Adults 18 to 55, any sex, with Relapsing Multiple Sclerosis (RMS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Annualized Relapse Rate (ARR)Primary· Up to 96 weeks
ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.
Group
Value
95% CI
Ublituximab + Oral Placebo
0.076
0.042 – 0.138
Teriflunomide + IV Placebo
0.188
0.124 – 0.283
Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per ParticipantSecondary· Weeks 12, 24, 48, and 96
The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain.
Group
Value
95% CI
Ublituximab + Oral Placebo
0.016
0.008 – 0.032
Teriflunomide + IV Placebo
0.491
0.355 – 0.679
Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per ParticipantSecondary· Weeks 24, 48, and 96
The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain.
Group
Value
95% CI
Ublituximab + Oral Placebo
0.213
0.144 – 0.316
Teriflunomide + IV Placebo
2.789
2.136 – 3.643
Time to Confirmed Disability Progression (CDP) for at Least 12 WeeksSecondary· Up to Week 96
12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is \>5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined abov
Group
Value
95% CI
Ublituximab + Oral Placebo
NA
NA – NA
Teriflunomide + IV Placebo
NA
NA – NA
Percentage of Participants With No Evidence of Disease Activity (NEDA)Secondary· Week 24 up to Week 96
A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted.
Group
Value
95% CI
Ublituximab + Oral Placebo
44.6
Teriflunomide + IV Placebo
15.0
Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)Secondary· Baseline up to Week 96
The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease from baseline of at least 4 points at any post-baseline assessment up to the Week 96 visit.
Group
Value
95% CI
Ublituximab + Oral Placebo
29.2
Teriflunomide + IV Placebo
31.8
Percent Change From Baseline in Brain VolumeSecondary· Baseline up to Week 96
Group
Value
95% CI
Ublituximab + Oral Placebo
-0.197
-0.228 – -0.166
Teriflunomide + IV Placebo
-0.125
-0.155 – -0.095
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)Secondary· From the first dose of study drug through the end of the study (up to approximately 116 weeks)
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that starts or worse
TEAEs
Group
Value
95% CI
Ublituximab + Oral Placebo
86.1
Teriflunomide + IV Placebo
89.1
TESAEs
Group
Value
95% CI
Ublituximab + Oral Placebo
11.4
Teriflunomide + IV Placebo
6.9
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug through the end of the study (up to approximately 116 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· not yet recruiting
NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
· NA
· not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection
· Phase 2
· not yet recruiting
NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
· Phase 4
· recruiting
NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis
· EARLY_PHASE1
· recruiting
Other recruiting trials for Relapsing Multiple Sclerosis (RMS)
Currently open trials in the same condition.
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· Phase 3
· active not recruiting
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NCT04130997 — An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
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Other TG Therapeutics, Inc. trials
Trials by the same sponsor.
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection
· Phase 2
· not yet recruiting
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub
· Phase 3
· recruiting
NCT06680037 — A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
· Phase 1
· recruiting
NCT06433752 — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Mult
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TG Therapeutics, Inc.
Last refreshed: 6 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03277261.