A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia

A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia - VAYHIT1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061220095

Enrollment

Registered

2023-02-09

Start date

2023-06-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary immune thrombocytopenia

Interventions

Arm A: Ianalumab 3 mg/kg intravenously every 4 weeks plus corticosteroid administered orally or parenterally if clinically justified Arm B: Ianalumab 9 mg/kg intravenously every 4 weeks plus corticost

Eligibility

Sex/Gender

All

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Time from randomization to Treatment Failure (TTF) defined as platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, start of a second-line therapy or death (whatever the cause).	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Romania, Singapore, Spain, Thailand, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactKyosuke Yamauchi

Novartis Pharma. K.K.

rinshoshiken.toroku2@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026