Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

Inclusion Criteria:

• Signed informed consent prior to participation in the study.

• Male or female participants aged 18 years and older on the day of signing informedconsent

• Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)

• Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)

• Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time priorto randomization. Note: Platelet count measured within 7 days of platelettransfusion will not be considered as response.

Key Exclusion Criteria:

• Evans syndrome or any other cytopenia (patients with low grade anemia related tobleeding or iron deficiency are eligible)

• Current life-threatening bleeding

• Previous ITP treatment, including splenectomy, except for corticosteroids and/orIVIG initiated as first-line therapy for up to 28 days before randomization andrescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .

• Prior use of B-cell depleting therapy (e.g., rituximab).

• Absolute neutrophil count below 1.0 G/L at randomization

• Participants with concurrent coagulation disorders and/or receiving anti-platelet oranticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.