Sapablursen for Polycythemia Vera

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ionis Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests sapablursen, an injectable medication, on patients with polycythemia vera to see if it can reduce the need for regular blood removal and improve their quality of life.

Eligibility Criteria

This trial is for individuals with polycythemia vera who depend on regular blood removal (phlebotomy) to manage their condition. They must meet specific diagnostic criteria and either have not been on cytoreductive therapy or be on a stable dose for at least 3 months. People can't join if they have severe spleen issues, certain other diseases like HIV or hepatitis, recent major surgery, cancer within the last 5 years (with some exceptions), or bleeding/coagulation disorders.

Inclusion Criteria

I haven't had or don't currently need treatment to reduce my blood cell counts. If I was treated, it ended 3 months ago.

I stopped my cytoreductive therapy 3 months ago or have been on a stable dose for the same duration.

Participant must be phlebotomy dependent

+2 more

Exclusion Criteria

I have been diagnosed with PPV-MF according to IWG-MRT standards.

I haven't had any serious bleeding or blood clotting issues in the last month.

I haven't had cancer in the last 5 years, except for certain skin cancers, cervical carcinoma in situ, or treated non-metastatic prostate cancer.

+5 more

Participant Groups

The study tests sapablursen's effectiveness in reducing the need for phlebotomies and improving life quality in patients with polycythemia vera. It aims to see if this treatment can help manage red blood cell levels better than current methods.

2Treatment groups

Experimental Treatment

Group I: Sapablursen Dose Level 2Experimental Treatment1 Intervention

Sapablursen will be administered by SC injection every 4 weeks

Group II: Sapablursen Dose Level 1Experimental Treatment1 Intervention

Sapablursen will be administered by SC injection every 4 weeks.