A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies

Inclusion Criteria:

• Signed informed consent obtained prior to participation in the study.

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

• Confirmed diagnosis of primary ITP.

• Prior treatment with at least a corticosteroid (±IVIG) and a TPO-RA:

• Prior additional therapies are allowed; the corticosteroid or the TPO-RA do notneed to be the last treatment.

• Prior response to IVIG/anti-D or a corticosteroid (platelet count ≥50 G/L) thatwas not maintained.

• At last ITP treatment, loss of response, insufficient response, no response orintolerance.

• Platelet count <30 G/L and assessed as needing treatment (per physician'sdiscretion) at screening. If concomitant ITP medication is clinically indicated, theplatelet assessment showing a value <30 G/L must be performed after at least 14 dayson a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation fromcurrent dose) and continue stable thereafter.

Key exclusion criteria:

• Diagnosis of secondary thrombocytopenia.

• Platelet or whole blood transfusion, plasmapheresis, or use of any other rescuemedications within 14 days before first ianalumab infusion.

• Participants with the following conditions at screening:

• Neutrophils <1000/mm3.

• Immunoglobulin G (IgG) <5 g/L

• Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cellActivating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks priorto the first administration of ianalumab.

• Immunosuppressant drugs other than corticosteroids within 5 times the eliminationhalf-life of the drug or 14 days before first ianalumab infusion, whichever islonger.

• Prior splenectomy.

Other protocol-defined inclusion/exclusion criteria may apply.