Find-A-Study

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

Lay Description

To demonstrate that the addition of ianalumab (VAY736, either dose) to standard first-line corticosteroids prolongs
Time to Treatment Failure (TTF) compared to corticosteroids alone in participants with primary immune
thrombocytopenia (ITP) who responded to corticosteroids (+/- IVIG) prior to randomization.

Eligibility

Eligible Ages: 18-
Eligible Genders: all
Accepts Healthy Volunteers

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 therpay (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 counts 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
active viral, bacterial or other infections requiring systemic treatment or SARS-CoV-2 infection during the treatment period, or history of recurent clinically significant infection
participants who are hepatitis C virus antibody, hepatitis B surface antigen positive
known history of primary or secondary immunodeficiency or a positive HIV test result
live or live-attenuated vaccination within 4 weeks before randomization
nursing or pregnancy at screening or pre-dose on Day 1
women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after last dose of ianalumab
previous or concurrent malignancy except for curatively treated non-melanoma skin cancer, in situ cancer, and cancer in complete remission for at least 3 years and without evidence of remission
any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with particpants' safety and efficacy, obtaining informed consent or compliance with the study procedures as per investigator discretion
known immediate or delayed hypersensitivity reaction or idiosyncrasy to ianalumab or drugs chemically related to ianalumab or excipients that contraindicate their participation
concurrent participation in an investigational study within 3 days prior to randomization or within 5 half lives of the investigational product, whichever is longest. Note: parallel enrollment in a disease registry is permitted.

Study Design

Arm Groups

Study Contact

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Jessica Villarreal

villarreal24@uthscsa.edu

Epp Goodwin
210-450-5798
goodwine@uthscsa.edu

Principal Investigator
Elizabeth Bowhay-Carnes