Phase 2 Study of the Pharmacokinetics, Safety, and Relative Bioavailability of Subcutaneous Ublituximab via Autoinjector versus Syringe in Patients with Multiple Sclerosis

The primary objectives of this Phase 2 study in patients with multiple sclerosis are to evaluate the pharmacokinetics and safety of subcutaneous ublituximab administered at various injection sites, and to assess the relative bioavailability of the drug when delivered via an autoinjector device compared to a syringe. Secondary objectives include the evaluation of the pharmacokinetic profile and safety of subcutaneous ublituximab during the second part of the investigation.

This study involves 230 participants diagnosed with relapsing remitting multiple sclerosis. The study population includes both male and female patients within the age range of 18 to 65 years. Eligible individuals must demonstrate neurological stability for more than 30 days prior to screening and possess an expanded disability status scale score of 5.5 or less. Clinical requirements for inclusion include documented evidence of specific relapse history or the presence of a gadolinium-enhancing lesion within the year preceding screening. Female participants of childbearing potential are required to utilize effective contraception from the time of consent through six months following the final administration of the study drug.

This Phase 2, multicenter study is designed to evaluate the pharmacokinetics and safety of ublituximab administered via subcutaneous injection at different administration sites. A second component of the research aims to assess the relative bioavailability of the solution for injection when delivered using an autoinjector device compared to a syringe. The study involves patients diagnosed with multiple sclerosis. The research methodology includes a screening visit to confirm eligibility based on specific clinical criteria, such as an Expanded Disability Status Scale score of ≤ 5.5 and neurological stability. The primary endpoint is the incidence of treatment-emergent adverse events. The total duration of the trial is estimated to extend through July 2029. Participation involves study visits to monitor safety and pharmacological response, concluding with an end-of-study visit.

The experimental medication is ublituximab, provided as a solution for injection. The administered dose is 400 mg via subcutaneous injection. This study evaluates the pharmacokinetics and safety of the substance when administered using different injection sites and compares the relative bioavailability of an autoinjector device against a standard syringe.

The assessment of efficacy in this study of patients with multiple sclerosis is not specified. The investigation focuses on evaluating the pharmacokinetics and safety of ublituximab administered via subcutaneous injection. The primary endpoint is the incidence of treatment-emergent adverse events.