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
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.
- 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