Ublituximab in Pediatric Participants with Relapsing forms of Multiple Sclerosis (RMS)

Condition studied

Relapsing Multiple Sclerosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

(Part C) Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal Ideation Columbia-Suicide Severity Rating Scale (C-SSRS), (Part A) Percentage of patients with CD19+ B cell at a defined level

Endpoint detail

Part A: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part A: Pharmacology a. Serum concentrations of ublituximab b. Percentage of participants with anti-drug antibodies (ADAs) to ublituximab, Part B: Safety a. Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0 b. Suicidal ideation Columbia-Suicide Severity Rating Scale (C-SSRS), Part B: Pharmacology a. Calculated PK parameters of ublituximab b. CD19+ B cell counts c. Percentage of participants with Treatment Emergent Anti-Drug Antibody(TE-ADAs) to ublituximab