Phase 2
N=49
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02738775 ↗Enrolled (actual)
49
Serious AEs
8.2%
Results posted
Jul 2021
Primary outcome: Primary: Responder Rate of B-Cell Depletion at Week 4 — 87.5; 100.0; 87.5; 100.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ublituximab (Biological); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- TG Therapeutics, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate of B-Cell Depletion at Week 4 |
87.5; 100.0; 87.5; 100.0; 100.0; 100.0 | — |
| SECONDARY Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of New or Enlarging T2 Lesions at Weeks 24 and 48 |
0.38; 0.29; 0.00; 0.25; 0.00; 0.14 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.28; 0.00; 0.14; 0.14; 0.00; 0.00 | — |
| SECONDARY Relapse Rate Reduction (RRR) |
75.55; 100.00; 87.80; 89.04; 100.00; 100.00 | — |
| SECONDARY Percentage of Relapse Free Participants |
75.0; 100.0; 87.5; 87.5; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells |
7.40; 7.89; 7.24; 8.11; 5.71; 6.78 | — |
| SECONDARY Change From Baseline in Sustained B Cell |
7.40; 7.89; 7.24; 8.11; 5.71; 6.78 | — |
| SECONDARY Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive) |
28.73; 35.39; 24.34; 25.75; 22.70; 22.27 | — |
| SECONDARY Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive) |
16.80; 17.50; 9.97; 12.25; 8.72; 12.83 | — |
| SECONDARY Additional Immune Profiling-Interleukin 10 (IL10) |
0.25; 0.37; 0.41; 0.40; 0.13; 0.09 | — |
| SECONDARY Additional Immune Profiling-Natural Killer (NK) Cells |
6.53; 7.22; 5.06; 7.68; 5.04; 4.67 | — |
| SECONDARY Pharmacokinetic Parameter: Plasma Concentration of Ublituximab |
— | — |
Summary
This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of relapsing multiple sclerosis
- Active disease
- Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion
Exclusion Criteria
- Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months
- Treatment with alemtuzumab within the last 12 months
- Pregnant or nursing mothers
Data sourced from ClinicalTrials.gov (NCT02738775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.