Pelt

Researchers are evaluating the effects of remibrutinib compared to continuous ocrelizumab treatment in people living with relapsing multiple sclerosis RMS. This Phase 3b study aims to provide data on the efficacy, safety, and tolerability of remibrutinib when patients switch from ocrelizumab. The trial is randomized, open-label, and conducted across multiple centers globally, including the USA. Participants in the study are assigned to either switch to remibrutinib tablets taken orally or continue with ocrelizumab administered via infusion or injection at standard doses. The study includes a Core Part lasting up to 24 months, during which these treatments are compared. Those completing the Core Part may enter an Extension Part lasting up to 24 months, where all participants receive remibrutinib in an open-label format. Throughout the study, participants will undergo regular monitoring including MRI scans to measure new or enlarging T2 lesions and assessments for disease activity and adverse events. The main outcome is the annualized rate of new or enlarging T2 lesions during the Core Part, with continued evaluations during the Extension Part. Safety and tolerability are closely monitored, and total participation can last up to 48 months.

Pregnancy involves many changes in the cardiovascular system, but in pre-eclampsia PE, these changes are abnormal. PE affects 5 to 8 percent of pregnant women worldwide and is marked by high blood pressure and protein in the urine after 20 weeks of pregnancy. If not treated, PE can cause serious problems for both mother and baby. This research focuses on better monitoring and early detection of PE in high-risk pregnant women. The study compares two groups a control group receiving no intervention, and a remote monitoring group using special devices. At 10 weeks of pregnancy, all participants receive measurements with NICCOMO, maternal venous Doppler echography, and Maltron bio-electronic impedance analysis. These tests repeat at 20 weeks, and at 30 weeks if results are abnormal. The remote monitoring group uses devices to check blood pressure twice daily, activity continuously, and weight once daily. Participants will be monitored throughout their pregnancy with repeated tests and device tracking. Researchers will check blood pressure, heart and vein function, body measurements, activity levels, and weight at specific times. They will also collect birth-related information like birth weight, gestational age, delivery method, and timing. The study includes 2000 pregnant women and aims to improve follow-up and care for those at risk of PE.

Researchers are evaluating the differences between subcutaneous SC and intravenous IV administration of frexalimab in adults aged 18 to 60 years with relapsing multiple sclerosis RMS and non-relapsing secondary progressive multiple sclerosis nrSPMS. This Phase 3, randomized, open-label study aims to compare the pharmacokinetics, safety, and efficacy of these two methods of delivering frexalimab over a one-year period. Participants include males and females diagnosed with MS who meet specific clinical criteria related to their disease type and progression. Participants will be randomly assigned to receive frexalimab either as an SC injection every 4 weeks using a home self-administration on-body delivery system after training and agreement starting from Part B or as an IV infusion every 4 weeks. The treatment duration covers 48 weeks for the first two parts of the study, with an optional third part continuing until the start of a long-term safety study. Regular visits occur monthly between weeks 4 and 24, then less frequently up to the end of the study, with follow-up visits for those who discontinue treatment early. During the study, participants will attend up to 17 scheduled visits and undergo assessments including MRI scans with contrast, blood tests to measure drug levels and immune responses, and evaluations of disability progression. Researchers will monitor adverse events, the presence of antibodies to the drug, and participant preferences for SC versus IV administration. Follow-up continues for six months after treatment ends to assess long-term safety and outcomes. The study collects data on pharmacokinetics and clinical effects at multiple timepoints up to week 96 and beyond for some participants.