SRA-MMB-301 (R/R)

A Randomized, Double-Blind, Phase 3 Study of Momelotinib vs Danazol in Symptomatic, Anemic Subjects With Previously JAKi Treated Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis

Study treatments

• arm 1: momelotinib plus placebo to match danazol
• arm 2: danazol plus placebo to match momelotinib

Inclusion criteria

• Age ≥ 18 years.
• Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).
• Symptomatic, defined as a TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment at a Screening visit.
• Anemic, defined as a Hgb < 10 g/dL in Screening/Baseline period.
• Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of ≥ 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.
• Baseline splenomegaly, defined as having a palpable spleen at ≥ 5 cm, below the left costal margin, or with volume ≥ 450 cm³ on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization.
• High risk, intermediate-2, or intermediate-1 risk MF as defined by DIPSS, or DIPSS-plus.
• No allogeneic stem cell transplant planned.

Exclusion criteria

• Use of the following treatments within the time periods noted:

  • Prior momelotinib treatment at any time.
  • JAK inhibitor therapy within 2 weeks prior to Randomization.
  • Active anti-MF therapy within 2 weeks prior to Randomization.
  • Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization.
  • Investigational agent within 4 weeks prior to Randomization.
  • Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.
  • Danazol within 3 months prior to Randomization.
  • Splenic irradiation within 3 months prior to Randomization.
  • Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.

Participating sites

• ZNA Antwerpen