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

• Status: Not yet recruiting
• Trial end date: 2028-03-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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 informed consent

• 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 prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.

Key Exclusion Criteria:

• Evans syndrome or any other cytopenia

• Current life-threatening bleeding

• Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG for up to 28 days before randomization.

• 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 or anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.