Phase IIa Study of Ublituximab in Participants With Relap... | NCT02738775 | Trialant
NCT02738775
Sponsor
TG Therapeutics, Inc.
Status
Completed
Last Update Posted
Jul 15, 2021Actual
Enrollment
49Actual
Phase
Phase 2
Conditions
Multiple Sclerosis
Interventions
Ublituximab
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02738775
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TG1101-RMS-201
Secondary IDs
Not provided
Brief Title
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
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.
Acronym
Not provided
Organization
TG Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 27, 2016Actual
Primary Completion Date
Sep 27, 2017Actual
Completion Date
Aug 13, 2018Actual
First Submitted Date
Apr 10, 2016
First Submission Date that Met QC Criteria
Apr 11, 2016
First Posted Date
Apr 14, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 22, 2021
Results First Submitted that Met QC Criteria
Jun 22, 2021
Results First Posted Date
Jul 15, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 22, 2021
Last Update Posted Date
Jul 15, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TG Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Sclerosis
Keywords
multiple sclerosis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
49Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
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
Drug: Placebo
Cohort 2
Experimental
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
Drug: Placebo
Cohort 3
Experimental
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
Drug: Placebo
Cohort 4
Experimental
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
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ublituximab
Biological
Administered as an IV infusion.
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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).
Week 4
Secondary Outcomes
Measure
Description
Time Frame
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.
Weeks 24 and 48
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Edward Fox, MD, PhD
Central Texas Neurology
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
TG Therapeutics Investigational Trial Site
Phoenix
Arizona
85018
United States
TG Therapeutics Investigational Trial Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Data will be shared after study completion via publication
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 10, 2017
Jun 22, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantCare Provider
Cohort 5
Experimental
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
Drug: Placebo
Cohort 6
Experimental
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
Drug: Placebo
Cohort 6
TG-1101
Placebo
Drug
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
The new or enlarging T2 lesions were evaluated using MRI technique.
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).
Week 48
Relapse Rate Reduction (RRR)
RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
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.
Week 48
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.
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.
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+.
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+.
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.
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.
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.
Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25
Pasadena
California
91105
United States
TG Therapeutics Investigational Trial Site
Torrance
California
90502
United States
TG Therapeutics Investigational Trial Site
Aurora
Colorado
80045
United States
TG Therapeutics Investigational Trial Site
Fort Collins
Colorado
80528
United States
TG Therapeutics Investigational Trial Site
Lexington
Kentucky
40509
United States
TG Therapeutics Investigational Trial Site
Teaneck
New Jersey
07666
United States
TG Therapeutics Investigational Trial Site
Akron
Ohio
44320
United States
TG Therapeutics Investigational Trial Site
Columbus
Ohio
43201
United States
TG Therapeutics Investigational Trial Site
Knoxville
Tennessee
37922
United States
TG Therapeutics Investigational Trial Site
Round Rock
Texas
78681
United States
TG Therapeutics Investigational Trial Site
San Antonio
Texas
78258
United States
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0039 subjects
FG0048 subjects
FG0058 subjects
Initially Treated With Placebo
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0057 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Missing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Intent-to-Treat (ITT) population included all participants who received at least one dose of ublituximab.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0018
BG0028
BG0038
BG0048
BG0058
BG00648
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.4± 12.09
BG00134.3± 9.13
BG00244.9± 9.06
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Black or African American
BG0002
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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).
ITT population included all participants who received at least one dose of ublituximab.
Posted
Number
95% Confidence Interval
percentage of participants
Week 4
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00087.5(47.35 to 99.68)
OG001100.0(63.06 to 100)
OG00287.5(47.35 to 99.68)
OG003
Secondary
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.
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.
Posted
Mean
Standard Deviation
lesions
Weeks 24 and 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
The new or enlarging T2 lesions were evaluated using MRI technique.
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.
Posted
Mean
Standard Deviation
lesions
Weeks 24 and 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
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).
ITT population included all participants who received at least one dose of ublituximab.
Posted
Number
relapses per participant-years
Week 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
Relapse Rate Reduction (RRR)
RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
ITT population included all participants who received at least one dose of ublituximab.
Posted
Number
percentage reduction
Baseline to Week 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
OG003
Secondary
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.
ITT population included all participants who received at least one dose of ublituximab.
Posted
Number
95% Confidence Interval
percentage of participants
Week 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
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.
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.
Posted
Mean
Standard Deviation
percentage of 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
ID
Title
Description
OG000
Cohort 1
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.
Secondary
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.
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.
Posted
Mean
Standard Deviation
percentage of cells
Baseline to pre-dose at Week 24 and Week 48
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD4+.
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.
Posted
Mean
Standard Deviation
cells per cubic millimeter (cells/mm^3)
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
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
A blood sample was collected and was sent to the laboratory for analysis of CD8+.
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.
Posted
Mean
Standard Deviation
cells/mm^3
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
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Secondary
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.
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.
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.
OG001
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.
OG002
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.
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.
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.
Posted
Mean
Standard Deviation
percentage of cells/mL
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
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
Cohort 3
Secondary
Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
Plasma concentration is defined as the measured concentration of ublituximab.
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.
Posted
Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25
ID
Title
Description
OG000
Cohort 1
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.
OG001
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.
OG002
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.
Time Frame
From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1
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.
0
8
0
8
8
8
EG001
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.
0
8
1
8
7
8
EG002
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.
0
8
2
8
8
8
EG003
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.
0
8
0
8
8
8
EG004
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.
0
8
0
8
8
8
EG005
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.
0
8
2
8
8
8
EG006
Placebo
Participant received IV infusion of placebo on Day 1 and Day 15.
0
13
0
13
12
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected13 at risk
Diverticulum
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Pregnancy of partner
Social circumstances
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected8 at risk
EG0013 affected8 at risk
EG0021 affected8 at risk
EG0032 affected8 at risk
EG0042 affected8 at risk
EG0052 affected8 at risk
EG0062 affected13 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected8 at risk
EG0020 affected8 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Sensory loss
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Uhthoffs phenomenon
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Myelitis transverse
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Occipital neuralgia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Vibratory sense increased
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0021 affected8 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Body tinea
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected8 at risk
EG0021 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0013 affected8 at risk
EG0022 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Infusion site pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Mass
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Temperature intolerance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0012 affected8 at risk
EG0022 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0012 affected8 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0022 affected8 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0002 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Somnambulism
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Stress
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Flushing
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Heart rate abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Heart rate increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Influenza B virus test positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Vaginal odour
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0021 affected8 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0038
OG0048
OG0057
Title
Denominators
Categories
Week 24
Title
Measurements
OG0000.0± 0.00
OG0010.0± 0.00
OG0020.0± 0.00
OG0030.0± 0.00
OG0040.0± 0.00
OG0050.0± 0.00
Week 48
Title
Measurements
OG0000.0± 0.00
OG0010.0± 0.00
OG0020.0± 0.00
OG003
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG0038
OG0048
OG0057
Title
Denominators
Categories
Week 24
Title
Measurements
OG0000.38± 0.52
OG0010.29± 0.49
OG0020.00± 0.00
OG0030.25± 0.71
OG0040.00± 0.00
OG0050.14± 0.38
Week 48
Title
Measurements
OG0000.25± 0.71
OG0010.00± 0.00
OG0020.00± 0.00
OG003
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Title
Measurements
OG0000.28
OG0010.00
OG0020.14
OG0030.14
OG0040.00
OG0050.00
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Title
Measurements
OG00075.55
OG001100.00
OG00287.80
OG00389.04
OG004100.00
OG005100.00
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Title
Measurements
OG00075.0(34.91 to 96.81)
OG001100.0(63.06 to 100)
OG00287.5(47.35 to 99.68)
OG00387.5(47.35 to 99.68)
OG004100.0(63.06 to 100)
OG005100.0(63.06 to 100)
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
B Cells (CD19+): Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0007.40± 4.108
OG0017.89± 3.899
OG0027.24± 4.586
OG003
B Cells (CD19+): Change from Baseline to Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
B Cells (CD19+): Change from Baseline to Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0036
B Cells (CD19+): Change from Baseline to Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
B Cells (CD19+): Change from Baseline to Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0038
B Cells (CD19+): Change from Baseline to Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
B Cells (CD19+): Change from Baseline to Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
B Cells (CD19+): Change from Baseline to Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
B Cells (CD19+): Change from Baseline to Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
B Cells (CD19+): Change from Baseline to Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG003
B Cells (CD19+): Change from Baseline to Week 25
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
B Cells (CD19+): Change from Baseline to Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
B Cells (CD19+): Change from Baseline to Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
B Cells (CD19+): Change from Baseline to Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
B Cells (CD19+): Change from Baseline to Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
B Cells (CD19+): Change from Baseline to Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Memory (CD19+CD27+): Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 25
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Memory (CD19+CD27+): Change from Baseline to Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 25
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
Naïve (CD19+CD27-): Change from Baseline to Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG003
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0007.40± 4.108
OG0017.89± 3.899
OG0027.24± 4.586
OG003
Change at Pre-dose at Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
Change at Pre-dose at Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG00028.73± 12.195
OG00135.39± 4.628
OG00224.34± 12.877
OG003
Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0036
Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0037
Week 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG00016.80± 5.324
OG00117.50± 5.222
OG0029.97± 4.877
OG003
Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0036
Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0037
Week 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0000.25± 0.175
OG0010.37± 0.343
OG0020.41± 0.459
OG003
Week 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0036
Week 4
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0037
Week 12
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 20
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Week 24
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 25
ParticipantsOG0004
ParticipantsOG0017
ParticipantsOG0025
ParticipantsOG0037
Week 36
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0038
OG0048
OG0058
Title
Denominators
Categories
Baseline
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
Title
Measurements
OG0006.53± 2.829
OG0017.22± 4.469
OG0025.06± 2.618
OG003
Week 1 Day 2
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 2
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0036
Week 3 Day 15
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Week 4
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0038
Week 8
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Week 12
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Week 16
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 20
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Week 24
ParticipantsOG0008
ParticipantsOG0018
ParticipantsOG0027
ParticipantsOG0037
Week 24 Plus 2 Days
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0037
Week 25
ParticipantsOG0007
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 28
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
Week 36
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
Week 40
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0036
Week 44
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0037
Week 48
ParticipantsOG0008
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
OG003
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.
OG004
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.
OG005
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.