12 results
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…
Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes
The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
The primary objective is to determine which of two commonly used drugs for preoperative management provides the best intraoperative hemodynamic control in patients undergoing resection of a PCC. Secondary Objective(s): o to identify other…
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
Primary (Efficacy):To evaluate the efficacy of magrolimab + azacitidine compared with that of azacitidine + placebo in previously untreated participants with intermediate/high/very high risk MDS by IPSS-R as measured by CR rateTo evaluate the…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…
The current study is designed to evaluate the preliminary safety and efficacy of BLU-263 in patients with AdvSM, including in those with high and very high-risk SM-AHN, in whom HMAs, and azacitidine specifically, are the standard of care. Dose…
• Primary Objective: To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 with regard to molecular response prior to further treatment (reinduction / HSCT)• Secondary Objectives:o To assess safety of…