Smyrna

This research aims to understand how the drug BRIUMVI™ (Ublituximab) appears and at what concentration it is present in the breast milk of breastfeeding individuals who are receiving this treatment for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. The study focuses on participants who have decided to use BRIUMVI™ therapeutically and are breastfeeding during the study period. Participants will receive BRIUMVI™ as part of their regular treatment, with no additional interventions applied by the study. Breastfeeding or regular pumping is required to maintain milk supply and to collect breast milk samples, particularly during a 24-hour period on the first day after the intravenous dose. The study involves monitoring breast milk at multiple timepoints including Day 1 (before dose) and several points up to Day 90 post-dose to measure drug concentration. During the study, breast milk samples will be collected and analyzed for various measures of BRIUMVI™ concentration, such as total exposure over time (area under the curve), peak concentration, and concentration at the end of dosing intervals. Mothers and their infants will be monitored for health and safety, with data collected on breastfeeding patterns and milk supply. The total duration of participation covers multiple follow-up points up to 90 days to thoroughly evaluate drug presence in breast milk.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating a Vaginal Cooling Device (VCD) to treat women aged 22 to 49 with vulvovaginal candidiasis (VVC), also known as yeast vaginitis. The study aims to determine the clinical cure rate and safety of this device. Additionally, it will assess the safety, mycological cure rates, speed and effectiveness of symptom relief, vaginal hyphae and polymorphonuclear (PMN) cell scores, and quality-of-life measures related to the treatment. The investigational treatment involves using a vaginal cooling device made of medical-grade polymer filled with an inert fluid (15 cc). This open-label, uncontrolled study includes women diagnosed with uncomplicated VVC who will use the device as directed. The study focuses on observing the device's impact on symptoms and infection resolution over a treatment period. Participants will be evaluated through clinical and laboratory tests including a positive KOH wet mount and yeast culture at baseline. They will be monitored for clinical cure at around 7 days after treatment. Additional assessments include vaginal signs and symptoms, quality-of-life questionnaires, and safety evaluations. Participants will also use a smartphone app to support study procedures and will be asked to avoid sexual activity during the study period. The total involvement lasts through initial diagnosis, treatment, and follow-up assessments.

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.