Smyrna

This research aims to understand how much BRIUMVI ublituximab, a treatment used for relapsing multiple sclerosis RMS, is present in the breast milk of breastfeeding women who receive this therapy. The study focuses on women diagnosed with RMS, including forms like clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Researchers want to see how BRIUMVI passes into breast milk over time to better understand exposure to nursing infants. Participants who are already being treated with BRIUMVI will have their breast milk collected for up to 24 hours after receiving their dose. Milk samples will be taken at multiple time points from before treatment and up to 90 days after dosing to measure the concentration of BRIUMVI. The study does not involve giving the drug as part of the trial but observes those receiving it as part of their routine care. During the study, participants will provide breast milk samples at scheduled times, including on Day 1 before dosing and several days afterward up to Day 90. The research team will analyze these samples to measure BRIUMVI levels and calculate various pharmacokinetic measures like area under the curve and maximum concentration. Infant health will also be monitored for adverse events during the study and up to 3 months after the dose. The total study duration for each participant spans about three months following the dose.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

Researchers are evaluating the clinical cure rate and safety of a specialized Vaginal Cooling Device VCD in women with uncomplicated vulvovaginal candidiasis VVC, a yeast infection affecting the vagina. The study also aims to assess the safety, fungal cure rates, speed and effectiveness of symptom relief, vaginal hyphae and immune cell counts, as well as quality-of-life measures related to VVC. Participants will use the vaginal cooling device, which is a medical-grade polymer capsule filled with inert fluid, twice daily for 30 minutes each time over three days, totaling 3 hours of use. This open-label, uncontrolled study involves women aged 22 to 49 who have confirmed VVC. There is no placebo or comparison group, and the device use is monitored to evaluate its effects. Women in the study will undergo clinical diagnosis and confirmation of VVC by laboratory tests at baseline. Researchers will monitor the number of clinical cures at 7 days, with follow-up at 28 days to assess ongoing cure rates. Participants will avoid vaginal sexual activity during the study and use a smartphone app to support study procedures. Safety, symptom resolution, and quality-of-life changes will be closely tracked throughout the study period, which concludes by June 2026.

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.