Farmington

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 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.

A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.

Researchers are evaluating a modified regimen of ublituximab in adults with relapsing multiple sclerosis (RMS) to assess its effectiveness and safety. The study is a phase 3b trial consisting of three parts: Part A is open-label and single-arm, Part B is randomized, double-blind, and placebo-controlled, and Part C is open-label focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The main goal is to measure changes in T1 Gadolinium-enhancing lesions in the brain to see how well the treatment works. Participants receive ublituximab or placebo through intravenous (IV) infusions during different parts of the study. Part A and Part C involve ublituximab infusions, while Part B compares ublituximab to placebo infusions. Part C includes participants who have been treated with an anti-CD20 agent for at least six months but had suboptimal results and meet specific washout requirements before beginning this study. During the study, participants undergo regular assessments, including brain MRI scans to monitor T1 Gd-enhancing lesions over 48 weeks and pharmacokinetic measurements up to 16 weeks. Researchers also evaluate safety and treatment responses throughout the study. The trial includes adults aged 18 to 65 with stable neurological status and a disability score of 5.5 or less. Female participants of childbearing potential must use contraception during and after the study. Total participation time varies based on the study part and treatment schedule.