ACTIVE_NOT_RECRUITING

Study to Assess SLN124 in Patients With Polycythemia Vera

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Conditions

Polycythemia VeraPV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety, tolerability, efficacy, pharmacokinetic (PK), and Pharmacodynamic (PD) response of SLN124.

Official 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

Quick Facts

Study Start:2023-01-26
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05499013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients aged 18 years or older.
  2. * A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria:
  3. * Suitable phlebotomy history
  4. * Must agree to adhere to appropriate contraception requirements
  5. * 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.
  6. * 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.
  7. * Patients must have had a dermatological examination within 28 weeks prior to dosing.
  8. * Must have an Eastern Cooperative Oncology Group score of 0, 1, or 2.
  1. * Drug intolerance:
  2. 1. History of intolerance to oligonucleotides, or GalNAc, or any component of SLN124.
  3. 2. History of intolerance to s.c. injections.
  4. * Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks of screening.
  5. * History of major bleeding events and/or a requirement for blood transfusion therapy owing to bleeding in the last 6 months prior to screening.
  6. * Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment
  7. * 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.
  8. * Any investigational or marketed product using GalNAc targeting less than 48 weeks prior to administration of any investigational agent (excludes patients with PV who participated in Phase 1 of this study).
  9. * Clinically significant co-morbidities
  10. * Biochemical and hematological parameters:
  11. 1. Biochemical evidence of significant liver disease during screening
  12. 2. Phase 1: Hematological parameters at screening as follows: platelets \> 1,000,000/µL; or white blood cell (WBC) count \> 25,000/µL; or peripheral blasts \> 1%.

Contacts and Locations

Study Locations (Sites)

Research Site
Hammond, Louisiana, 70403
United States
Research Site
Buffalo, New York, 14203
United States
Research Site
New York, New York, 10029
United States
Research Site
Columbus, Ohio, 43210
United States
Research Site
Huntsville, Texas, 77340
United States

Collaborators and Investigators

Sponsor: Silence Therapeutics plc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-26
Study Completion Date2030-03

Study Record Updates

Study Start Date2023-01-26
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • PV

Additional Relevant MeSH Terms

  • Polycythemia Vera