Purpose

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.

Category

IRB Number
STUDY00000136
NCT Number
-
Sponsor
-



Study Contact

Principal Investigator
Elizabeth Bowhay-Carnes

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



Eligibility

Eligible Ages
18-
Eligible Genders
all
Accepts Healthy Volunteers
No

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