ACTIVE_NOT_RECRUITING

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

Conditions

Primary Immune Thrombocytopenia (ITP)ianalumab VAY736 B-cell depletion B-cell Activating Factor Receptor (BAFF-R) blockade

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-06

Study Completion:2028-12-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05653349

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.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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

Inclusion Criteria

Exclusion 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 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

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Yuma Regional Medical Center

Yuma, Arizona, 85349

United States

Community Cancer Institute

Clovis, California, 93611

United States

Compassionate Care Res Group Inc

Fountain Valley, California, 92708

United States

University of Colorado Anschutz

Aurora, Colorado, 80045

United States

Napa Research

Margate, Florida, 33063

United States

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, 60637

United States

Parkview Research Center

Fort Wayne, Indiana, 46845

United States

Oncology Care Associates

Bethesda, Maryland, 20817

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Med Center

Boston, Massachusetts, 02215

United States

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334

United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905

United States

Metro Minnesota CCOP

Saint Louis Park, Minnesota, 55416

United States

St Vincent Frontier Cancer Center

Billings, Montana, 59102

United States

Clinical Research Alliance

Lake Success, New York, 11042

United States

Hematology Oncology Association of Rockland

Nyack, New York, 10960

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

STAT Research Inc

Dayton, Ohio, 45402

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Mays Cancer Ctr Uthsa Mdacc

San Antonio, Texas, 78229

United States

Community Cancer Trials of Utah

Ogden, Utah, 84405

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-06

Study Completion Date2028-12-18

Study Record Updates

Study Start Date2023-03-06

Study Completion Date2028-12-18

Terms related to this study

Keywords Provided by Researchers

Primary immune thrombocytopenia (ITP)
ianalumab
VAY736
B-cell depletion
B-cell Activating Factor Receptor (BAFF-R) blockade

Additional Relevant MeSH Terms

Primary Immune Thrombocytopenia (ITP)