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

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

ClinicalTrials.gov Identifier: NCT05653349

Novartis Reference Number: CVAY736I12301

Last Update: Jan 19, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study 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.

Condition

Primary Immune Thrombocytopenia (ITP)

Phase

Phase 3

Overall status

Recruiting

Start date

Jan 30, 2023

Completion date

Apr 13, 2028

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Biological

Ianalumab

Intravenously infusion, prepared from concentrate solution

Drug

Placebo

Intravenously infusion, prepared from matching placebo

Drug

Corticosteroids

Oral or parentally (if clinically justified)

Eligibility Criteria

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 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.

Key Exclusion Criteria:

Evans syndrome or any other cytopenia
Current life-threatening bleeding
Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG for up to 28 days before randomization.
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.