Pelt

Researchers are investigating how people with multiple sclerosis (MS) perceive their motor performance compared to healthy individuals. The study focuses on understanding perceptive abilities during prolonged functional tasks like walking and repeatedly standing up from a seated position. By comparing self-reported perceptions and actual performance, the study aims to identify specific deficits in people with MS that could help tailor additional interventions beyond standard care. Participants will complete two main experimental tasks over a maximum of three days. The first task involves walking at maximum speed for six minutes and reporting perceived changes in speed or smoothness using a handheld haptic device. The second task requires repeated sit-to-stand transitions at a fixed pace, again reporting perception changes. A second work package includes treadmill walking with imposed speed changes and sit-to-stand transitions with adjustable chair heights to assess perceptive accuracy for externally imposed variations. Wearable sensors will objectively record motor performance during all tasks. During the study, participants will provide demographic information and complete questionnaires on physical activity, sleep, self-efficacy, mood, symptoms, fatigue, and body perception. Motor and cognitive tests will be performed, including walking speed, balance, memory, and proprioception assessments. Fatigue levels will be measured before and after tasks. Researchers will compare reported perceptions with actual performance to assess sensitivity, detection accuracy, and correspondence accuracy in motor tasks.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.

Researchers are evaluating the efficacy, safety, and tolerability of remibrutinib in people living with relapsing multiple sclerosis (RMS). This Phase 3b study compares remibrutinib after switching from ocrelizumab to continuous ocrelizumab treatment. It aims to provide important data on how well remibrutinib works and how safe and tolerable it is for patients with RMS. Participants are randomly assigned to receive either remibrutinib tablets taken daily or ongoing ocrelizumab infusions or injections at standard doses (600mg infusion or 920mg injection). The study includes an initial Core Part lasting up to 24 months, followed by an Extension Part lasting up to 24 months where eligible participants continue open-label treatment with remibrutinib. The study is conducted at multiple centers, including locations in the USA and worldwide. During the study, participants will be monitored regularly with assessments that include brain MRI scans to measure the annualized rate of new or enlarging T2 lesions. Researchers will also evaluate safety and tolerability throughout both study parts. Those completing the Core Part may join the Extension Part to continue receiving remibrutinib for long-term observation. The total study duration for participants can be up to 48 months.

Pre-eclampsia (PE) is a pregnancy condition marked by high blood pressure (greater than 140/90 mm Hg) and significant protein in the urine after 20 weeks of pregnancy. It affects about 5-8% of pregnant women worldwide and can lead to serious complications for both the mother and child if left untreated. Researchers are investigating cardiovascular changes during pregnancy to improve early detection and treatment of PE, focusing on women at high risk. This study involves pregnant women starting at 10 weeks of pregnancy. At 10 and 20 weeks, participants will have several measurements including NICCOMO (an impedance cardiograph), Maternal Venous Doppler Echography, Maltron bio-electronic impedance analysis, blood pressure, activity tracking, and weight monitoring. If abnormal results appear at 20 or 30 weeks, participants will join a remote monitoring program using devices such as a wireless blood pressure monitor (twice daily), an activity tracker (day and night), and a smart body analyzer for weight (once daily). Participants will be monitored through repeated assessments at 10, 20, and potentially 30 weeks of pregnancy. These include heart and vein imaging, blood pressure checks, activity tracking, and weight measurements. The study aims to track cardiovascular health and detect early signs of PE. Up to 2000 pregnant women from eight hospitals will take part, with ongoing remote monitoring for those showing abnormal test results to support intensive follow-up and care.

Researchers are evaluating subcutaneous (SC) administration of frexalimab every 4 weeks compared to intravenous (IV) administration every 4 weeks in adults aged 18 to 60 years with relapsing multiple sclerosis (RMS) or non-relapsing secondary progressive multiple sclerosis (nrSPMS). This is a Phase 3, randomized, open-label study aiming to assess the pharmacokinetics, safety, and efficacy of these two methods of frexalimab delivery in male and female participants who meet strict inclusion criteria and have not been excluded by specific health conditions. Participants will receive frexalimab either by SC injection or IV infusion, with study intervention lasting 48 weeks across Parts A and B. An optional Part C will continue until the start of a long-term safety study for frexalimab. The study includes monthly visits from Week 4 to Week 24 in Part A, then visits every 1 to 3 months in Part B, and every 6 months in Part C. Participants stopping treatment early will have three additional follow-up visits. MRI contrast-enhancing agents will be administered via IV injection as part of the study procedures. During the study, participants will undergo regular visits for assessments including pharmacokinetic measurements such as trough concentration at steady state and area under the curve from Week 20 to Week 24. Safety and efficacy will be monitored through clinical evaluations, MRI scans, and laboratory tests. Follow-up after study intervention will continue for 6 months to ensure ongoing safety and monitor long-term outcomes, with a total of up to 17 visits for SC administration and 11 visits for IV administration.