Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

Inclusion criteria:

Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria (IPSS) (according to Cervantes F. et. al.; at screening).
Enlarged spleen, palpable at least 5 cm below costal margin.
At least 18 years of age.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
The following laboratory values within 14 days prior to the initiation of IMP or placebo:
Absolute Neutrophil Count (ANC) ≥1.0 x 10exp9/L
Platelet count ≥50 x 10exp9/L
Serum creatinine ≤1.5 x Upper Limit of Normal (ULN)
Serum amylase and lipase ≤1.5 x ULN

Exclusion criteria:

Splenectomy.
Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
Known active (acute or chronic) Hepatitis A, B, or C; and hepatitis B and C carriers
AST or ALT ≥2.5 x ULN
Total Bilirubin:
Exclude if ≥3.0 x ULN
Patients with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total
Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH])

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.