
    2. History of intolerance to s.c. injections.
  • Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks of screening.
  • History of major bleeding events and/or a requirement for blood transfusion therapy owing to bleeding in the last 6 months prior to screening.
  • Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment
  • Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent.
  • Any investigational or marketed product using GalNAc targeting less than 48 weeks prior to administration of any investigational agent.
  • Clinically significant co-morbidities
  • Biochemical and hematological parameters:

    1. Biochemical evidence of significant liver disease during screening
    2. Hematological parameters at screening as follows: platelets 1,000,000/µL; or white blood cell (WBC) count > 25,000/µL; or peripheral blasts < 1%.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

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