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 informed
consent.

- 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 not
need to be the last treatment.

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

- At last ITP treatment, loss of response, insufficient response, no response or
intolerance.

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

Key exclusion criteria:

- Diagnosis of secondary thrombocytopenia.

- Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue
medications 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-cell
Activating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks prior
to the first administration of ianalumab.

- Immunosuppressant drugs other than corticosteroids within 5 times the elimination
half-life of the drug or 14 days before first ianalumab infusion, whichever is
longer.

- Prior splenectomy.

Other protocol-defined inclusion/exclusion criteria may apply.