A Phase 3 interventional study of Sapablursen and Placebo in Polycythemia Vera, sponsored by Ono Pharmaceutical Co., Ltd.. Recruiting at 38 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
Poland, United Kingdom, Brazil, Hungary, Austria, France
The purpose of this study is to evaluate the efficacy and safety of sapablursen when added on to current standard of care (SOC) for Polycythemia Vera (PV) therapy. The study will be conducted in three sequential parts (Part 1a blinded treatment, Part 1b open-label treatment, \& Part 2 long-term extension). Participants may receive treatment for up to 156 weeks.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 250 is above the median of 52 across 204 interventional studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sapablursen (32 Weeks) - Sapablursen (124 Weeks Open-label)
Drug: Sapablursen
Placebo (32 Weeks) - Sapablursen (124 Weeks Open-label)
Drug: Sapablursen · Drug: Placebo
Administered subcutaneously (SC)
Also known as: ONO-0530, ISIS 702843
Administered SC
Percentage of Participants with Absence of Phlebotomy Eligibility
Response is defined as absence of phlebotomy eligibility.
Time frame: Week 20 through Week 32
Number of Phlebotomies
Time frame: Week 0 through Week 32
Percentage of Participants with Hct Control
Defined as all local laboratory Hct \<45% without phlebotomy.
Time frame: Week 0 to Week 32
Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score
Time frame: Baseline, Week 32
Change from Baseline in Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS)
Time frame: Baseline, Week 32
Percentage of Participants with Absence of Phlebotomy Eligibility
Response is defined as absence of phlebotomy eligibility.
Time frame: Week 20 through Week 52
Number of Phlebotomies
Time frame: Week 0 through Week 52
Percentage of Participants with Hct Control
Defined as all local laboratory Hct \<45% without phlebotomy.
Time frame: Week 0 through Week 52
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2028, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
Poland, United Kingdom, Brazil, Hungary, Austria, France
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sapablursen
Ono Pharmaceutical Co., Ltd. →