Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thr… (NCT05653349) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
United States226 participantsStarted 2023-02-03
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 low grade 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.
What they're measuring
1
Time from randomization to treatment failure (TTF)
Timeframe: Randomization to end of study (up to 39 months after randomization of last patient)