Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
What it found
The main measure was safety, drug levels or similar, not whether the treatment works.
“In all cohorts ( N = 48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and 48.”Read by software from the paper's abstract
B-cell depletion · week 4
Total participants: 48
Read by software from the paper's abstract
What was tested
Treatment tested
- Ublituximab
B-lymphocyte antigen CD20 binding agent
Placebo or sham
- Placebo
Results by group
Responder Rate of B-Cell Depletion at Week 4
Week 4
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cohort 1 | 87.5 percentage of participants | 47.35–99.68 | 8 |
| Cohort 2 | 100.0 percentage of participants | 63.06–100 | 8 |
| Cohort 3 | 87.5 percentage of participants | 47.35–99.68 | 8 |
| Cohort 4 | 100.0 percentage of participants | 63.06–100 | 8 |
| Cohort 5 | 100.0 percentage of participants | 63.06–100 | 8 |
| Cohort 6 | 100.0 percentage of participants | 63.06–100 | 8 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cohort 1 | 8 | 0 (0.0%) | 0 |
| Cohort 2 | 8 | 1 (12.5%) | 0 |
| Cohort 3 | 8 | 2 (25.0%) | 0 |
| Cohort 4 | 8 | 0 (0.0%) | 0 |
| Cohort 5 | 8 | 0 (0.0%) | 0 |
| Cohort 6 | 8 | 2 (25.0%) | 0 |
| Placebo | 13 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Responder Rate of B-Cell Depletion at Week 4
Week 4
Immune response
Other measures (12)
Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
Weeks 24 and 48
MRI lesionsNumber of New or Enlarging T2 Lesions at Weeks 24 and 48
Weeks 24 and 48
MRI lesionsAnnualized Relapse Rate (ARR)
Week 48
RelapsesRelapse Rate Reduction (RRR)
Baseline to Week 48
RelapsesPercentage of Relapse Free Participants
Week 48
RelapsesChange From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48
Thinking and memoryImmune responseChange From Baseline in Sustained B Cell
Baseline to pre-dose at Week 24 and Week 48
Immune responseAdditional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Immune responseAdditional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Immune responseAdditional Immune Profiling-Interleukin 10 (IL10)
Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48
Walking and mobilityImmune responseHow the body handles the medicine
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: * Diagnosis of relapsing multiple sclerosis * Active disease * Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion Exclusion Criteria: * Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months * Treatment with alemtuzumab within the last 12 months * Pregnant or nursing mothers
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
Papers
Results
A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.Mult Scler · 2021
In all cohorts ( N = 48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and 48.
Read by software from the paper's abstract
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History
Started
May 2016
Main results due
Sept 2017
Finished
Aug 2018
Results posted
Jul 2021
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