Phase 3
Completed N=549
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Relapsing Multiple Sclerosis (RMS)
Source: ClinicalTrials.gov NCT03277261 ↗
Enrolled (actual)
549
Serious AEs
9.1%
Results posted
Dec 2021
Primary outcomePrimary: Annualized Relapse Rate (ARR) — 0.076; 0.188 relapses per participant-years — p=<0.0001
◆ Published Evidence
Highly cited
199citations · ~50 / year
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.
Summary
This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.
Linked Publications (3)
-
Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis.
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Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis.
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Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) |
0.076; 0.188 | <0.0001 sig |
| SECONDARY Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant |
0.016; 0.491 | <0.0001 sig |
| SECONDARY Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant |
0.213; 2.789 | <0.0001 sig |
| SECONDARY Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks |
NA; NA | — |
| SECONDARY Percentage of Participants With No Evidence of Disease Activity (NEDA) |
44.6; 15.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT) |
29.2; 31.8 | =0.4669 |
| SECONDARY Percent Change From Baseline in Brain Volume |
-0.197; -0.125 | <0.0001 sig |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
86.1; 89.1; 11.4; 6.9 | — |
Eligibility Criteria
Inclusion Criteria
- 18-55 age
- Diagnosis of RMS (McDonald criteria 2010)
- Active disease
- Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening
Exclusion Criteria
- Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment
- Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation
- Diagnosed with Primary Progressive MS (PPMS)
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03277261) and the linked publication. 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. Informational only — not medical advice.