A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
A legfontosabb adatok
- Hol
- Boston (Egyesült Államok)Mind a 2 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Beth Israel Deaconess Med CenterBoston, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Novartis Pharmaceuticals
- Azonosító
- NCT05885555EU 2022-503041-21-00
- A regiszteradat frissítve
- 2026. október 20.
- Eredeti leírás
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.A teljes eredeti leírásKevesebb
A Phase 2 Study to Evaluate the Efficacy and Safety of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least a Corticosteroid and a Thrombopoietin Receptor Agonist (TPO-RA)
The purpose of this study is to evaluate the therapeutic efficacy, safety and tolerability of ianalumab in adult patients with primary ITP previously treated with at least one corticosteroid and one TPO-RA.
Bevonási feltételek: Signed informed consent obtained prior to participation in the study; Male or female participants aged 18 years and older on the day of signing informed consent; Confirmed diagnosis of primary ITP; Prior treatment with at least a corticosteroid (±IVIG) and a TPO-RA:; Prior additional therapies are allowed; the corticosteroid or the TPO-RA do not need to be the last treatment; Prior response to IVIG/anti-D or a corticosteroid (platelet count ≥50 G/L) that was not maintained; At last ITP treatment, loss of response, insufficient response, no response or intolerance; Platelet count <30 G/L and assessed as needing treatment (per physician's discretion) at screening. If concomitant ITP medication is clinically indicated, the platelet assessment showing a value <30 G/L must be performed after at least 14 days on a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation from current dose) and continue stable thereafter.
Kizáró feltételek: Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cell Activating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks prior to the first administration of ianalumab; Immunosuppressant drugs other than corticosteroids within 5 times the elimination half-life of the drug or 14 days before first ianalumab infusion, whichever is longer; Prior splenectomy; Other protocol-defined inclusion/exclusion criteria may apply; Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue medications within 14 days before first ianalumab infusion; Participants with the following conditions at screening:; Neutrophils <1000/mm3; Immunoglobulin G (IgG) <5 g/L; Diagnosis of secondary thrombocytopenia.