Relapsing Multiple SclerosisPhase 3ENHANCENCT05877963
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 51 sites in 2 countries.
Trial summary
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 51 sitesin 2 countries
- Study dates
- 13 Jun 2023to 21 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Participants must meet one of the following prior treatment definitions:
- Participants naïve to treatment.
- Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for > 30 days prior to first dose of ublituximab.
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- Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
- Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.
- Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience
Who cannot join
- History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
- Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
- Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
- Previous serious opportunistic or atypical infection.
- Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
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- History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
- Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
- Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
- Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
- Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).
- Note: Other Inclusion/Exclusion criteria may apply.
Trial locations and contacts
51 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 2 countries
United States41 sites, 39 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30309
- Recruiting
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30322
- Recruiting
TG Therapeutics Investigational Trial Site
Birmingham, Alabama, 35209
- Recruiting
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, 00002
- Recruiting
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, 70809
- Recruiting
TG Therapeutics Investigational Trial SiteCharlotte
Charlotte, North Carolina, 28204
- Recruiting
TG Therapeutics Investigational Trial Site
Chicago, Illinois, 60612
- Recruiting
TG Therapeutics Investigational Trial Site
Cincinnati, Ohio, 45212
- Recruiting
TG Therapeutics Investigational Trial Site
Cleveland, Ohio, 44195
- Recruiting
TG Therapeutics Investigational Trial Site
Cullman, Alabama, 35058
- Recruiting
TG Therapeutics Investigational Trial Site
Dayton, Ohio, 45417
- Recruiting
TG Investigational Site
Farmington, Michigan, 48334
- Recruiting
TG Investigational Site
Fort Collins, Colorado, 80528
- Recruiting
TG Therapeutics Investigational Trial Site
Foxborough, Massachusetts, 02035
- Recruiting
TG Therapeutics Investigational Trial Site
Golden Valley, Minnesota, 55422
- Recruiting
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, 29605
- Completed
TG Therapeutics Investigational Trial Site
Houston, Texas, 77030
- Recruiting
TG Therapeutics Investigational Trial Site
Indianapolis, Indiana, 46256
- Recruiting
TG Therapeutics Investigational Trial Site
Iowa City, Iowa, 52242
- Recruiting
TG Therapeutics Investigational Trial Site
Kirkland, Washington, 98034
- Recruiting
TG Therapeutics Investigational Trial Site
Knoxville, Tennessee, 37922
- Recruiting
TG Therapeutics Investigational Trial Site
Lutherville, Maryland, 21093
- Recruiting
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, 53226
- Recruiting
TG Therapeutics Investigational Trial Site
New York, New York, 10025
- Recruiting
TG Therapeutics Investigational Trial Site
New York, New York, 11021
- Recruiting
TG Therapeutics Investigational Trial Site
North Worcester, Massachusetts, 01655
- Recruiting
TG Therapeutics Investigational Trial Site
Oklahoma City, Oklahoma, 73104
- Recruiting
TG Therapeutics Investigational Trial Site
Orange, California, 92697
- Recruiting
TG Therapeutics Investigational Trial Site
Overland Park, Kansas, 66205
- Completed
TG Therapeutics Investigational Trial Site
Overland Park, Kansas, 66212
- Recruiting
TG Therapeutics Investigational Trial Site
Plymouth, Minnesota, 55446
- Recruiting
TG Therapeutics Investigational Trial Site
Raleigh, North Carolina, 27607
- Recruiting
TG Therapeutics Investigational Trial Site
Salt Lake City, Utah, 84103
- Recruiting
TG Therapeutics Investigational Trial Site
Savannah, Georgia, 31406
- Recruiting
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98109
- Recruiting
TG Therapeutics Investigational Trial Site
Spokane, Washington, 99208
- Recruiting
TG Therapeutics Investigational Trial Site
St Louis, Missouri, 63131
- Recruiting
TG Therapeutics Investigational Trial Site
Tampa, Florida, 33612
- Recruiting
TG Therapeutics Investigational Trial Site
Vienna, Virginia, 22182
- Recruiting
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, 20007
- Recruiting
TG Therapeutics Investigational Trial Site
Wellesley, Massachusetts, 02481
Poland10 sites, 10 recruiting
- Recruiting
TG Therapeutics Investigational Trial Site
Bydgoszcz, 85-796
- Recruiting
TG Therapeutics Investigational Trial Site
Katowice, 40-555
- Recruiting
TG Therapeutics Investigational Trial Site
Kielce, 25-726
- Recruiting
TG Therapeutics Investigational Trial Site
Krakow, 31-826
- Recruiting
TG Therapeutics Investigational Trial Site
Lodz, 90-324
- Recruiting
TG Therapeutics Investigational Trial Site
Olsztyn, 10-561
- Recruiting
TG Therapeutics Investigational Trial Site
Poznan, 61-583
- Recruiting
TG Therapeutics Investigational Trial Site
Warsaw, 04-141
- Recruiting
TG Therapeutics Investigational Trial Site
Zabrze
- Recruiting
TG Therapeutics Investigational Trial Site
Żory, 44-240
About this study
Official title: Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Ublituximab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabBiological
Also called TG-1101, BRIUMVI
Administered as an intravenous (IV) infusion.
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A: Ublituximab | Experimental | Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24.
With Protocol Version 6.0, enrollment in Part A was closed. Receives: Biological: Ublituximab |
| Part B: Ublituximab /Placebo (Treatment Arm A) | Experimental | Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24.
With Protocol Version 7.0, enrollment in Part B will be closed. Receives: Biological: Ublituximab; Drug: Placebo |
| Part B: Ublituximab (Treatment Arm B) | Experimental | Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24.
With Protocol Version 7.0, enrollment in Part B will be closed. Receives: Biological: Ublituximab |
| Part C: Ublituximab (Treatment Arm C) | Experimental | Participants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24. Receives: Biological: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Measured: Baseline up to Week 48
Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab
Measured: Predose and at multiple timepoints up to Week 16
Secondary outcomes (3)
Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
The Gd-enhancing T1 lesions will be evaluated using MRI technique.
Measured: Week 48
Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
IRRs are defined as infusion related adverse events (AEs) that occur within one day of an infusion and resolve within 7 days. IRRs will be reported by investigator.
Measured: Up to Week 48
Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness.
Measured: Part A: Baseline, Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start13 Jun 2023
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877963
- Sponsor's protocol ID
- TG1101-RMS401
- Other IDs
- 2024-519284-18-00
- Acronym
- ENHANCE
- Status last verified
- Oct 2026
- First submitted
- 18 May 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )
- ClinicalTrials.gov ID
- NCT05877963
- Acronym / sponsor ID
- ENHANCE / TG1101-RMS401
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Ublituximab | Experimental | Biological: UblituximabParticipants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24. With Protocol Version 6.0, enrollment in Part A was closed. |
| Part B: Ublituximab /Placebo (Treatment Arm A) | Experimental | Biological: Ublituximab, Drug: PlaceboParticipants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed. |
| Part B: Ublituximab (Treatment Arm B) | Experimental | Biological: UblituximabParticipants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed. |
| Part C: Ublituximab (Treatment Arm C) | Experimental | Biological: UblituximabParticipants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of RMS (2017 Revised McDonald criteria).
- Participants must meet one of the following prior treatment definitions:
- Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- Neurologically stable for > 30 days prior to first dose of ublituximab.
- Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
Key exclusion criteria (12 listed)
- History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
- Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
- Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
- Previous serious opportunistic or atypical infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UblituximabAlso: TG-1101, BRIUMVIAdministered as an intravenous (IV) infusion. | Biological | Part A: Ublituximab, Part B: Ublituximab (Treatment Arm B), Part B: Ublituximab /Placebo (Treatment Arm A), Part C: Ublituximab (Treatment Arm C) |
| PlaceboIV infusion | Drug | Part B: Ublituximab /Placebo (Treatment Arm A) |
Primary outcome
Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
Time frame: Baseline up to Week 48
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab
Time frame: Predose and at multiple timepoints up to Week 16
3 secondary outcomes
Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
Time frame: Week 48
Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
Time frame: Up to Week 48
Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Time frame: Part A: Baseline, Week 24 and Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ublituximab in people with Relapsing Multiple Sclerosis, run by TG Therapeutics, Inc. at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TG Therapeutics Clinical Support Team (1-877-575-8489, clinicalsupport@tgtxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48 (time frame: Baseline up to Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.