Phase 3
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)
Bottom Line
View on ClinicalTrials.gov: NCT03277261 ↗Enrolled (actual)
549
Serious AEs
9.1%
Results posted
Dec 2021
Primary outcome: Primary: Annualized Relapse Rate (ARR) — 0.076; 0.188 relapses per participant-years — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ublituximab (Biological); Teriflunomide (Drug); Oral Placebo (Drug); IV Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- TG Therapeutics, Inc.
- Primary completion
- Jul 2020
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 | — |
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.
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). 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.