A Phase 3 interventional study of Ublituximab and Teriflunomide in Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-12-06.
Sponsored by TG Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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Among 10 studies testing ublituximab in Multiple Sclerosis — 5 open to participants now, 7 under way, 4 of them phase 3. ublituximab · Multiple Sclerosis.
Among the 10 studies testing ublituximab in Multiple Sclerosis, this one is the 4th largest by enrollment, is one of 2 that started in 2017, is one of 5 in phase 3, and was the 2nd registered.
3,269 studies on the registry are indexed under Multiple Sclerosis; 663 are open to participants now.
Browse Multiple Sclerosis studies →5 of the 10 studies testing ublituximab in Multiple Sclerosis are open now, in 8 countries. Recruiting first, the newest first:
TG Therapeutics, Inc. · Sites in United States, Poland, Slovakia
Ages 10–17
TG Therapeutics, Inc. · Sites in Bosnia and Herzegovina, Georgia, North Macedonia and 3 more countries
Ages 18–65
Johns Hopkins University · Sites in United States
Ages 18–65
Northwestern University · Sites in United States
Ages 18–70
TG Therapeutics, Inc. · Sites in United States, Poland
Ages 18–65
By country, each count listing its studies:
ublituximab: first FDA approval 2022 (BRIUMVI), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 431 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 212 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 6 · Phase 4 2
First in 2016; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 545 is above the median of 50 across 2,205 interventional studies indexed under Multiple Sclerosis.
Median enrollment 355 across the 10 interventional studies. Of the 3 that completed or were terminated, 3 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 10 have an industry lead sponsor. The 3 most frequent:
TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
12 studies in Multiple Sclerosis by TG Therapeutics, Inc.: 6 open now, 9 under way, 4 of them phase 3. Of 3 finished, 3 (100%) have results posted.
Among the 12 studies in Multiple Sclerosis by TG Therapeutics, Inc., this one is one of 2 that started in 2017, is one of 5 in phase 3, and was the 2nd registered.
TG Therapeutics, Inc.’s Multiple Sclerosis studies by the year they started, since 2016.
2 of the studies testing ublituximab in Multiple Sclerosis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT07503873TG Therapeutics, Inc.A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS) | 2027-07-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 10 studies testing ublituximab in Multiple Sclerosis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among TG Therapeutics, Inc.’s 12 in Multiple Sclerosis:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants received ublituximab intravenous (IV) infusion, 150 milligrams (mg) over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo tablet, once daily (QD) from Day 1 up to the last day of Week 95.
Biological: Ublituximab · Drug: Oral Placebo
Participants received teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).
Drug: Teriflunomide · Drug: IV Placebo
Administered as an IV infusion.
Also known as: TG-1101
Film coated tablets administered orally.
Administered orally.
Administered as an IV Infusion.
Annualized Relapse Rate (ARR)
ARR is defined as the number of Independent Relapse Adjudication Committee (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.
Time frame: Up to 96 weeks
Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant
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.
Time frame: Weeks 12, 24, 48, and 96
Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant
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.
Time frame: Weeks 24, 48, and 96
Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks
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 above.
Time frame: Up to Week 96
Percentage of Participants With No Evidence of Disease Activity (NEDA)
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.
Time frame: From Week 24 to Week 96
Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)
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 of at least 4 points from baseline at any post-baseline assessment up to the Week 96 visit.
Time frame: Baseline to Week 96
Percent Change From Baseline in Brain Volume
Time frame: Baseline to Week 96
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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. TEAEs are AEs that start or worsen after receiving the study drug.
Time frame: From the first dose of study drug through the end of the study (up to approximately 116 weeks)
A total of 545 participants were enrolled across investigative sites in Belarus, Spain, the United Kingdom, Croatia, Poland, Russia, Ukraine, and the United States from 25 August 2017 to 12 November 2020.
| Milestone | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Started | 272 | 273 |
| Completed | 254 | 239 |
| Not completed | 18 | 34 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Subject withdrawal of consent | 6 | 23 |
| Withdrew: Investigator/sponsor decision | 2 | 2 |
| Withdrew: Pregnancy | 4 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Other-alternative treatment//covid-19 related/unspecified reasons | 3 | 3 |
ARR is defined as the number of Independent Relapse Adjudication Committee (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.
| relapses per participant-years | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Annualized Relapse Rate (ARR) | 0.091 (0.049 to 0.169) | 0.178 (0.109 to 0.291) |
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.
| lesions per scan per participant | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant | 0.009 (0.004 to 0.017) | 0.250 (0.162 to 0.385) |
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.
| lesions per scan per participant | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant | 0.282 (0.200 to 0.397) | 2.831 (2.128 to 3.767) |
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 above.
| weeks | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks | NA (NA to NA) | NA (NA to NA) |
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.
| percentage of participants | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Percentage of Participants With No Evidence of Disease Activity (NEDA) | 43.0 | 11.4 |
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 of at least 4 points from baseline at any post-baseline assessment up to the Week 96 visit.
| percentage of participants | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT) | 29.0 | 31.6 |
| percent change | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Percent Change From Baseline in Brain Volume | -0.194 (-0.225 to -0.164) | -0.176 (-0.207 to -0.146) |
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. TEAEs are AEs that start or worsen after receiving the study drug.
| percentage of participants | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| TEAEs | 92.3 | 93.8 |
| TESAEs | 10.3 | 7.7 |
Collected over From the first dose of study drug through the end of the study (up to approximately 116 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ublituximab + Oral Placebo | 1/272 (0.4%) | 28/272 (10.3%) | 234/272 (86%) |
| Teriflunomide + IV Placebo | 0/273 (0%) | 21/273 (7.7%) | 233/273 (85.3%) |
| Event | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| Acute sinusitisInfections and infestations | 3/272 | 0/273 |
| COVID-19 pneumoniaInfections and infestations | 2/272 | 1/273 |
| PneumoniaInfections and infestations | 2/272 | 2/273 |
| Pyelonephritis acuteInfections and infestations | 0/272 | 2/273 |
| EpilepsyNervous system disorders | 0/272 | 2/273 |
| Bone marrow toxicityBlood and lymphatic system disorders | 1/272 | 0/273 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/272 | 0/273 |
| GlaucomaEye disorders | 1/272 | 0/273 |
| Abdominal herniaGastrointestinal disorders | 1/272 | 0/273 |
| Decreased activityGeneral disorders | 1/272 | 0/273 |
| Event | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo |
|---|---|---|
| HeadacheNervous system disorders | 103/272 | 87/273 |
| NasopharyngitisInfections and infestations | 67/272 | 54/273 |
| AlopeciaSkin and subcutaneous tissue disorders | 13/272 | 48/273 |
| Back painMusculoskeletal and connective tissue disorders | 35/272 | 23/273 |
| PyrexiaGeneral disorders | 34/272 | 14/273 |
| DiarrhoeaGastrointestinal disorders | 25/272 | 32/273 |
| Respiratory tract infectionInfections and infestations | 30/272 | 28/273 |
| NauseaGastrointestinal disorders | 29/272 | 28/273 |
| Abdominal painGastrointestinal disorders | 28/272 | 12/273 |
| Influenza like illnessGeneral disorders | 28/272 | 7/273 |
Intention-to-treat (ITT) population consisted of all randomized participants.
| Age, Continuous(years) | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo | Total |
|---|---|---|---|
| Mean | 34.5 ± 8.76 | 36.2 ± 8.97 | 35.3 ± 8.90 |
| Sex: Female, Male(Participants) | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo | Total |
|---|---|---|---|
| Female | 178 | 176 | 354 |
| Male | 94 | 97 | 191 |
| Race/Ethnicity, Customized(Participants) | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo | Total |
|---|---|---|---|
| Black or African American | 2 | 3 | 5 |
| White | 269 | 269 | 538 |
| Other | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 262 | 263 | 525 |
| Not Reported | 2 | 2 | 4 |
| Unknown | 2 | 5 | 7 |
| Region of Enrollment(participants) | Ublituximab + Oral Placebo | Teriflunomide + IV Placebo | Total |
|---|---|---|---|
| Belarus | 29 | 35 | 64 |
| Spain | 6 | 2 | 8 |
| United Kingdom | 4 | 1 | 5 |
| Croatia | 25 | 24 | 49 |
| Poland | 39 | 38 | 77 |
| Russia | 78 | 85 | 163 |
| Ukraine | 74 | 69 | 143 |
| United States | 17 | 19 | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Data will be shared after study completion via publication.
Ran from Aug 2017 to primary completion in Aug 2020, 35 months.
Results were first posted in Dec 2021, 1 year 4 months after primary completion. A results delay was requested in May 2021.
Of 71 industry-sponsored phase 3 interventional studies under Multiple Sclerosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 54. This study's 35 months is below that.
Counting every sponsor, half of 96 studies reached it within 42 months; a quarter within 26 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ublituximab