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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Fedratinib (Primary)
  • Indications Essential thrombocythaemia; Myelofibrosis; Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms JAKARTA
  • Sponsors Sanofi

Most Recent Events

  • 15 Jun 2023 Results comparing safety outcomes using matching-adjusted indirect comparison from SIMPLIFY-1 vs JAKARTA and pooled SIMPLIFY-2 , MOMENTUM vs JAKARTA2, presented at the 28th Congress of the European Haematology Association
  • 06 Jun 2023 Results of an analysis assessing (Indirect treatment comparison) ITC of safety outcomes between MMB and FED in patients with MF using data from following clinical trials: NCT04173494; NCT01969838; NCT02101268; NCT01523171; NCT01437787 presented at the 59th Annual Meeting of the American Society of Clinical Oncology
  • 01 Jul 2022 Results from pooled data from JAKARTA and JAKARTA-2 studies evaluating the efficacy and safety of Fedratinib at 400mg/day dose, published in the British Journal of Haematology.

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