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RecruitingLast updated: 19 September 2024

Imprssion: This study is evaluating how effective a drug called sapablursen is at reducing the frequency of phlebotomy (blood withdrawals) in people with phlebotomy dependent polycythemia vera (PD-PV)A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients With Phlebotomy Dependent Polycythemia Vera (PD-PV)

Clinical summary

Summary

This study consists of 4 periods:

  1. Screening period: up to 7 weeks;
  2. Treatment Period: 37 weeks
  3. Treatment Extension Period: 36 weeks; and
  4. Post-treatment Period: 13 weeks.

In the Treatment Period, the study drug (sapablursen) is given by subcutaneous (under the skin) injection(s). There will be a total of 10 doses given over about 8 months.

In the Treatment Extension Period, there will be a total of 9 doses given over about 8 months.

Participants will be assigned to receive one of 2 Dosing Levels - a higher or a lower level, with an equal chance of being assigned to either Dosing Level. All participants will receive the study drug, there is no placebo.

Conditions

This trial is treating patients with Phlebotomy Dependent Polycythemia Vera

Cancer

Blood Cancers Haematological

Age

People18 - 90

Phase

II

Trial Acronym

Imprssion

More information

Trial Identifiers

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Trial sponsor

Ionis Pharmaceuticals, Inc.

Scientific Title

A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients With Phlebotomy Dependent Polycythemia Vera (PD-PV)

Eligibility

Inclusion

  1. Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
  2. Participant must be phlebotomy dependent.
  3. Participants do not need to be on cytoreductive therapy and do not need to have been previously treated with cytoreductive therapy. If the patient was previously on cytoreductive therapy it must have been discontinued at least 3 months prior to Screening, with all associated AEs resolved. If the patient is currently on cytoreductive therapy they must be on a stable dose of hydroxyurea, recombinant or PEGylated interferon, or ruxolitinib for at least 3 months prior to Screening.

Exclusion

  1. Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
  2. Moderate to severe splenic pain or spleen-related organ obstruction
  3. Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
  4. Known primary or secondary immunodeficiency
  5. Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
  6. Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
  7. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been successfully treated
  8. Surgery requiring general anesthesia within 1 month prior to Screening

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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