A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05653349Tipo: INTERVENTIONALInicio: 3 de feb de 2023Fin estimado: 7 de sept de 2028

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

Ianalumab

Intravenous infusion, prepared from concentrate solution

drug

Placebo

Intravenous infusion, prepared from matching placebo

drug

Corticosteroids

Oral or parental (if clinically justified)

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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