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NCT07421167From ClinicalTrials.govRecruiting

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)

A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)

  • Primary Immune Thrombocytopenia (ITP)
  • Primary Evans Syndrome (ES)

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
164
Started
4 August 2026
Main results due
18 January 2029
Study sites
15
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Key Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Patients aged 18 years and older on the day of signing the informed consent.
* ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G/L).
* ITP cohort only: Received at least one prior treatment for ITP.
* ITP cohort only: Patients with a platelet count \< 100 G/L who are receiving a TPO-RA. Patients may already be receiving a TPO-RA or may start a TPO-RA at the time of screening. All patients should be on a stable dose of TPO-RA for at least 14 days prior to first dose of ianalumab. Note: during the screening period, a documented assessment of platelets \< 100 G/L is mandatory for enrollment. For patients who received rescue medication before screening, platelet count results obtained prior to the start of the rescue therapy should be used to assess eligibility if collected within 14 days prior to screening.
* ES cohort only: Patients with clinical diagnosis of primary ES with active thrombocytopenia (\< 100 G/L) with warm autoimmune hemolytic anemia (wAIHA) for whom a TPO-RA is appropriate per Investigator.
* ES cohort only: Inadequate response to or relapse after treatment with corticosteroid therapy.
* ES cohort only: Diagnosis confirmed by current or past positive direct antiglobulin test (DAT) (IgG+, with or without C3+) and evidence of hemolysis.
* ES cohort only: any supportive care treatment administered for wAIHA must be stable for at least 4 weeks prior to enrollment.

Key Exclusion Criteria:

* Patients being treated with TPO-RA for \> 6 months.
* Current life-threatening bleeding (related to thrombocytopenia).
* Prior splenectomy within 6 months of first administration of ianalumab.
* Patients with the following laboratory abnormalities:

  * Neutrophils: \< 1000/mm3
  * Serum creatinine \> 1.5 × upper limit of normal (ULN)
  * Aspartate aminotransferase (AST) \> 3.0 × ULN
  * Alanine aminotransferase (ALT) \> 3.0 × ULN
  * Immunoglobulin G (IgG) \< 5 g/L
  * ITP cohort only: hemoglobin \< 10 g/L, total bilirubin \> 1.5 × ULN
* Patients with significantly compromised liver disease (Child-Pugh 7 to 9) and decompensated liver disease (Child-Pugh 10 to 15).
* Treatment with a B-cell depleting therapy (e.g. rituximab or anti-B cell Activating Factor (e.g. belimumab) within 12 weeks prior to the first administration of ianalumab. Patients who are refractory to rituximab will be excluded from this trial, where refractory is defined as:

  \~ Patients who have not achieved a response (defined as platelet count ≥ 30 G/L and at least doubling from baseline within 12 weeks in the absence of rescue therapy) following completion of a standard course of rituximab
* History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
* Known history of primary or secondary immunodeficiency, or a positive human immunodeficiency virus (HIV) enzyme-linked immunosorbent assay (ELISA) and Western blot) test result.
* Patients exposed to more than 4 prior treatments for ITP.
* ITP cohort only: Diagnosis of secondary thrombocytopenia.
* ITP cohort: Use of immunosuppressant drugs other than corticosteroids or rituximab.
* ES cohort only: Diagnosis of secondary ES.
* ES cohort only: Life-threatening hemolysis.
* ES cohort only: patients with autoimmune hemolytic anemia other than wAIHA

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.

Study sites(15)

  • Highlands Oncology Group

    Fayetteville, Arkansas, United States

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, United States

    Recruiting

  • Stamford Hospital

    Stamford, Connecticut, United States

    Recruiting

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, United States

    Recruiting

  • DH Cancer Research Center LLC

    Margate, Florida, United States

    Recruiting

  • University Of Miami

    Miami, Florida, United States

    Recruiting

  • Hope And Healing Care

    Hinsdale, Illinois, United States

    Recruiting

  • Pontchartrain Cancer Center

    Covington, Louisiana, United States

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, United States

    Recruiting

  • Intermountain Healthcare

    Billings, Montana, United States

    Recruiting

  • Astera Cancer Center

    East Brunswick, New Jersey, United States

    Recruiting

  • Summit Medical Group

    Summit, New Jersey, United States

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, United States

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, United States

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, United States

    Recruiting

Showing 15 of 15 sites. 15 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07421167. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Ag | Trialion