Publications by authors named "Vladimir Son"
Background: Ozanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treatment of moderately to severely active ulcerative colitis and relapsing multiple sclerosis, showed clinical, endoscopic, and histological benefit in the phase 2 STEPSTONE trial for Crohn's disease (CD). We aim to describe the trial design of the YELLOWSTONE phase 3 program evaluating the safety and efficacy of ozanimod in patients with moderately to severely active CD.
Methods: The YELLOWSTONE program consists of phase 3, randomized, double-blind, placebo-controlled induction (NCT03440372 and NCT03440385) and maintenance (NCT03464097) trials and an open-label extension (OLE) study (NCT03467958).
Background: Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known.
Methods: In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis.
Article Synopsis
- Evinacumab, an antibody targeting lipid levels, was tested for its safety and effectiveness in both Japanese and Caucasian adults with increased cholesterol levels in a Phase 1 study.
- Evinacumab showed a similar safety profile to placebo, with no severe adverse events reported and similar pharmacokinetics across both ethnic groups.
- The treatment led to significant reductions in LDL-C and triglycerides, with effects seen as early as day 2 and sustained up to week 8 for both intravenous and subcutaneous doses.
Purpose: To compare the efficacy and safety of intravitreal aflibercept + anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).
Design: Phase 2, randomized, double-masked study.
Participants: A total of 505 patients (eyes) with nAMD.