Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

Inclusion Criteria:

- Diagnosis of essential thrombocythemia according to revised World Health Organization
(WHO) 2016 criteria.

- Resistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the
following criteria:

- Platelet count > 600 × 10^9/L after 3 months of at least 2 g/day of hydroxyurea
(2.5 g/day in subjects with a body weight over 80 kg) OR at the subject's
maximally tolerated dose if that dose is < 2 g/day.

- Platelet count > 400 × 10^9/L and WBC count < 2.5 × 10^9/L or hemoglobin < 10
g/dL at any dose of hydroxyurea.

- Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any
dose of hydroxyurea.

- Hydroxyurea-related fever.

- Platelet count > 650 × 10^9/L at screening.

- WBC > 11.0 × 10^9/L at screening.

Exclusion Criteria:

- Subjects previously treated with anagrelide or JAK inhibitors.

- Inadequate liver function at screening and Day 1 (before drug administration) as
demonstrated by:

- Total bilirubin > 1.5 × upper limit of normal (ULN)

- Aspartate aminotransferase or alanine aminotransferase > 1.5 × ULN

- Hepatocellular disease (eg, cirrhosis)

- Inadequate renal function at screening as demonstrated by creatinine clearance < 40
mL/min calculated by Cockcroft-Gault equation.