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Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02738775
Collaborator
(none)
49
Enrollment
12
Locations
6
Arms
26.5
Actual Duration (Months)
4.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ublituximab
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
A Placebo-Controlled Multi-Center Phase IIa Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.
Actual Study Start Date :
May 27, 2016
Actual Primary Completion Date :
Sep 27, 2017
Actual Study Completion Date :
Aug 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.

Biological: Ublituximab
Administered as an IV infusion.
Other Names:
  • TG-1101

    • Drug: Placebo
    Experimental: Cohort 2

    Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.

    Biological: Ublituximab
    Administered as an IV infusion.
    Other Names:
  • TG-1101

    • Drug: Placebo
    Experimental: Cohort 3

    Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

    Biological: Ublituximab
    Administered as an IV infusion.
    Other Names:
  • TG-1101

    • Drug: Placebo
    Experimental: Cohort 4

    Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

    Biological: Ublituximab
    Administered as an IV infusion.
    Other Names:
  • TG-1101

    • Drug: Placebo
    Experimental: Cohort 5

    Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

    Biological: Ublituximab
    Administered as an IV infusion.
    Other Names:
  • TG-1101

    • Drug: Placebo
    Experimental: Cohort 6

    Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.

    Biological: Ublituximab
    Administered as an IV infusion.
    Other Names:
  • TG-1101

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Responder Rate of B-Cell Depletion at Week 4 [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).

    Secondary Outcome Measures

    1. Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 [Weeks 24 and 48]

      The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.

    2. Number of New or Enlarging T2 Lesions at Weeks 24 and 48 [Weeks 24 and 48]

      The new or enlarging T2 lesions were evaluated using MRI technique.

    3. Annualized Relapse Rate (ARR) [Week 48]

      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).

    4. Relapse Rate Reduction (RRR) [Baseline to Week 48]

      RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.

    5. Percentage of Relapse Free Participants [Week 48]

      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.

    6. Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells [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]

      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.

    7. Change From Baseline in Sustained B Cell [Baseline to pre-dose at Week 24 and Week 48]

      Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48.

    8. Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) [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]

      A blood sample was collected and was sent to the laboratory for analysis of CD4+.

    9. Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) [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]

      A blood sample was collected and was sent to the laboratory for analysis of CD8+.

    10. Additional Immune Profiling-Interleukin 10 (IL10) [Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48]

      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.

    11. Additional Immune Profiling-Natural Killer (NK) Cells [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]

      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.

    12. Pharmacokinetic Parameter: Plasma Concentration of Ublituximab [Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25]

      Plasma concentration is defined as the measured concentration of ublituximab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of relapsing multiple sclerosis

    • Active disease

    • Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

    Exclusion Criteria:

    • Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months

    • Treatment with alemtuzumab within the last 12 months

    • Pregnant or nursing mothers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Phoenix Arizona United States 85018
    2 TG Therapeutics Investigational Trial Site Pasadena California United States 91105
    3 TG Therapeutics Investigational Trial Site Torrance California United States 90502
    4 TG Therapeutics Investigational Trial Site Aurora Colorado United States 80045
    5 TG Therapeutics Investigational Trial Site Fort Collins Colorado United States 80528
    6 TG Therapeutics Investigational Trial Site Lexington Kentucky United States 40509
    7 TG Therapeutics Investigational Trial Site Teaneck New Jersey United States 07666
    8 TG Therapeutics Investigational Trial Site Akron Ohio United States 44320
    9 TG Therapeutics Investigational Trial Site Columbus Ohio United States 43201
    10 TG Therapeutics Investigational Trial Site Knoxville Tennessee United States 37922
    11 TG Therapeutics Investigational Trial Site Round Rock Texas United States 78681
    12 TG Therapeutics Investigational Trial Site San Antonio Texas United States 78258

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    • Study Chair: Edward Fox, MD, PhD, Central Texas Neurology

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02738775
    Other Study ID Numbers:
    • TG1101-RMS-201
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by TG Therapeutics, Inc.
    multiple sclerosis
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 49 participants were randomized in this study. One participant was treated with placebo only; 12 participants were treated with placebo prior to treatment with ublituximab.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Period Title: Overall Study
    STARTED 8 8 8 9 8 8
    Initially Treated With Placebo 0 0 0 1 0 0
    COMPLETED 8 6 8 8 8 7
    NOT COMPLETED 0 2 0 1 0 1

    Baseline Characteristics

    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Total
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Total of all reporting groups
    Overall Participants 8 8 8 8 8 8 48
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.4
    (12.09)
    34.3
    (9.13)
    44.9
    (9.06)
    35.1
    (9.22)
    43.5
    (6.39)
    36.5
    (8.33)
    39.4
    (9.70)
    Sex: Female, Male (Count of Participants)
    Female
    5
    62.5%
    6
    75%
    5
    62.5%
    5
    62.5%
    8
    100%
    3
    37.5%
    32
    66.7%
    Male
    3
    37.5%
    2
    25%
    3
    37.5%
    3
    37.5%
    0
    0%
    5
    62.5%
    16
    33.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    2
    25%
    1
    12.5%
    2
    25%
    1
    12.5%
    3
    37.5%
    9
    18.8%
    Not Hispanic or Latino
    8
    100%
    6
    75%
    7
    87.5%
    6
    75%
    7
    87.5%
    5
    62.5%
    39
    81.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Black or African American
    2
    25%
    0
    0%
    2
    25%
    2
    25%
    0
    0%
    1
    12.5%
    7
    14.6%
    White
    6
    75%
    7
    87.5%
    6
    75%
    6
    75%
    8
    100%
    6
    75%
    39
    81.3%
    Other
    0
    0%
    1
    12.5%
    0
    0%
    0
    0%
    0
    0%
    1
    12.5%
    2
    4.2%

    Outcome Measures

    1. Primary Outcome
    Title Responder Rate of B-Cell Depletion at Week 4
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Number (95% Confidence Interval) [percentage of participants]
    87.5
    1093.8%
    100.0
    1250%
    87.5
    1093.8%
    100.0
    1250%
    100.0
    1250%
    100.0
    1250%
    2. Secondary Outcome
    Title Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
    Description The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.
    Time Frame Weeks 24 and 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 7 8 8 8 7
    Week 24
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    Week 48
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    0.0
    (0.00)
    3. Secondary Outcome
    Title Number of New or Enlarging T2 Lesions at Weeks 24 and 48
    Description The new or enlarging T2 lesions were evaluated using MRI technique.
    Time Frame Weeks 24 and 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg / 1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 7 8 8 8 7
    Week 24
    0.38
    (0.52)
    0.29
    (0.49)
    0.00
    (0.00)
    0.25
    (0.71)
    0.00
    (0.00)
    0.14
    (0.38)
    Week 48
    0.25
    (0.71)
    0.00
    (0.00)
    0.00
    (0.00)
    0.00
    (0.00)
    0.00
    (0.00)
    0.00
    (0.00)
    4. Secondary Outcome
    Title Annualized Relapse Rate (ARR)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Number [relapses per participant-years]
    0.28
    0.00
    0.14
    0.14
    0.00
    0.00
    5. Secondary Outcome
    Title Relapse Rate Reduction (RRR)
    Description RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
    Time Frame Baseline to Week 48

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Number [percentage reduction]
    75.55
    100.00
    87.80
    89.04
    100.00
    100.00
    6. Secondary Outcome
    Title Percentage of Relapse Free Participants
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Number (95% Confidence Interval) [percentage of participants]
    75.0
    937.5%
    100.0
    1250%
    87.5
    1093.8%
    87.5
    1093.8%
    100.0
    1250%
    100.0
    1250%
    7. Secondary Outcome
    Title Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    B Cells (CD19+): Baseline
    7.40
    (4.108)
    7.89
    (3.899)
    7.24
    (4.586)
    8.11
    (2.696)
    5.71
    (2.368)
    6.78
    (2.097)
    B Cells (CD19+): Change from Baseline to Week 1 Day 2
    -6.55
    (3.920)
    -8.29
    (3.850)
    -6.54
    (4.715)
    -7.95
    (2.719)
    -5.66
    (2.347)
    -6.70
    (2.123)
    B Cells (CD19+): Change from Baseline to Week 2
    -7.52
    (3.175)
    -7.80
    (3.878)
    -7.13
    (4.617)
    -6.95
    (1.806)
    -5.68
    (2.362)
    -6.73
    (2.090)
    B Cells (CD19+): Change from Baseline to Week 3 Day 15
    -7.27
    (4.053)
    -7.80
    (3.830)
    -7.17
    (4.592)
    -8.03
    (2.714)
    -5.69
    (2.369)
    -6.72
    (2.080)
    B Cells (CD19+): Change from Baseline to Week 4
    -7.28
    (4.127)
    -7.79
    (3.859)
    -6.82
    (4.889)
    -8.03
    (2.717)
    -6.03
    (2.322)
    -6.71
    (2.102)
    B Cells (CD19+): Change from Baseline to Week 8
    -7.29
    (4.102)
    -7.79
    (3.886)
    -7.15
    (4.625)
    -8.03
    (3.032)
    -5.69
    (2.358)
    -6.70
    (2.065)
    B Cells (CD19+): Change from Baseline to Week 12
    -7.47
    (4.592)
    -7.77
    (3.823)
    -7.17
    (4.617)
    -8.45
    (2.644)
    -5.35
    (2.317)
    -7.14
    (1.820)
    B Cells (CD19+): Change from Baseline to Week 16
    -7.01
    (4.352)
    -7.53
    (4.110)
    -7.75
    (4.628)
    -7.83
    (2.667)
    -5.68
    (2.375)
    -6.89
    (2.178)
    B Cells (CD19+): Change from Baseline to Week 20
    -7.23
    (4.116)
    -8.07
    (4.449)
    -7.18
    (4.637)
    -7.58
    (2.740)
    -5.70
    (2.534)
    -6.65
    (2.200)
    B Cells (CD19+): Change from Baseline to Week 24
    -7.21
    (4.068)
    -7.53
    (3.399)
    -7.76
    (4.478)
    -7.39
    (2.940)
    -5.65
    (2.377)
    -5.62
    (1.992)
    B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days
    -7.31
    (4.108)
    -6.45
    (2.919)
    -7.98
    (4.430)
    -7.88
    (2.895)
    -6.29
    (2.403)
    -7.47
    (1.983)
    B Cells (CD19+): Change from Baseline to Week 25
    -6.45
    (3.698)
    -8.20
    (4.007)
    -7.88
    (4.512)
    -8.06
    (2.694)
    -5.57
    (2.544)
    -7.47
    (2.008)
    B Cells (CD19+): Change from Baseline to Week 28
    -7.31
    (4.106)
    -6.81
    (2.844)
    -7.18
    (4.597)
    -8.00
    (2.699)
    -5.65
    (2.360)
    -6.64
    (2.258)
    B Cells (CD19+): Change from Baseline to Week 36
    -7.32
    (4.082)
    -6.79
    (2.820)
    -7.18
    (4.601)
    -8.48
    (2.905)
    -5.69
    (2.530)
    -6.64
    (2.255)
    B Cells (CD19+): Change from Baseline to Week 40
    -5.40
    (3.828)
    -6.74
    (2.838)
    -7.15
    (4.567)
    -7.77
    (3.132)
    -5.65
    (2.343)
    -6.56
    (2.299)
    B Cells (CD19+): Change from Baseline to Week 44
    -7.32
    (4.092)
    -6.74
    (2.801)
    -7.05
    (4.546)
    -8.06
    (2.860)
    -5.65
    (2.341)
    -6.59
    (2.296)
    B Cells (CD19+): Change from Baseline to Week 48
    -7.25
    (4.086)
    -6.71
    (2.854)
    -6.87
    (4.542)
    -7.73
    (2.621)
    -5.67
    (2.342)
    -7.39
    (2.174)
    Memory (CD19+CD27+): Baseline
    0.38
    (0.337)
    0.92
    (0.722)
    0.90
    (1.010)
    0.68
    (0.457)
    0.88
    (0.997)
    0.60
    (0.367)
    Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2
    -0.28
    (0.279)
    -0.92
    (0.728)
    -0.90
    (1.098)
    -0.59
    (0.480)
    -0.85
    (1.001)
    -0.54
    (0.357)
    Memory (CD19+CD27+): Change from Baseline to Week 2
    -0.32
    (0.354)
    -0.86
    (0.713)
    -0.83
    (1.032)
    -0.46
    (0.411)
    -0.86
    (1.003)
    -0.57
    (0.357)
    Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15
    -0.31
    (0.285)
    -0.86
    (0.694)
    -0.86
    (1.007)
    -0.63
    (0.468)
    -0.87
    (1.001)
    -0.57
    (0.382)
    Memory (CD19+CD27+): Change from Baseline to Week 4
    -0.31
    (0.347)
    -0.85
    (0.690)
    -0.64
    (0.910)
    -0.64
    (0.465)
    -0.91
    (1.072)
    -0.55
    (0.396)
    Memory (CD19+CD27+): Change from Baseline to Week 8
    -0.32
    (0.331)
    -0.86
    (0.736)
    -0.85
    (1.030)
    -0.64
    (0.552)
    -0.87
    (0.994)
    -0.55
    (0.381)
    Memory (CD19+CD27+): Change from Baseline to Week 12
    -0.36
    (0.364)
    -0.83
    (0.668)
    -0.87
    (1.019)
    -0.69
    (0.494)
    -0.92
    (1.068)
    -0.60
    (0.381)
    Memory (CD19+CD27+): Change from Baseline to Week 16
    -0.30
    (0.355)
    -0.92
    (0.769)
    -0.93
    (1.068)
    -0.65
    (0.456)
    -0.87
    (1.004)
    -0.56
    (0.427)
    Memory (CD19+CD27+): Change from Baseline to Week 20
    -0.27
    (0.335)
    -0.86
    (0.849)
    -1.07
    (1.101)
    -0.64
    (0.431)
    -0.88
    (1.064)
    -0.52
    (0.421)
    Memory (CD19+CD27+): Change from Baseline to Week 24
    -0.30
    (0.340)
    -0.84
    (0.656)
    -0.96
    (1.038)
    -0.69
    (0.442)
    -0.86
    (1.007)
    -0.59
    (0.444)
    Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days
    -0.34
    (0.330)
    -0.74
    (0.434)
    -0.76
    (0.875)
    -0.59
    (0.469)
    -0.91
    (1.168)
    -0.65
    (0.469)
    Memory (CD19+CD27+): Change from Baseline to Week 25
    -0.28
    (0.371)
    -0.97
    (0.738)
    -0.98
    (1.057)
    -0.65
    (0.465)
    -0.95
    (1.033)
    -0.61
    (0.404)
    Memory (CD19+CD27+): Change from Baseline to Week 28
    -0.34
    (0.336)
    -0.68
    (0.442)
    -0.87
    (1.021)
    -0.62
    (0.508)
    -0.85
    (0.971)
    -0.60
    (0.368)
    Memory (CD19+CD27+): Change from Baseline to Week 36
    -0.34
    (0.322)
    -0.68
    (0.436)
    -0.87
    (1.020)
    -0.75
    (0.495)
    -0.88
    (1.069)
    -0.59
    (0.400)
    Memory (CD19+CD27+): Change from Baseline to Week 40
    -0.20
    (0.086)
    -0.68
    (0.441)
    -0.86
    (1.012)
    -0.62
    (0.450)
    -0.85
    (0.975)
    -0.57
    (0.424)
    Memory (CD19+CD27+): Change from Baseline to Week 44
    -0.34
    (0.341)
    -0.66
    (0.429)
    -0.85
    (0.997)
    -0.69
    (0.462)
    -0.85
    (1.008)
    -0.62
    (0.444)
    Memory (CD19+CD27+): Change from Baseline to Week 48
    -0.32
    (0.344)
    -0.65
    (0.463)
    -0.83
    (0.983)
    -0.62
    (0.433)
    -0.86
    (1.007)
    -0.71
    (0.414)
    Naïve (CD19+CD27-): Baseline
    6.92
    (3.837)
    7.30
    (3.188)
    6.26
    (4.043)
    7.00
    (2.135)
    4.73
    (2.206)
    6.11
    (2.096)
    Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2
    -6.18
    (3.665)
    -7.29
    (3.427)
    -5.56
    (3.954)
    -6.93
    (2.132)
    -4.72
    (2.203)
    -6.09
    (2.100)
    Naïve (CD19+CD27-): Change from Baseline to Week 2
    -7.09
    (2.899)
    -7.27
    (3.177)
    -6.23
    (4.058)
    -6.18
    (1.723)
    -4.73
    (2.205)
    -6.10
    (2.089)
    Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15
    -6.86
    (3.805)
    -7.27
    (3.161)
    -6.23
    (4.043)
    -6.97
    (2.137)
    -4.73
    (2.205)
    -6.09
    (2.081)
    Naïve (CD19+CD27-): Change from Baseline to Week 4
    -6.87
    (3.836)
    -7.26
    (3.173)
    -6.13
    (4.342)
    -6.96
    (2.134)
    -5.02
    (2.211)
    -6.09
    (2.092)
    Naïve (CD19+CD27-): Change from Baseline to Week 8
    -6.88
    (3.831)
    -7.26
    (3.173)
    -6.22
    (4.057)
    -6.99
    (2.322)
    -4.73
    (2.203)
    -6.08
    (2.093)
    Naïve (CD19+CD27-): Change from Baseline to Week 12
    -7.00
    (4.287)
    -7.26
    (3.175)
    -6.23
    (4.061)
    -7.29
    (2.060)
    -4.36
    (2.100)
    -6.47
    (1.907)
    Naïve (CD19+CD27-): Change from Baseline to Week 16
    -6.61
    (4.067)
    -7.00
    (3.341)
    -6.74
    (4.085)
    -6.76
    (2.098)
    -4.73
    (2.209)
    -6.27
    (2.184)
    Naïve (CD19+CD27-): Change from Baseline to Week 20
    -6.87
    (3.828)
    -7.67
    (3.234)
    -6.02
    (3.994)
    -6.52
    (2.214)
    -4.73
    (2.377)
    -6.06
    (2.139)
    Naïve (CD19+CD27-): Change from Baseline to Week 24
    -6.81
    (3.788)
    -7.02
    (2.809)
    -6.71
    (4.024)
    -6.26
    (2.275)
    -4.71
    (2.207)
    -4.96
    (1.658)
    Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days
    -6.87
    (3.842)
    -6.18
    (2.666)
    -7.15
    (4.231)
    -6.81
    (2.272)
    -5.28
    (2.286)
    -6.74
    (2.156)
    Naïve (CD19+CD27-): Change from Baseline to Week 25
    -6.13
    (3.473)
    -7.61
    (3.257)
    -6.81
    (4.012)
    -6.98
    (2.132)
    -4.52
    (2.305)
    -6.74
    (2.148)
    Naïve (CD19+CD27-): Change from Baseline to Week 28
    -6.87
    (3.837)
    -6.53
    (2.612)
    -6.24
    (4.047)
    -6.95
    (2.139)
    -4.71
    (2.208)
    -5.97
    (2.235)
    Naïve (CD19+CD27-): Change from Baseline to Week 36
    -6.89
    (3.830)
    -6.52
    (2.594)
    -6.23
    (4.051)
    -7.22
    (2.249)
    -4.72
    (2.374)
    -5.97
    (2.233)
    Naïve (CD19+CD27-): Change from Baseline to Week 40
    -5.18
    (3.740)
    -6.46
    (2.565)
    -6.21
    (4.042)
    -6.63
    (2.419)
    -4.72
    (2.204)
    -5.92
    (2.266)
    Naïve (CD19+CD27-): Change from Baseline to Week 44
    -6.89
    (3.831)
    -6.48
    (2.573)
    -6.13
    (4.050)
    -6.98
    (2.283)
    -4.72
    (2.204)
    -5.94
    (2.248)
    Naïve (CD19+CD27-): Change from Baseline to Week 48
    -6.83
    (3.809)
    -6.46
    (2.580)
    -5.96
    (4.091)
    -6.69
    (2.060)
    -4.73
    (2.205)
    -6.60
    (2.292)
    8. Secondary Outcome
    Title Change From Baseline in Sustained B Cell
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Baseline
    7.40
    (4.108)
    7.89
    (3.899)
    7.24
    (4.586)
    8.11
    (2.696)
    5.71
    (2.368)
    6.78
    (2.097)
    Change at Pre-dose at Week 24
    -7.21
    (4.068)
    -7.53
    (3.399)
    -7.76
    (4.478)
    -7.39
    (2.940)
    -5.65
    (2.377)
    -5.62
    (1.992)
    Change at Pre-dose at Week 48
    -7.25
    (4.086)
    -6.71
    (2.854)
    -6.87
    (4.542)
    -7.73
    (2.621)
    -5.67
    (2.342)
    -7.39
    (2.174)
    9. Secondary Outcome
    Title Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Baseline
    28.73
    (12.195)
    35.39
    (4.628)
    24.34
    (12.877)
    25.75
    (6.874)
    22.70
    (9.488)
    22.27
    (10.588)
    Week 1 Day 2
    22.71
    (15.829)
    27.52
    (11.388)
    19.51
    (9.129)
    16.98
    (11.624)
    16.49
    (13.985)
    14.15
    (5.911)
    Week 2
    34.01
    (7.190)
    39.83
    (8.829)
    33.31
    (4.862)
    36.51
    (9.289)
    28.50
    (8.173)
    25.69
    (8.761)
    Week 3 Day 15
    23.74
    (11.399)
    26.51
    (10.650)
    22.60
    (7.766)
    27.68
    (13.656)
    19.88
    (13.902)
    24.57
    (11.080)
    Week 4
    26.19
    (11.922)
    35.31
    (11.530)
    31.47
    (8.658)
    30.97
    (12.840)
    24.62
    (8.087)
    27.59
    (11.016)
    Week 8
    29.74
    (15.735)
    31.46
    (8.387)
    29.64
    (8.204)
    30.95
    (14.625)
    27.73
    (9.162)
    24.59
    (4.511)
    Week 12
    24.20
    (8.152)
    32.26
    (7.118)
    30.98
    (11.476)
    27.71
    (9.209)
    28.03
    (12.045)
    24.09
    (8.087)
    Week 16
    24.03
    (10.040)
    31.55
    (7.557)
    19.19
    (10.466)
    31.27
    (12.131)
    27.37
    (14.733)
    17.85
    (4.155)
    Week 20
    22.94
    (9.492)
    26.87
    (11.629)
    34.25
    (8.928)
    33.56
    (8.537)
    27.17
    (7.908)
    24.51
    (13.149)
    Week 24
    29.24
    (8.678)
    29.36
    (8.856)
    31.33
    (13.406)
    29.12
    (7.006)
    26.71
    (9.603)
    17.41
    (7.523)
    Week 24 Plus 2 Days
    26.25
    (8.120)
    27.54
    (5.269)
    22.82
    (17.385)
    36.47
    (12.548)
    23.59
    (6.912)
    21.22
    (8.474)
    Week 25
    30.70
    (8.594)
    27.31
    (13.091)
    35.42
    (8.854)
    28.46
    (9.801)
    27.96
    (6.024)
    17.57
    (10.438)
    Week 28
    20.03
    (11.870)
    31.70
    (13.654)
    29.71
    (13.051)
    23.57
    (10.565)
    23.09
    (8.855)
    21.64
    (14.610)
    Week 36
    26.79
    (14.209)
    28.06
    (9.436)
    37.56
    (8.664)
    22.86
    (8.413)
    14.73
    (5.916)
    28.20
    (15.386)
    Week 40
    25.31
    (10.664)
    30.91
    (10.601)
    28.45
    (11.497)
    28.10
    (9.464)
    18.17
    (11.192)
    26.68
    (17.744)
    Week 44
    24.77
    (6.469)
    29.84
    (9.013)
    29.83
    (10.774)
    17.17
    (9.920)
    26.22
    (14.340)
    28.24
    (12.190)
    Week 48
    26.72
    (6.914)
    32.92
    (6.697)
    21.90
    (7.779)
    22.60
    (8.935)
    30.85
    (13.016)
    27.03
    (7.844)
    10. Secondary Outcome
    Title Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Baseline
    16.80
    (5.324)
    17.50
    (5.222)
    9.97
    (4.877)
    12.25
    (2.374)
    8.72
    (3.590)
    12.83
    (6.576)
    Week 1 Day 2
    10.04
    (6.698)
    12.06
    (6.524)
    6.87
    (2.746)
    5.93
    (2.748)
    5.14
    (2.779)
    7.61
    (5.157)
    Week 2
    17.03
    (3.654)
    16.96
    (7.869)
    13.22
    (3.141)
    14.68
    (2.377)
    11.14
    (4.767)
    14.22
    (9.157)
    Week 3 Day 15
    12.14
    (6.646)
    11.88
    (6.580)
    9.21
    (4.780)
    12.10
    (6.033)
    7.22
    (4.103)
    12.50
    (6.536)
    Week 4
    13.89
    (5.715)
    14.89
    (7.815)
    11.78
    (3.263)
    13.70
    (5.296)
    9.89
    (2.120)
    13.49
    (5.214)
    Week 8
    15.92
    (8.489)
    13.91
    (5.074)
    10.97
    (3.012)
    12.80
    (7.567)
    9.63
    (3.056)
    12.62
    (5.613)
    Week 12
    15.21
    (8.122)
    17.21
    (6.807)
    11.83
    (5.397)
    11.06
    (3.773)
    8.93
    (4.185)
    14.87
    (9.608)
    Week 16
    16.25
    (6.951)
    13.87
    (7.431)
    6.76
    (3.613)
    12.51
    (3.827)
    10.63
    (6.203)
    10.86
    (5.193)
    Week 20
    15.04
    (7.197)
    10.35
    (5.998)
    10.04
    (3.132)
    13.71
    (3.450)
    10.29
    (5.150)
    12.98
    (7.476)
    Week 24
    15.83
    (4.047)
    13.77
    (5.509)
    11.59
    (5.417)
    12.22
    (5.372)
    12.05
    (6.859)
    9.45
    (6.093)
    Week 24 Plus 2 Days
    14.70
    (3.655)
    13.28
    (6.727)
    7.05
    (4.656)
    15.52
    (5.839)
    8.90
    (1.508)
    9.41
    (3.298)
    Week 25
    15.38
    (6.717)
    12.48
    (4.475)
    12.07
    (4.773)
    11.60
    (4.172)
    9.78
    (2.395)
    8.94
    (6.287)
    Week 28
    11.15
    (4.599)
    12.84
    (5.522)
    10.63
    (6.617)
    11.02
    (3.030)
    9.32
    (2.121)
    9.71
    (3.160)
    Week 36
    12.92
    (7.721)
    11.95
    (5.493)
    12.46
    (2.840)
    10.11
    (4.527)
    6.92
    (3.158)
    11.59
    (2.584)
    Week 40
    14.63
    (3.687)
    12.77
    (7.654)
    9.82
    (3.926)
    11.59
    (4.485)
    7.93
    (2.207)
    10.30
    (4.027)
    Week 44
    14.41
    (6.085)
    11.46
    (2.451)
    9.91
    (3.937)
    8.67
    (5.073)
    9.59
    (3.922)
    11.87
    (3.352)
    Week 48
    13.28
    (6.673)
    12.79
    (5.232)
    7.42
    (2.276)
    9.86
    (5.260)
    11.68
    (5.757)
    13.50
    (3.412)
    11. Secondary Outcome
    Title Additional Immune Profiling-Interleukin 10 (IL10)
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Baseline
    0.25
    (0.175)
    0.37
    (0.343)
    0.41
    (0.459)
    0.40
    (0.247)
    0.13
    (0.129)
    0.09
    (0.120)
    Week 2
    0.39
    (0.258)
    0.39
    (0.350)
    0.27
    (0.184)
    0.42
    (0.070)
    0.16
    (0.143)
    0.07
    (0.120)
    Week 4
    0.53
    (0.294)
    0.42
    (0.290)
    0.40
    (0.286)
    0.34
    (0.135)
    0.62
    (1.059)
    0.25
    (0.358)
    Week 12
    0.57
    (0.599)
    0.89
    (1.223)
    0.70
    (0.783)
    0.26
    (0.422)
    0.04
    (0.028)
    1.19
    (1.147)
    Week 20
    0.24
    (0.160)
    0.65
    (0.631)
    0.24
    (0.141)
    0.13
    (0.213)
    0.57
    (0.467)
    0.64
    (0.593)
    Week 24
    0.43
    (0.454)
    0.45
    (0.363)
    0.49
    (0.635)
    0.29
    (0.325)
    2.14
    (3.329)
    0.91
    (0.778)
    Week 25
    0.32
    (0.163)
    0.40
    (0.237)
    0.18
    (0.292)
    0.24
    (0.237)
    1.31
    (1.168)
    1.36
    (0.922)
    Week 36
    0.21
    (0.124)
    0.36
    (0.543)
    0.08
    (0.068)
    0.79
    (0.769)
    0.95
    (0.535)
    0.82
    (0.303)
    Week 44
    0.15
    (0.164)
    0.35
    (0.715)
    2.77
    (3.101)
    1.25
    (1.268)
    0.65
    (0.452)
    2.11
    (1.533)
    Week 48
    0.07
    (0.063)
    0.44
    (0.551)
    1.87
    (1.465)
    3.13
    (5.552)
    0.68
    (0.773)
    1.23
    (0.568)
    12. Secondary Outcome
    Title Additional Immune Profiling-Natural Killer (NK) Cells
    Description 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

    Outcome Measure Data

    Analysis Population Description
    ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 8 8 8 8 8 8
    Baseline
    6.53
    (2.829)
    7.22
    (4.469)
    5.06
    (2.618)
    7.68
    (3.724)
    5.04
    (2.719)
    4.67
    (1.946)
    Week 1 Day 2
    1.98
    (1.597)
    2.01
    (2.465)
    2.11
    (1.386)
    1.38
    (0.680)
    1.10
    (0.372)
    1.08
    (0.980)
    Week 2
    7.34
    (6.862)
    6.03
    (5.001)
    6.27
    (1.230)
    7.93
    (2.861)
    6.17
    (3.588)
    4.09
    (1.920)
    Week 3 Day 15
    4.99
    (1.647)
    6.62
    (5.840)
    5.63
    (2.792)
    5.93
    (4.679)
    3.50
    (1.717)
    4.40
    (2.570)
    Week 4
    6.45
    (3.189)
    7.88
    (8.131)
    7.49
    (2.242)
    5.72
    (2.458)
    6.12
    (5.440)
    4.80
    (3.352)
    Week 8
    6.22
    (4.761)
    7.53
    (4.347)
    6.79
    (4.172)
    4.80
    (2.463)
    4.81
    (2.573)
    6.21
    (4.520)
    Week 12
    5.47
    (2.114)
    6.33
    (3.053)
    6.71
    (2.328)
    5.25
    (2.494)
    3.46
    (1.469)
    5.71
    (2.446)
    Week 16
    10.49
    (5.747)
    5.28
    (2.548)
    5.91
    (3.136)
    5.34
    (3.057)
    5.58
    (4.578)
    7.34
    (6.747)
    Week 20
    10.17
    (7.791)
    4.46
    (2.638)
    6.81
    (4.994)
    5.73
    (2.105)
    5.79
    (3.144)
    8.03
    (7.391)
    Week 24
    6.70
    (4.883)
    6.51
    (3.781)
    5.84
    (2.890)
    4.55
    (2.243)
    8.51
    (5.484)
    9.81
    (3.968)
    Week 24 Plus 2 Days
    8.31
    (9.513)
    4.45
    (4.072)
    3.75
    (2.422)
    3.38
    (1.684)
    5.83
    (3.711)
    4.97
    (1.110)
    Week 25
    11.45
    (6.599)
    6.56
    (4.849)
    5.91
    (3.133)
    3.71
    (2.199)
    6.51
    (3.541)
    8.34
    (5.602)
    Week 28
    8.06
    (7.674)
    5.47
    (4.326)
    5.69
    (3.218)
    4.73
    (3.334)
    8.29
    (5.664)
    6.95
    (2.970)
    Week 36
    6.63
    (3.648)
    6.36
    (7.256)
    5.72
    (1.275)
    7.88
    (5.515)
    8.22
    (5.772)
    9.58
    (7.535)
    Week 40
    9.17
    (4.527)
    4.67
    (3.109)
    5.20
    (2.904)
    6.18
    (2.901)
    6.64
    (3.070)
    6.90
    (3.244)
    Week 44
    7.20
    (7.764)
    4.40
    (3.481)
    5.00
    (1.733)
    8.97
    (6.008)
    6.59
    (4.777)
    7.14
    (3.195)
    Week 48
    3.84
    (2.081)
    5.23
    (4.943)
    6.72
    (1.960)
    6.94
    (3.601)
    7.05
    (4.446)
    6.10
    (1.930)
    13. Secondary Outcome
    Title Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
    Description 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

    Outcome Measure Data

    Analysis Population Description
    Data for this outcome measure is not reported here because as per pre-specified plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
    Measure Participants 0 0 0 0 0 0

    Adverse Events

    Time Frame From the first dose of study medication through the end of the study (Up to 48 weeks)
    Adverse Event Reporting Description Safety Population included all participants who received at least one dose of ublituximab. Participants who received Placebo in any Cohort are combined for safety analysis.
    Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
    Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of placebo on Day 1 and Day 15.
    All Cause Mortality
    Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Serious Adverse Events
    Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/13 (0%)
    Gastrointestinal disorders
    Diverticulum 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Infections and infestations
    Appendicitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Nervous system disorders
    Seizure 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Social circumstances
    Pregnancy of partner 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/8 (100%) 7/8 (87.5%) 8/8 (100%) 8/8 (100%) 8/8 (100%) 8/8 (100%) 12/13 (92.3%)
    Blood and lymphatic system disorders
    Lymph node pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Cardiac disorders
    Angina pectoris 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Coronary artery disease 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Cyanosis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Ear and labyrinth disorders
    Vertigo 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Ear pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Eustachian tube dysfunction 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Eye disorders
    Vision blurred 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Blepharospasm 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Dacryostenosis acquired 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Eye inflammation 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Eye pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Eyelid oedema 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Visual impairment 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Gastrointestinal disorders
    Nausea 0/8 (0%) 3/8 (37.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 5/8 (62.5%) 2/13 (15.4%)
    Diarrhoea 1/8 (12.5%) 0/8 (0%) 2/8 (25%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Vomiting 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 2/13 (15.4%)
    Constipation 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Dysphagia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 3/8 (37.5%) 0/8 (0%) 2/13 (15.4%)
    Abdominal pain upper 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/13 (15.4%)
    Dyspepsia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Abdominal discomfort 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/13 (7.7%)
    Toothache 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Abdominal pain 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Abdominal pain lower 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Dry mouth 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Food poisoning 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Gastritis 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    General disorders
    Fatigue 0/8 (0%) 3/8 (37.5%) 2/8 (25%) 4/8 (50%) 2/8 (25%) 3/8 (37.5%) 5/13 (38.5%)
    Pyrexia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 2/8 (25%) 1/13 (7.7%)
    Pain 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/13 (7.7%)
    Chills 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Asthenia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Influenza like illness 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Infusion site pain 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Mass 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Temperature intolerance 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Immune system disorders
    Seasonal allergy 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Infections and infestations
    Upper respiratory tract infection 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 3/8 (37.5%) 0/8 (0%) 1/13 (7.7%)
    Influenza 0/8 (0%) 0/8 (0%) 2/8 (25%) 2/8 (25%) 2/8 (25%) 0/8 (0%) 2/13 (15.4%)
    Sinusitis 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 3/8 (37.5%) 0/8 (0%) 0/8 (0%) 2/13 (15.4%)
    Nasopharyngitis 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 3/8 (37.5%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Fungal infection 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Urinary tract infection 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Conjunctivitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Oral herpes 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Vulvovaginal mycotic infection 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Body tinea 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/13 (7.7%)
    Bronchitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Bursitis infective 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Ear infection 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Gastroenteritis viral 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Kidney infection 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Laryngitis 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Localised infection 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Pneumonia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Staphylococcal infection 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Tooth infection 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Injury, poisoning and procedural complications
    Infusion related reaction 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 3/8 (37.5%) 1/8 (12.5%) 3/13 (23.1%)
    Contusion 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Fall 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Skin laceration 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Skin abrasion 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Wrist fracture 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Investigations
    White blood cell count decreased 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Blood creatinine increased 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Heart rate abnormal 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Heart rate increased 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Influenza B virus test positive 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Hypercholesterolaemia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Vitamin B12 deficiency 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Vitamin D deficiency 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/8 (12.5%) 2/8 (25%) 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 1/13 (7.7%)
    Back pain 3/8 (37.5%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Muscle spasms 0/8 (0%) 2/8 (25%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Musculoskeletal pain 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Muscle tightness 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Neck pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Pain in extremity 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Musculoskeletal stiffness 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Joint swelling 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Muscle twitching 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Muscular weakness 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Musculoskeletal chest pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Papilloma 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Nervous system disorders
    Headache 2/8 (25%) 3/8 (37.5%) 1/8 (12.5%) 2/8 (25%) 2/8 (25%) 2/8 (25%) 2/13 (15.4%)
    Hypoaesthesia 2/8 (25%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 3/8 (37.5%) 1/13 (7.7%)
    Dizziness 0/8 (0%) 3/8 (37.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 3/8 (37.5%) 3/13 (23.1%)
    Migraine 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Memory impairment 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Carpal tunnel syndrome 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Neuropathy peripheral 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Tremor 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Sensory loss 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/13 (7.7%)
    Uhthoffs phenomenon 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Amnesia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Burning sensation 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Cognitive disorder 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Facial paralysis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Lethargy 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Multiple sclerosis relapse 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Muscle spasticity 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Myelitis transverse 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Neuralgia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Nystagmus 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Occipital neuralgia 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Paraesthesia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/13 (7.7%)
    Sensory disturbance 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Vibratory sense increased 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Psychiatric disorders
    Depression 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Insomnia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Mood swings 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Somnambulism 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Stress 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Renal and urinary disorders
    Bladder pain 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Dysuria 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Hypertonic bladder 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Reproductive system and breast disorders
    Menorrhagia 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Adenomyosis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Vaginal odour 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Respiratory, thoracic and mediastinal disorders
    Throat irritation 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 3/8 (37.5%) 0/8 (0%) 2/13 (15.4%)
    Cough 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 2/8 (25%) 1/13 (7.7%)
    Oropharyngeal pain 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Dyspnoea 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/13 (15.4%)
    Rhinorrhoea 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 1/13 (7.7%)
    Asthma 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Dry throat 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Pulmonary congestion 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Sinus congestion 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Upper respiratory tract congestion 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Skin and subcutaneous tissue disorders
    Rash 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 2/8 (25%) 0/8 (0%) 1/13 (7.7%)
    Pruritus 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Nail discolouration 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Dermatitis contact 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/13 (0%)
    Dry skin 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)
    Ecchymosis 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Eczema 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Psoriasis 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Rosacea 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Skin lesion 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/13 (7.7%)
    Vascular disorders
    Flushing 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 1/13 (7.7%)
    Haematoma 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/13 (7.7%)
    Hot flush 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/13 (0%)
    Hypertension 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/13 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title TG Therapeutics Clinical Support Team
    Organization TG Therapeutics
    Phone 1-877-575-8489
    Email clinicalsupport@tgtxinc.com
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02738775
    Other Study ID Numbers:
    • TG1101-RMS-201
    First Posted:
    Apr 14, 2016
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jun 1, 2021