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Trial Outcomes & Findings for Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (NCT NCT02738775)

NCT ID: NCT02738775

Last Updated: 2021-07-15

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Week 4

Results posted on

2021-07-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
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.
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.
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.
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.
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.
Overall Study
STARTED
8
8
8
9
8
8
Overall Study
Initially Treated With Placebo
0
0
0
1
0
0
Overall Study
COMPLETED
8
6
8
8
8
7
Overall Study
NOT COMPLETED
0
2
0
1
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
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.
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.
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.
Overall Study
Withdrawal by Subject
0
1
0
0
0
0
Overall Study
Adverse Event
0
0
0
1
0
0
Overall Study
Pregnancy
0
1
0
0
0
0
Overall Study
Missing
0
0
0
0
0
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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
n=48 Participants
Total of all reporting groups
Age, Continuous
42.4 years
STANDARD_DEVIATION 12.09 • n=5 Participants
34.3 years
STANDARD_DEVIATION 9.13 • n=7 Participants
44.9 years
STANDARD_DEVIATION 9.06 • n=5 Participants
35.1 years
STANDARD_DEVIATION 9.22 • n=4 Participants
43.5 years
STANDARD_DEVIATION 6.39 • n=21 Participants
36.5 years
STANDARD_DEVIATION 8.33 • n=8 Participants
39.4 years
STANDARD_DEVIATION 9.70 • n=8 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
8 Participants
n=21 Participants
3 Participants
n=8 Participants
32 Participants
n=8 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
3 Participants
n=4 Participants
0 Participants
n=21 Participants
5 Participants
n=8 Participants
16 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
3 Participants
n=8 Participants
9 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=5 Participants
6 Participants
n=7 Participants
7 Participants
n=5 Participants
6 Participants
n=4 Participants
7 Participants
n=21 Participants
5 Participants
n=8 Participants
39 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · Black or African American
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
7 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · White
6 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
8 Participants
n=21 Participants
6 Participants
n=8 Participants
39 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · Other
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
2 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Week 4

Population: ITT population included all participants who received at least one dose of ublituximab.

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).

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Responder Rate of B-Cell Depletion at Week 4
87.5 percentage of participants
Interval 47.35 to 99.68
100.0 percentage of participants
Interval 63.06 to 100.0
87.5 percentage of participants
Interval 47.35 to 99.68
100.0 percentage of participants
Interval 63.06 to 100.0
100.0 percentage of participants
Interval 63.06 to 100.0
100.0 percentage of participants
Interval 63.06 to 100.0

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: 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.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=7 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=7 Participants
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.
Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
Week 24
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
Week 48
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00
0.0 lesions
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: 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.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=7 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=7 Participants
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.
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
Week 24
0.38 lesions
Standard Deviation 0.52
0.29 lesions
Standard Deviation 0.49
0.00 lesions
Standard Deviation 0.00
0.25 lesions
Standard Deviation 0.71
0.00 lesions
Standard Deviation 0.00
0.14 lesions
Standard Deviation 0.38
Number of New or Enlarging T2 Lesions at Weeks 24 and 48
Week 48
0.25 lesions
Standard Deviation 0.71
0.00 lesions
Standard Deviation 0.00
0.00 lesions
Standard Deviation 0.00
0.00 lesions
Standard Deviation 0.00
0.00 lesions
Standard Deviation 0.00
0.00 lesions
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Week 48

Population: ITT population included all participants who received at least one dose of ublituximab.

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).

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Annualized Relapse Rate (ARR)
0.28 relapses per participant-years
0.00 relapses per participant-years
0.14 relapses per participant-years
0.14 relapses per participant-years
0.00 relapses per participant-years
0.00 relapses per participant-years

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: ITT population included all participants who received at least one dose of ublituximab.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Relapse Rate Reduction (RRR)
75.55 percentage reduction
100.00 percentage reduction
87.80 percentage reduction
89.04 percentage reduction
100.00 percentage reduction
100.00 percentage reduction

SECONDARY outcome

Timeframe: Week 48

Population: ITT population included all participants who received at least one dose of ublituximab.

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.

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Percentage of Relapse Free Participants
75.0 percentage of participants
Interval 34.91 to 96.81
100.0 percentage of participants
Interval 63.06 to 100.0
87.5 percentage of participants
Interval 47.35 to 99.68
87.5 percentage of participants
Interval 47.35 to 99.68
100.0 percentage of participants
Interval 63.06 to 100.0
100.0 percentage of participants
Interval 63.06 to 100.0

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline to pre-dose at Week 24 and Week 48

Population: 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.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Change From Baseline in Sustained B Cell
Baseline
7.40 percentage of cells
Standard Deviation 4.108
7.89 percentage of cells
Standard Deviation 3.899
7.24 percentage of cells
Standard Deviation 4.586
8.11 percentage of cells
Standard Deviation 2.696
5.71 percentage of cells
Standard Deviation 2.368
6.78 percentage of cells
Standard Deviation 2.097
Change From Baseline in Sustained B Cell
Change at Pre-dose at Week 24
-7.21 percentage of cells
Standard Deviation 4.068
-7.53 percentage of cells
Standard Deviation 3.399
-7.76 percentage of cells
Standard Deviation 4.478
-7.39 percentage of cells
Standard Deviation 2.940
-5.65 percentage of cells
Standard Deviation 2.377
-5.62 percentage of cells
Standard Deviation 1.992
Change From Baseline in Sustained B Cell
Change at Pre-dose at Week 48
-7.25 percentage of cells
Standard Deviation 4.086
-6.71 percentage of cells
Standard Deviation 2.854
-6.87 percentage of cells
Standard Deviation 4.542
-7.73 percentage of cells
Standard Deviation 2.621
-5.67 percentage of cells
Standard Deviation 2.342
-7.39 percentage of cells
Standard Deviation 2.174

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Baseline
28.73 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.195
35.39 cells per cubic millimeter (cells/mm^3)
Standard Deviation 4.628
24.34 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.877
25.75 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.874
22.70 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.488
22.27 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.588
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 1 Day 2
22.71 cells per cubic millimeter (cells/mm^3)
Standard Deviation 15.829
27.52 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.388
19.51 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.129
16.98 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.624
16.49 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.985
14.15 cells per cubic millimeter (cells/mm^3)
Standard Deviation 5.911
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 2
34.01 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.190
39.83 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.829
33.31 cells per cubic millimeter (cells/mm^3)
Standard Deviation 4.862
36.51 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.289
28.50 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.173
25.69 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.761
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 3 Day 15
23.74 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.399
26.51 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.650
22.60 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.766
27.68 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.656
19.88 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.902
24.57 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.080
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 4
26.19 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.922
35.31 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.530
31.47 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.658
30.97 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.840
24.62 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.087
27.59 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.016
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 8
29.74 cells per cubic millimeter (cells/mm^3)
Standard Deviation 15.735
31.46 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.387
29.64 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.204
30.95 cells per cubic millimeter (cells/mm^3)
Standard Deviation 14.625
27.73 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.162
24.59 cells per cubic millimeter (cells/mm^3)
Standard Deviation 4.511
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 12
24.20 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.152
32.26 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.118
30.98 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.476
27.71 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.209
28.03 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.045
24.09 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.087
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 16
24.03 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.040
31.55 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.557
19.19 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.466
31.27 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.131
27.37 cells per cubic millimeter (cells/mm^3)
Standard Deviation 14.733
17.85 cells per cubic millimeter (cells/mm^3)
Standard Deviation 4.155
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 20
22.94 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.492
26.87 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.629
34.25 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.928
33.56 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.537
27.17 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.908
24.51 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.149
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 24
29.24 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.678
29.36 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.856
31.33 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.406
29.12 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.006
26.71 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.603
17.41 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.523
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 24 Plus 2 Days
26.25 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.120
27.54 cells per cubic millimeter (cells/mm^3)
Standard Deviation 5.269
22.82 cells per cubic millimeter (cells/mm^3)
Standard Deviation 17.385
36.47 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.548
23.59 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.912
21.22 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.474
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 25
30.70 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.594
27.31 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.091
35.42 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.854
28.46 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.801
27.96 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.024
17.57 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.438
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 40
25.31 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.664
30.91 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.601
28.45 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.497
28.10 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.464
18.17 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.192
26.68 cells per cubic millimeter (cells/mm^3)
Standard Deviation 17.744
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 28
20.03 cells per cubic millimeter (cells/mm^3)
Standard Deviation 11.870
31.70 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.654
29.71 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.051
23.57 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.565
23.09 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.855
21.64 cells per cubic millimeter (cells/mm^3)
Standard Deviation 14.610
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 36
26.79 cells per cubic millimeter (cells/mm^3)
Standard Deviation 14.209
28.06 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.436
37.56 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.664
22.86 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.413
14.73 cells per cubic millimeter (cells/mm^3)
Standard Deviation 5.916
28.20 cells per cubic millimeter (cells/mm^3)
Standard Deviation 15.386
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 44
24.77 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.469
29.84 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.013
29.83 cells per cubic millimeter (cells/mm^3)
Standard Deviation 10.774
17.17 cells per cubic millimeter (cells/mm^3)
Standard Deviation 9.920
26.22 cells per cubic millimeter (cells/mm^3)
Standard Deviation 14.340
28.24 cells per cubic millimeter (cells/mm^3)
Standard Deviation 12.190
Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Week 48
26.72 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.914
32.92 cells per cubic millimeter (cells/mm^3)
Standard Deviation 6.697
21.90 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.779
22.60 cells per cubic millimeter (cells/mm^3)
Standard Deviation 8.935
30.85 cells per cubic millimeter (cells/mm^3)
Standard Deviation 13.016
27.03 cells per cubic millimeter (cells/mm^3)
Standard Deviation 7.844

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Baseline
16.80 cells/mm^3
Standard Deviation 5.324
17.50 cells/mm^3
Standard Deviation 5.222
9.97 cells/mm^3
Standard Deviation 4.877
12.25 cells/mm^3
Standard Deviation 2.374
8.72 cells/mm^3
Standard Deviation 3.590
12.83 cells/mm^3
Standard Deviation 6.576
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 2
17.03 cells/mm^3
Standard Deviation 3.654
16.96 cells/mm^3
Standard Deviation 7.869
13.22 cells/mm^3
Standard Deviation 3.141
14.68 cells/mm^3
Standard Deviation 2.377
11.14 cells/mm^3
Standard Deviation 4.767
14.22 cells/mm^3
Standard Deviation 9.157
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 3 Day 15
12.14 cells/mm^3
Standard Deviation 6.646
11.88 cells/mm^3
Standard Deviation 6.580
9.21 cells/mm^3
Standard Deviation 4.780
12.10 cells/mm^3
Standard Deviation 6.033
7.22 cells/mm^3
Standard Deviation 4.103
12.50 cells/mm^3
Standard Deviation 6.536
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 8
15.92 cells/mm^3
Standard Deviation 8.489
13.91 cells/mm^3
Standard Deviation 5.074
10.97 cells/mm^3
Standard Deviation 3.012
12.80 cells/mm^3
Standard Deviation 7.567
9.63 cells/mm^3
Standard Deviation 3.056
12.62 cells/mm^3
Standard Deviation 5.613
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 12
15.21 cells/mm^3
Standard Deviation 8.122
17.21 cells/mm^3
Standard Deviation 6.807
11.83 cells/mm^3
Standard Deviation 5.397
11.06 cells/mm^3
Standard Deviation 3.773
8.93 cells/mm^3
Standard Deviation 4.185
14.87 cells/mm^3
Standard Deviation 9.608
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 24 Plus 2 Days
14.70 cells/mm^3
Standard Deviation 3.655
13.28 cells/mm^3
Standard Deviation 6.727
7.05 cells/mm^3
Standard Deviation 4.656
15.52 cells/mm^3
Standard Deviation 5.839
8.90 cells/mm^3
Standard Deviation 1.508
9.41 cells/mm^3
Standard Deviation 3.298
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 36
12.92 cells/mm^3
Standard Deviation 7.721
11.95 cells/mm^3
Standard Deviation 5.493
12.46 cells/mm^3
Standard Deviation 2.840
10.11 cells/mm^3
Standard Deviation 4.527
6.92 cells/mm^3
Standard Deviation 3.158
11.59 cells/mm^3
Standard Deviation 2.584
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 40
14.63 cells/mm^3
Standard Deviation 3.687
12.77 cells/mm^3
Standard Deviation 7.654
9.82 cells/mm^3
Standard Deviation 3.926
11.59 cells/mm^3
Standard Deviation 4.485
7.93 cells/mm^3
Standard Deviation 2.207
10.30 cells/mm^3
Standard Deviation 4.027
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 48
13.28 cells/mm^3
Standard Deviation 6.673
12.79 cells/mm^3
Standard Deviation 5.232
7.42 cells/mm^3
Standard Deviation 2.276
9.86 cells/mm^3
Standard Deviation 5.260
11.68 cells/mm^3
Standard Deviation 5.757
13.50 cells/mm^3
Standard Deviation 3.412
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 1 Day 2
10.04 cells/mm^3
Standard Deviation 6.698
12.06 cells/mm^3
Standard Deviation 6.524
6.87 cells/mm^3
Standard Deviation 2.746
5.93 cells/mm^3
Standard Deviation 2.748
5.14 cells/mm^3
Standard Deviation 2.779
7.61 cells/mm^3
Standard Deviation 5.157
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 4
13.89 cells/mm^3
Standard Deviation 5.715
14.89 cells/mm^3
Standard Deviation 7.815
11.78 cells/mm^3
Standard Deviation 3.263
13.70 cells/mm^3
Standard Deviation 5.296
9.89 cells/mm^3
Standard Deviation 2.120
13.49 cells/mm^3
Standard Deviation 5.214
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 16
16.25 cells/mm^3
Standard Deviation 6.951
13.87 cells/mm^3
Standard Deviation 7.431
6.76 cells/mm^3
Standard Deviation 3.613
12.51 cells/mm^3
Standard Deviation 3.827
10.63 cells/mm^3
Standard Deviation 6.203
10.86 cells/mm^3
Standard Deviation 5.193
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 20
15.04 cells/mm^3
Standard Deviation 7.197
10.35 cells/mm^3
Standard Deviation 5.998
10.04 cells/mm^3
Standard Deviation 3.132
13.71 cells/mm^3
Standard Deviation 3.450
10.29 cells/mm^3
Standard Deviation 5.150
12.98 cells/mm^3
Standard Deviation 7.476
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 24
15.83 cells/mm^3
Standard Deviation 4.047
13.77 cells/mm^3
Standard Deviation 5.509
11.59 cells/mm^3
Standard Deviation 5.417
12.22 cells/mm^3
Standard Deviation 5.372
12.05 cells/mm^3
Standard Deviation 6.859
9.45 cells/mm^3
Standard Deviation 6.093
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 25
15.38 cells/mm^3
Standard Deviation 6.717
12.48 cells/mm^3
Standard Deviation 4.475
12.07 cells/mm^3
Standard Deviation 4.773
11.60 cells/mm^3
Standard Deviation 4.172
9.78 cells/mm^3
Standard Deviation 2.395
8.94 cells/mm^3
Standard Deviation 6.287
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 28
11.15 cells/mm^3
Standard Deviation 4.599
12.84 cells/mm^3
Standard Deviation 5.522
10.63 cells/mm^3
Standard Deviation 6.617
11.02 cells/mm^3
Standard Deviation 3.030
9.32 cells/mm^3
Standard Deviation 2.121
9.71 cells/mm^3
Standard Deviation 3.160
Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Week 44
14.41 cells/mm^3
Standard Deviation 6.085
11.46 cells/mm^3
Standard Deviation 2.451
9.91 cells/mm^3
Standard Deviation 3.937
8.67 cells/mm^3
Standard Deviation 5.073
9.59 cells/mm^3
Standard Deviation 3.922
11.87 cells/mm^3
Standard Deviation 3.352

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Additional Immune Profiling-Interleukin 10 (IL10)
Week 4
0.53 picogram per milliliter (pg/ml)
Standard Deviation 0.294
0.42 picogram per milliliter (pg/ml)
Standard Deviation 0.290
0.40 picogram per milliliter (pg/ml)
Standard Deviation 0.286
0.34 picogram per milliliter (pg/ml)
Standard Deviation 0.135
0.62 picogram per milliliter (pg/ml)
Standard Deviation 1.059
0.25 picogram per milliliter (pg/ml)
Standard Deviation 0.358
Additional Immune Profiling-Interleukin 10 (IL10)
Baseline
0.25 picogram per milliliter (pg/ml)
Standard Deviation 0.175
0.37 picogram per milliliter (pg/ml)
Standard Deviation 0.343
0.41 picogram per milliliter (pg/ml)
Standard Deviation 0.459
0.40 picogram per milliliter (pg/ml)
Standard Deviation 0.247
0.13 picogram per milliliter (pg/ml)
Standard Deviation 0.129
0.09 picogram per milliliter (pg/ml)
Standard Deviation 0.120
Additional Immune Profiling-Interleukin 10 (IL10)
Week 2
0.39 picogram per milliliter (pg/ml)
Standard Deviation 0.258
0.39 picogram per milliliter (pg/ml)
Standard Deviation 0.350
0.27 picogram per milliliter (pg/ml)
Standard Deviation 0.184
0.42 picogram per milliliter (pg/ml)
Standard Deviation 0.070
0.16 picogram per milliliter (pg/ml)
Standard Deviation 0.143
0.07 picogram per milliliter (pg/ml)
Standard Deviation 0.120
Additional Immune Profiling-Interleukin 10 (IL10)
Week 36
0.21 picogram per milliliter (pg/ml)
Standard Deviation 0.124
0.36 picogram per milliliter (pg/ml)
Standard Deviation 0.543
0.08 picogram per milliliter (pg/ml)
Standard Deviation 0.068
0.79 picogram per milliliter (pg/ml)
Standard Deviation 0.769
0.95 picogram per milliliter (pg/ml)
Standard Deviation 0.535
0.82 picogram per milliliter (pg/ml)
Standard Deviation 0.303
Additional Immune Profiling-Interleukin 10 (IL10)
Week 44
0.15 picogram per milliliter (pg/ml)
Standard Deviation 0.164
0.35 picogram per milliliter (pg/ml)
Standard Deviation 0.715
2.77 picogram per milliliter (pg/ml)
Standard Deviation 3.101
1.25 picogram per milliliter (pg/ml)
Standard Deviation 1.268
0.65 picogram per milliliter (pg/ml)
Standard Deviation 0.452
2.11 picogram per milliliter (pg/ml)
Standard Deviation 1.533
Additional Immune Profiling-Interleukin 10 (IL10)
Week 12
0.57 picogram per milliliter (pg/ml)
Standard Deviation 0.599
0.89 picogram per milliliter (pg/ml)
Standard Deviation 1.223
0.70 picogram per milliliter (pg/ml)
Standard Deviation 0.783
0.26 picogram per milliliter (pg/ml)
Standard Deviation 0.422
0.04 picogram per milliliter (pg/ml)
Standard Deviation 0.028
1.19 picogram per milliliter (pg/ml)
Standard Deviation 1.147
Additional Immune Profiling-Interleukin 10 (IL10)
Week 20
0.24 picogram per milliliter (pg/ml)
Standard Deviation 0.160
0.65 picogram per milliliter (pg/ml)
Standard Deviation 0.631
0.24 picogram per milliliter (pg/ml)
Standard Deviation 0.141
0.13 picogram per milliliter (pg/ml)
Standard Deviation 0.213
0.57 picogram per milliliter (pg/ml)
Standard Deviation 0.467
0.64 picogram per milliliter (pg/ml)
Standard Deviation 0.593
Additional Immune Profiling-Interleukin 10 (IL10)
Week 24
0.43 picogram per milliliter (pg/ml)
Standard Deviation 0.454
0.45 picogram per milliliter (pg/ml)
Standard Deviation 0.363
0.49 picogram per milliliter (pg/ml)
Standard Deviation 0.635
0.29 picogram per milliliter (pg/ml)
Standard Deviation 0.325
2.14 picogram per milliliter (pg/ml)
Standard Deviation 3.329
0.91 picogram per milliliter (pg/ml)
Standard Deviation 0.778
Additional Immune Profiling-Interleukin 10 (IL10)
Week 25
0.32 picogram per milliliter (pg/ml)
Standard Deviation 0.163
0.40 picogram per milliliter (pg/ml)
Standard Deviation 0.237
0.18 picogram per milliliter (pg/ml)
Standard Deviation 0.292
0.24 picogram per milliliter (pg/ml)
Standard Deviation 0.237
1.31 picogram per milliliter (pg/ml)
Standard Deviation 1.168
1.36 picogram per milliliter (pg/ml)
Standard Deviation 0.922
Additional Immune Profiling-Interleukin 10 (IL10)
Week 48
0.07 picogram per milliliter (pg/ml)
Standard Deviation 0.063
0.44 picogram per milliliter (pg/ml)
Standard Deviation 0.551
1.87 picogram per milliliter (pg/ml)
Standard Deviation 1.465
3.13 picogram per milliliter (pg/ml)
Standard Deviation 5.552
0.68 picogram per milliliter (pg/ml)
Standard Deviation 0.773
1.23 picogram per milliliter (pg/ml)
Standard Deviation 0.568

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Cohort 1
n=8 Participants
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.
Cohort 2
n=8 Participants
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.
Cohort 3
n=8 Participants
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.
Cohort 4
n=8 Participants
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.
Cohort 5
n=8 Participants
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.
Cohort 6
n=8 Participants
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.
Additional Immune Profiling-Natural Killer (NK) Cells
Baseline
6.53 percentage of cells/mL
Standard Deviation 2.829
7.22 percentage of cells/mL
Standard Deviation 4.469
5.06 percentage of cells/mL
Standard Deviation 2.618
7.68 percentage of cells/mL
Standard Deviation 3.724
5.04 percentage of cells/mL
Standard Deviation 2.719
4.67 percentage of cells/mL
Standard Deviation 1.946
Additional Immune Profiling-Natural Killer (NK) Cells
Week 1 Day 2
1.98 percentage of cells/mL
Standard Deviation 1.597
2.01 percentage of cells/mL
Standard Deviation 2.465
2.11 percentage of cells/mL
Standard Deviation 1.386
1.38 percentage of cells/mL
Standard Deviation 0.680
1.10 percentage of cells/mL
Standard Deviation 0.372
1.08 percentage of cells/mL
Standard Deviation 0.980
Additional Immune Profiling-Natural Killer (NK) Cells
Week 2
7.34 percentage of cells/mL
Standard Deviation 6.862
6.03 percentage of cells/mL
Standard Deviation 5.001
6.27 percentage of cells/mL
Standard Deviation 1.230
7.93 percentage of cells/mL
Standard Deviation 2.861
6.17 percentage of cells/mL
Standard Deviation 3.588
4.09 percentage of cells/mL
Standard Deviation 1.920
Additional Immune Profiling-Natural Killer (NK) Cells
Week 3 Day 15
4.99 percentage of cells/mL
Standard Deviation 1.647
6.62 percentage of cells/mL
Standard Deviation 5.840
5.63 percentage of cells/mL
Standard Deviation 2.792
5.93 percentage of cells/mL
Standard Deviation 4.679
3.50 percentage of cells/mL
Standard Deviation 1.717
4.40 percentage of cells/mL
Standard Deviation 2.570
Additional Immune Profiling-Natural Killer (NK) Cells
Week 8
6.22 percentage of cells/mL
Standard Deviation 4.761
7.53 percentage of cells/mL
Standard Deviation 4.347
6.79 percentage of cells/mL
Standard Deviation 4.172
4.80 percentage of cells/mL
Standard Deviation 2.463
4.81 percentage of cells/mL
Standard Deviation 2.573
6.21 percentage of cells/mL
Standard Deviation 4.520
Additional Immune Profiling-Natural Killer (NK) Cells
Week 16
10.49 percentage of cells/mL
Standard Deviation 5.747
5.28 percentage of cells/mL
Standard Deviation 2.548
5.91 percentage of cells/mL
Standard Deviation 3.136
5.34 percentage of cells/mL
Standard Deviation 3.057
5.58 percentage of cells/mL
Standard Deviation 4.578
7.34 percentage of cells/mL
Standard Deviation 6.747
Additional Immune Profiling-Natural Killer (NK) Cells
Week 20
10.17 percentage of cells/mL
Standard Deviation 7.791
4.46 percentage of cells/mL
Standard Deviation 2.638
6.81 percentage of cells/mL
Standard Deviation 4.994
5.73 percentage of cells/mL
Standard Deviation 2.105
5.79 percentage of cells/mL
Standard Deviation 3.144
8.03 percentage of cells/mL
Standard Deviation 7.391
Additional Immune Profiling-Natural Killer (NK) Cells
Week 24
6.70 percentage of cells/mL
Standard Deviation 4.883
6.51 percentage of cells/mL
Standard Deviation 3.781
5.84 percentage of cells/mL
Standard Deviation 2.890
4.55 percentage of cells/mL
Standard Deviation 2.243
8.51 percentage of cells/mL
Standard Deviation 5.484
9.81 percentage of cells/mL
Standard Deviation 3.968
Additional Immune Profiling-Natural Killer (NK) Cells
Week 24 Plus 2 Days
8.31 percentage of cells/mL
Standard Deviation 9.513
4.45 percentage of cells/mL
Standard Deviation 4.072
3.75 percentage of cells/mL
Standard Deviation 2.422
3.38 percentage of cells/mL
Standard Deviation 1.684
5.83 percentage of cells/mL
Standard Deviation 3.711
4.97 percentage of cells/mL
Standard Deviation 1.110
Additional Immune Profiling-Natural Killer (NK) Cells
Week 4
6.45 percentage of cells/mL
Standard Deviation 3.189
7.88 percentage of cells/mL
Standard Deviation 8.131
7.49 percentage of cells/mL
Standard Deviation 2.242
5.72 percentage of cells/mL
Standard Deviation 2.458
6.12 percentage of cells/mL
Standard Deviation 5.440
4.80 percentage of cells/mL
Standard Deviation 3.352
Additional Immune Profiling-Natural Killer (NK) Cells
Week 12
5.47 percentage of cells/mL
Standard Deviation 2.114
6.33 percentage of cells/mL
Standard Deviation 3.053
6.71 percentage of cells/mL
Standard Deviation 2.328
5.25 percentage of cells/mL
Standard Deviation 2.494
3.46 percentage of cells/mL
Standard Deviation 1.469
5.71 percentage of cells/mL
Standard Deviation 2.446
Additional Immune Profiling-Natural Killer (NK) Cells
Week 25
11.45 percentage of cells/mL
Standard Deviation 6.599
6.56 percentage of cells/mL
Standard Deviation 4.849
5.91 percentage of cells/mL
Standard Deviation 3.133
3.71 percentage of cells/mL
Standard Deviation 2.199
6.51 percentage of cells/mL
Standard Deviation 3.541
8.34 percentage of cells/mL
Standard Deviation 5.602
Additional Immune Profiling-Natural Killer (NK) Cells
Week 28
8.06 percentage of cells/mL
Standard Deviation 7.674
5.47 percentage of cells/mL
Standard Deviation 4.326
5.69 percentage of cells/mL
Standard Deviation 3.218
4.73 percentage of cells/mL
Standard Deviation 3.334
8.29 percentage of cells/mL
Standard Deviation 5.664
6.95 percentage of cells/mL
Standard Deviation 2.970
Additional Immune Profiling-Natural Killer (NK) Cells
Week 36
6.63 percentage of cells/mL
Standard Deviation 3.648
6.36 percentage of cells/mL
Standard Deviation 7.256
5.72 percentage of cells/mL
Standard Deviation 1.275
7.88 percentage of cells/mL
Standard Deviation 5.515
8.22 percentage of cells/mL
Standard Deviation 5.772
9.58 percentage of cells/mL
Standard Deviation 7.535
Additional Immune Profiling-Natural Killer (NK) Cells
Week 40
9.17 percentage of cells/mL
Standard Deviation 4.527
4.67 percentage of cells/mL
Standard Deviation 3.109
5.20 percentage of cells/mL
Standard Deviation 2.904
6.18 percentage of cells/mL
Standard Deviation 2.901
6.64 percentage of cells/mL
Standard Deviation 3.070
6.90 percentage of cells/mL
Standard Deviation 3.244
Additional Immune Profiling-Natural Killer (NK) Cells
Week 44
7.20 percentage of cells/mL
Standard Deviation 7.764
4.40 percentage of cells/mL
Standard Deviation 3.481
5.00 percentage of cells/mL
Standard Deviation 1.733
8.97 percentage of cells/mL
Standard Deviation 6.008
6.59 percentage of cells/mL
Standard Deviation 4.777
7.14 percentage of cells/mL
Standard Deviation 3.195
Additional Immune Profiling-Natural Killer (NK) Cells
Week 48
3.84 percentage of cells/mL
Standard Deviation 2.081
5.23 percentage of cells/mL
Standard Deviation 4.943
6.72 percentage of cells/mL
Standard Deviation 1.960
6.94 percentage of cells/mL
Standard Deviation 3.601
7.05 percentage of cells/mL
Standard Deviation 4.446
6.10 percentage of cells/mL
Standard Deviation 1.930

SECONDARY outcome

Timeframe: Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25

Population: 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.

Plasma concentration is defined as the measured concentration of ublituximab.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Cohort 2

Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths

Cohort 3

Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths

Cohort 4

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Cohort 5

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Cohort 6

Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1
n=8 participants at risk
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.
Cohort 2
n=8 participants at risk
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.
Cohort 3
n=8 participants at risk
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.
Cohort 4
n=8 participants at risk
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.
Cohort 5
n=8 participants at risk
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.
Cohort 6
n=8 participants at risk
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.
Placebo
n=13 participants at risk
Participant received IV infusion of placebo on Day 1 and Day 15.
Nervous system disorders
Seizure
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Diverticulum
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Appendicitis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Pregnancy, puerperium and perinatal conditions
Pregnancy
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Social circumstances
Pregnancy of partner
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.

Other adverse events

Other adverse events
Measure
Cohort 1
n=8 participants at risk
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.
Cohort 2
n=8 participants at risk
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.
Cohort 3
n=8 participants at risk
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.
Cohort 4
n=8 participants at risk
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.
Cohort 5
n=8 participants at risk
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.
Cohort 6
n=8 participants at risk
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.
Placebo
n=13 participants at risk
Participant received IV infusion of placebo on Day 1 and Day 15.
Nervous system disorders
Sensory disturbance
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Facial paralysis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Headache
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Hypoaesthesia
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Dizziness
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
23.1%
3/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Migraine
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Memory impairment
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Neuropathy peripheral
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Tremor
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Sensory loss
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Uhthoffs phenomenon
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Amnesia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Burning sensation
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Cognitive disorder
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Lethargy
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Multiple sclerosis relapse
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Muscle spasticity
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Myelitis transverse
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Neuralgia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Nystagmus
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Occipital neuralgia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Paraesthesia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Nervous system disorders
Vibratory sense increased
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Upper respiratory tract infection
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Influenza
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Sinusitis
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Nasopharyngitis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Fungal infection
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Urinary tract infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Conjunctivitis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Oral herpes
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Body tinea
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Bronchitis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Bursitis infective
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Ear infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Gastroenteritis viral
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Kidney infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Laryngitis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Localised infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Pneumonia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Staphylococcal infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Infections and infestations
Tooth infection
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Nausea
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
62.5%
5/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Diarrhoea
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Vomiting
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Constipation
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Dysphagia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Abdominal pain upper
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Dyspepsia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Toothache
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Abdominal pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Dry mouth
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Food poisoning
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Gastrointestinal disorders
Gastritis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Fatigue
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
50.0%
4/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
38.5%
5/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Pyrexia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Pain
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Chills
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Asthenia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Influenza like illness
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Infusion site pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Mass
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
General disorders
Temperature intolerance
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Arthralgia
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Back pain
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Muscle tightness
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Muscle twitching
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Cough
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
15.4%
2/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Dry throat
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Rash
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Rosacea
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Infusion related reaction
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
37.5%
3/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
23.1%
3/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Contusion
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Fall
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Skin laceration
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Injury, poisoning and procedural complications
Wrist fracture
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Psychiatric disorders
Depression
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Psychiatric disorders
Insomnia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Psychiatric disorders
Mood swings
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Psychiatric disorders
Somnambulism
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Psychiatric disorders
Stress
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Vision blurred
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Blepharospasm
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Dacryostenosis acquired
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Eye inflammation
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Eye pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Eyelid oedema
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Eye disorders
Visual impairment
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Vascular disorders
Flushing
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
25.0%
2/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Vascular disorders
Haematoma
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Vascular disorders
Hot flush
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Vascular disorders
Hypertension
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Investigations
White blood cell count decreased
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Investigations
Blood creatinine increased
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Investigations
Heart rate abnormal
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Investigations
Heart rate increased
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Investigations
Influenza B virus test positive
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Ear and labyrinth disorders
Vertigo
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Ear and labyrinth disorders
Ear pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Ear and labyrinth disorders
Eustachian tube dysfunction
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Metabolism and nutrition disorders
Dehydration
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Metabolism and nutrition disorders
Vitamin B12 deficiency
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Metabolism and nutrition disorders
Vitamin D deficiency
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Renal and urinary disorders
Bladder pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Renal and urinary disorders
Dysuria
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Renal and urinary disorders
Hypertonic bladder
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Reproductive system and breast disorders
Adenomyosis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Reproductive system and breast disorders
Vaginal odour
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Cardiac disorders
Angina pectoris
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Cardiac disorders
Coronary artery disease
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
7.7%
1/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Cardiac disorders
Cyanosis
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
Immune system disorders
Seasonal allergy
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
12.5%
1/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/8 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.
0.00%
0/13 • From the first dose of study medication through the end of the study (Up to 48 weeks)
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.

Additional Information

TG Therapeutics Clinical Support Team

TG Therapeutics

Phone: 1-877-575-8489

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place