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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.
EU CTIS ID: 2024-512890-28-00
What this study is testing
To demonstrate that the addition of ianalumab (either dose) to standard of care, eltrombopag, prolongs Time to Treatment Failure (TTF) compared to eltrombopag alone in participants with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients aged 18 years and older on the day of signing the informed consent.
- A signed informed consent must be obtained prior to participation in the study
- A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
- Patients with platelet count <30 G/L for whom eltrombopag is clinically indicated as per physician’s discretion and with no contraindication to receive eltrombopag.
You likely can't join if
- ITP patients who received second-line ITP treatments (other than corticosteroid therapy ± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonist (TPO-RAs) for a limited time (max. one week) before screening are eligible.
- Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible).
- Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters.
- Patients with current or history of life-treating bleeding.
- Patients that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)- positive.
- Patients with known active or uncontrolled infection requiring systemic treatment during screening period.
See the full eligibility criteria
- Male or female patients aged 18 years and older on the day of signing the informed consent.
- A signed informed consent must be obtained prior to participation in the study
- A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
- Patients with platelet count <30 G/L for whom eltrombopag is clinically indicated as per physician’s discretion and with no contraindication to receive eltrombopag.
- ITP patients who received second-line ITP treatments (other than corticosteroid therapy ± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonist (TPO-RAs) for a limited time (max. one week) before screening are eligible.
- Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible).
- Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters.
- Patients with current or history of life-treating bleeding.
- Patients that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)- positive.
- Patients with known active or uncontrolled infection requiring systemic treatment during screening period.
- Patients with hepatic impairment with Child-Pugh score >5
- Patients with concurrent coagulation disorder and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily).
- Nursing (breast feeding) or pregnant women.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Turkey
- Taiwan
- China
- Argentina
- Japan
- Thailand
- Australia
- Philippines
- Malaysia
- Singapore
- Korea, Republic of
- Mexico
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Turkey; Taiwan; China; Argentina; Japan and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.