Constellation Pharmaceuticals is conducting a randomized, double-blind, Phase 3 trial in adult patients with myelofibrosis who have not been previously treated with a JAK inhibitor. The purpose of the study is to evaluate the efficacy and safety of pelabresib, an oral BET inhibitor, plus ruxolitinib (a JAK inhibitor) compared with ruxolitinib alone.
Trial status: Recruiting, Phase 3
Primary endpoint: SVR35 at 24 weeks
Key secondary endpoint: TSS50 by MFSAF v4.0 at 24 weeks
Other secondary endpoints
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BET=bromodomain and extra-terminal domain; DIPSS=Dynamic International Prognostic Scoring System; OS=overall survival; PFS=progression-free survival; SVR35=spleen volume reduction of ≥35%; TSS=Total Symptom Score; TSS50=Total Symptom Score improvement of ≥50%; MFSAF=Myelofibrosis Symptom Assessment Form.