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Antisense Oligonucleotide

Sapablursen for Polycythemia Vera

Phase 2
Recruiting
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 17 to week 37
Awards & highlights

Study Summary

This trial is testing whether a new drug can reduce the amount of blood taken from people with polycythemia vera and improve their quality of life.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of sapablursen are not listed here, similar medications may cause reactions at injection sites, liver problems, fatigue, potential immune system impacts leading to increased infection risk, and possible changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with polycythemia vera according to WHO 2016 criteria.
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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.
Select...
I stopped my cytoreductive therapy 3 months ago or have been on a stable dose for the same duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 17 to week 37
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 17 to week 37 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the frequency of phlebotomy comparing Baseline with the last 20 weeks of the 37 week Treatment Period
Secondary outcome measures
Change in the Myeloproliferative Neoplasm Symptom Assessment Form-Total Symptom Score (MPN-SAF-TSS) From Baseline to Week 37
Proportion of patients achieving a reduction in the frequency of phlebotomy by ≥ 30%, ≥ 50%, ≥ 75% and ≥ 90% comparing Baseline with the last 20 weeks of the 37-week Treatment Period

Trial Design

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.

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
145 Previous Clinical Trials
15,204 Total Patients Enrolled

Media Library

Sapablursen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05143957 — Phase 2
Polycythemia Vera Clinical Trial 2023: Sapablursen Highlights & Side Effects. Trial Name: NCT05143957 — Phase 2
Sapablursen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143957 — Phase 2
Polycythemia Vera Research Study Groups: Sapablursen Dose Level 1, Sapablursen Dose Level 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are actively managing this clinical trial?

"This clinical trial is presently accepting patients from 12 distinct sites. These locations include, but are not limited to Houston, San Antonio and Los Angeles; thus participants should consider enrolling in the nearest centre for minimal travel requirements."

Answered by AI

Who is able to meet the criteria for participating in this research trial?

"To qualify for this trial, candidates must have polycythemia and range between 18 and 80 years of age. A total of 40 people are necessary to complete the research requirements."

Answered by AI

Is the demographic of this research limited to individuals below forty years old?

"This clinical trial is open to people aged 18 to 80. Additionally, there are 2 studies available for minors and 53 trials designated specifically toward seniors over 65 years old."

Answered by AI

Has the IONIS-TMPRSS6-LRx gained sanction from the Food and Drug Administration?

"Although there is no evidence yet to support its efficacy, the safety of IONIS-TMPRSS6-LRx was rated a 2 due to some data suggesting it has been well tolerated in Phase 2 trials."

Answered by AI

What is the current enrollment for this clinical research?

"The sponsor, Ionis Pharmaceuticals, Inc., is looking to enroll 40 eligible participants in this trial from multiple sites such as Norris Comprehensive Cancer Center and University of Texas MD Anderson Cancer Center. These locations include Houston, Texas and San Antonio, New york respectively."

Answered by AI

Are enrollments still open for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is still looking for participants - having been initially uploaded on December 30th 2021 and most recently edited on September 23rd 2022. 40 patients are needed across a dozen distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~15 spots leftby Jan 2025