A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids

A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment - VAYHIT2/CVAY736Q12301

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220623

Enrollment

Registered

2023-02-09

Start date

2023-08-14

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

Experimental: Treatment arm 1 Participants will receive eltrombopag and ianalumab lower dose Experimental: Treatment arm 2 Participants will receive eltrombopag and ianalumab higher dose Placebo Com

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18 years and older on the day of signing the informed consent. 2. A signed informed consent must be obtained prior to participation in the study. 3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy +/- IVIG. 4. Platelet count <30 G/L and assessed need for treatment (per physician's discretion).

Exclusion criteria

Exclusion criteria: 1. ITP patients who received second-line ITP treatments (other than steroid therapy +/- IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible. 2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia 3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters 4. Patients with current or history of life-threatening bleeding 5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive 6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period 7. Patients with hepatic impairment 8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication 9. Female patients who are pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ] Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: platelet count below 30 G/L start of a new ITP treatment need for a rescue treatment ineligibility to taper or inability to discontinue eltrombopag death	—

Measure

Time frame

Time from randomization until treatment failure [ Time Frame: Randomization to until end of study (up to 39 months after randomization of last participant) ] Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: platelet count below 30 G/L start of a new ITP treatment need for a rescue treatment ineligibility to taper or inability to discontinue eltrombopag death

—

Countries

Japan, Singapore

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