Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Key facts
- Where
- Aurora, Boston, Chicago, Clovis, Fort Wayne, Fountain Valley, Margate, Nyack, Ogden, Providence, Rochester, San Antonio, and Yuma, United StatesSee the 14 sites
- Phase
- Phase 3
Where in United States
- University of Colorado AnschutzAurora, United StatesNo longer taking part
- Beth Israel Deaconess Med CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Uni of Chi Medi Ctr Hema and OncoChicago, United StatesNo longer taking part
- Community Cancer InstituteClovis, United StatesNo longer taking part
- Parkview Research CenterFort Wayne, United StatesNo longer taking part
- Compassionate Care Res Group IncFountain Valley, United StatesNo longer taking part
- DH Cancer Research Center LLCMargate, United StatesNo longer taking part
- Hematology Oncology Association of RocklandNyack, United StatesNo longer taking part
- Community Cancer Trials of UtahOgden, United StatesNo longer taking part
- Rhode Island HospitalProvidence, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- Mays Cancer Ctr Uthsa MdaccSan Antonio, United StatesNo longer taking part
- Yuma Regional Medical CenterYuma, United StatesNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT05653349EU 2024-511704-17-00
- Record updated
- 12 November 2026
- Original description
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.Read full original descriptionShow less
A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.
Inclusion: 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.
Exclusion: 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); Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible); Current life-threatening bleeding; 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.