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Evaluating ianalumab with corticosteroids for treating 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)

Phase 3 Interventional Novartis · NCT05653349

This study is testing if a new drug called ianalumab can help adults with primary immune thrombocytopenia maintain healthy platelet levels when used with standard corticosteroids.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsrituximab, ianalumab
Locations152 sites (Yuma, Arizona and 151 other locations)
Trial IDNCT05653349 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy and safety of two doses of ianalumab compared to a placebo in adult patients with primary immune thrombocytopenia (ITP) who are receiving first-line corticosteroid treatment. Participants will be randomly assigned to receive either ianalumab or placebo alongside standard corticosteroids, with the primary goal of maintaining a platelet count of at least 30 G/L. The study will include a screening period followed by a treatment phase, and participants will be monitored for efficacy and safety outcomes during a follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary ITP within the last three months and having a platelet count below 30 G/L.

Not a fit: Patients with Evans syndrome, life-threatening bleeding, or those who have previously undergone ITP treatments other than corticosteroids or IVIG may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with primary immune thrombocytopenia, potentially improving platelet counts and reducing the need for more invasive treatments.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting B-cell depletion in ITP, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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 (patients with low grade 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

Other protocol-defined Inclusion/Exclusion may apply.

Where this trial is running

Yuma, Arizona and 151 other locations

+102 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Immune ThrombocytopeniaPrimary immune thrombocytopeniaianalumabVAY736B-cell depletionB-cell Activating Factor Receptor blockade
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.