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

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.

Conditions

Primary Immune Thrombocytopenia (ITP)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Primary Immune Thrombocytopenia (ITP)
Intervention / Treatment

-

Contacts and Locations

Yuma

Yuma Regional Medical Center, Yuma, Arizona, United States, 85349

Clovis

Community Cancer Institute, Clovis, California, United States, 93611

Fountain Valley

Compassionate Care Res Group Inc, Fountain Valley, California, United States, 92708

Aurora

University of Colorado Anschutz, Aurora, Colorado, United States, 80045

Margate

Napa Research, Margate, Florida, United States, 33063

Tampa

New Tampa Health, Tampa, Florida, United States, 33603

Chicago

Uni of Chi Medi Ctr Hema and Onco, Chicago, Illinois, United States, 60637

Fort Wayne

Parkview Research Center, Fort Wayne, Indiana, United States, 46845

Bethesda

Oncology Care Associates, Bethesda, Maryland, United States, 20817

Farmington Hills

Michigan Center of Medical Research, Farmington Hills, Michigan, United States, 48334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-12-18