Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Purpose
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.
Condition
- Primary Immune Thrombocytopenia (ITP)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ianalumab Lower dose |
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified) |
|
|
Experimental Ianalumab Higher dose |
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified) |
|
|
Placebo Comparator Placebo |
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified) |
|
Recruiting Locations
Mays Cancer Ctr Uthsa Mdacc UTHSCSA
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
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.