A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Polycythemia Vera

Number of phlebotomies from Week 0 through Week 32 Hct control, defined as all local laboratory Hct <45% from Week 0 through Week 32 without phlebotomy. A single Hct value ≥45% is allowed. Hct values from each clinical site’s local laboratory will be used for this endpoint

Key secondary: Response, defined as absence of phlebotomy eligibility, starting from Week 20 through Week 32. Phlebotomy eligibility is defined as either of the following: - Hct ≥45% and at least 3% (absolute) higher than the baseline Hct confirmed through 2 consecutive assessments OR Hct ≥48%. Hct values from each clinical site’s local laboratory will be used for the primary endpoint to allow same day phlebotomy decisions., Key secondary: Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 8a (PROMIS Fatigue SF-8a) total T-score (8 items) at Week 32; • Change from baseline in the Myelofibrosis Symptom Assessment Form version 4.0 Total Symptom Score (MFSAF v4.0 TSS) (7 items) at Week 32, Other Secondary: For participants originally randomized to sapablursen: • Response, defined as absence of phlebotomy eligibility, from Week 20 through Week 52; • Number of phlebotomies from Week 0 through Week 52; • Hct control from Week 0 through Week 52, Safety: • Frequency of treatment-emergent adverse events (TEAEs); • Frequency of serious adverse events • Frequency of TEAEs leading to dose reduction, interruption, or discontinuation of study treatment

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