Ublituximab in Relapsing Multiple Sclerosis: Human Study

study phaseThe primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C.

study designThe study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.

subjectsParticipants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.\n* Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.\n* Neurologically stable for \\> 30 days prior to first dose of ublituximab.\n* Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.\n* Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.\n* Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience\n\nExclusion Criteria:\n\n* History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.\n* Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).\n* Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).\n* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).\n* Previous serious opportunistic or atypical infection.\n* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection.

controlledThe study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label."

research categories"briefSummary": "The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C.

relevant ms types"Relapsing Multiple Sclerosis"

intervention"description": "Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24.\n\nWith Protocol Version 6.0, enrollment in Part A was closed.",

comparator"description": "Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24.\n\nWith Protocol Version 7.0, enrollment in Part B will be closed.",

primary endpoint"measure": "Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48",

follow up"timeFrame": "Part A: Baseline, Week 24 and Week 48"

findings"briefSummary": "The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C.

limitationsPlanned enrolment and endpoints are not findings.