• Age ≥ 18 years old at the time of enrolment.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

• Expected life expectancy ≥ 3 months.

• Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of \< 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.5.

• Ability to undergo the study-required bone marrow sample collection procedures.

• Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).

• Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.

• Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 180 days after the last dose of the study treatment.

• Unsterilized male patients having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until 180 days after the last dose of study treatment.