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New treatment option for Primary Immune Thrombocytopenia (ITP)
Official title 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)
ClinicalTrials.gov ID: NCT07421167
What this study is testing
What is ianalumab?
ianalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Also referred to as VAY736.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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 \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stamford, Connecticut, United States
- Jacksonville, Florida, United States
- Margate, Florida, United States
- Hinsdale, Illinois, United States
- Summit, New Jersey, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stamford, Connecticut, United States; Jacksonville, Florida, United States; Margate, Florida, United States; Hinsdale, Illinois, United States; Summit, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.