Study Description
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. This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and
safety of two different doses of ianalumab compared to placebo in adults with primary ITP
(platelets count <30 G/L) who require first-line standard-of-care corticosteroids.
After completion of the screening period, the participants will enter the randomized
treatment period (ianalumab/placebo with standard of care corticosteroids).
After the treatment period, all participants will enter the follow-up period to be
monitored for efficacy and safety or safety only depending on how they respond to the
study treatment.
Interventions
Corticosteroids
Ianalumab
Placebo
Eligibility 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 (patients with anemia related to bleeding or
iron deficiency are eligible)
- Current life-threatening bleeding
- Previous ITP treatment, including splenectomy, except for corticosteroids and/or
IVIG initiated as first-line therapy for up to 28 days before randomization and
rescue 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 or
anticoagulant medication with an exemption of low dose of acetylsalicylic acid
Other protocol-defined Inclusion/Exclusion may apply.
Worldwide Contacts
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