This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Administered as an IV infusion.
TG Therapeutics Investigational Trial Site
Phoenix, Arizona, United States
TG Therapeutics Investigational Trial Site
Pasadena, California, United States
TG Therapeutics Investigational Trial Site
Torrance, California, United States
Responder Rate of B-Cell Depletion at Week 4
Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive \[CD19+\] cells) within 2 weeks after the second infusion (Day 15).
Time frame: Week 4
Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.
Time frame: Weeks 24 and 48
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
The new or enlarging T2 lesions were evaluated using MRI technique.
Time frame: Weeks 24 and 48
Annualized Relapse Rate (ARR)
ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years).
Time frame: Week 48
Relapse Rate Reduction (RRR)
RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
Time frame: Baseline to Week 48
Percentage of Relapse Free Participants
Participant was considered as free of clinical relapse if participant had no confirmed clinical relapse before treatment discontinuation/until end of Week 48. Relapses are defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS), and immediately preceded by a stable or improving neurological state of at least 30 days.
Time frame: Week 48
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TG Therapeutics Investigational Trial Site
Aurora, Colorado, United States
TG Therapeutics Investigational Trial Site
Fort Collins, Colorado, United States
TG Therapeutics Investigational Trial Site
Lexington, Kentucky, United States
TG Therapeutics Investigational Trial Site
Teaneck, New Jersey, United States
TG Therapeutics Investigational Trial Site
Akron, Ohio, United States
TG Therapeutics Investigational Trial Site
Columbus, Ohio, United States
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, United States
...and 2 more locations
Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
Cluster of Differentiation (CD)19 is a marker of B cells, the protein has been used to diagnose cancers that arise from this type of cell - notably B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The majority of B cell malignancies express normal to high levels of CD19. Memory B cell is a type of B lymphocyte that forms part of the adaptive immune system. These cells develop within germinal centers of the secondary lymphoid organs. Their function is to memorize the characteristics of the antigen that activated their parent B cell during initial infection such that if the memory B cell later encounters the same antigen, it triggers an accelerated and robust secondary immune response. A naive B cell is a B cell that has not been exposed to an antigen. Once exposed to an antigen, the naive B cell either becomes a memory B cell or a plasma cell that secretes antibodies specific to the antigen that was originally bound.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48
Change From Baseline in Sustained B Cell
Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48.
Time frame: Baseline to pre-dose at Week 24 and Week 48
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD4+.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD8+.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Additional Immune Profiling-Interleukin 10 (IL10)
A blood sample was collected and was sent to the laboratory for analysis of IL-10. IL-10 is an anti-inflammatory cytokine that maintains the balance of the immune response, allowing the clearance of infection while minimizing damage to the host.
Time frame: Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48
Additional Immune Profiling-Natural Killer (NK) Cells
A blood sample was collected and was sent to the laboratory for analysis of NK cells. Percentage of NK cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Time frame: Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
Plasma concentration is defined as the measured concentration of ublituximab.
Time frame: Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25