Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )
Study to Evaluate Ublituximab for Relapsing Multiple Sclerosis
Plain English Summary
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab is a Phase 3 clinical trial sponsored by TG Therapeutics, Inc. studying Relapsing Multiple Sclerosis. Tests a new regimen of ublituximab to reduce brain lesions in people with relapsing multiple sclerosis (RMS). For adults with RMS who have had previous treatments or are new to treatment. Participation involves IV infusions at study sites across the U.S. over 48 weeks. Alternative treatments include other MS drugs like alemtuzumab, mitoxantrone, and cladribine. The trial aims to enroll 800 participants.
Official 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 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if diagnosed with RMS, no serious infusion reactions, and no other active immune diseases. Not eligible if have progressive MS, active infections, or history of certain cancers. Age: 18+ years. Health: Stable neurologically, no active infections, no other serious conditions. This trial is studying Relapsing Multiple Sclerosis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the reduction in brain lesions, which can help patients by slowing disease progression. The specific primary outcome measures are: 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 (Baseline up to Week 48); Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab (Predose and at multiple timepoints up to Week 16). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a gap in treatment options for RMS patients who haven't responded well to previous therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Relapsing Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
Market size is large, with many patients needing new treatment options, and approval is likely given the unmet need. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 800 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the RMS criteria and have had a suboptimal response to previous treatments. Participation involves regular IV infusions and clinic visits over 48 weeks. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 800 participants
Interventions
- BIOLOGICAL: Ublituximab — Administered as an intravenous (IV) infusion.
- DRUG: Placebo — IV infusion
Primary Outcomes
- 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 (Baseline up to Week 48)
- Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab (Predose and at multiple timepoints up to Week 16)
Secondary Outcomes
- Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions (Week 48)
- Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs) (Up to Week 48)
- Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores (Part A: Baseline, Week 24 and Week 48)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of RMS (2017 Revised McDonald criteria). * Participants must meet one of the following prior treatment definitions: 1. Participants naïve to treatment. 2. 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. * 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 Exclusion Criteria: * 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). * 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
- TG Therapeutics Investigational Trial Site, Birmingham, Alabama, United States
- TG Therapeutics Investigational Trial Site, Cullman, Alabama, United States
- TG Therapeutics Investigational Trial Site, Orange, California, United States
- TG Investigational Site, Fort Collins, Colorado, United States
- TG Therapeutics Investigational Trial Site, Washington D.C., District of Columbia, United States
- TG Therapeutics Investigational Trial Site, Tampa, Florida, United States
- TG Therapeutics Investigational Trial Site, Chicago, Illinois, United States
- TG Therapeutics Investigational Trial Site, Indianapolis, Indiana, United States
- TG Therapeutics Investigational Trial Site, Iowa City, Iowa, United States
- TG Therapeutics Investigational Trial Site, Overland Park, Kansas, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05877963?
NCT05877963 is a Phase 3 INTERVENTIONAL study titled "Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab." It is currently recruiting and is sponsored by TG Therapeutics, Inc.. The trial targets enrollment of 800 participants.
What conditions does NCT05877963 study?
This trial investigates treatments for Relapsing Multiple Sclerosis. The primary condition under study is Relapsing Multiple Sclerosis.
What treatments are being tested in NCT05877963?
The interventions being studied include: Ublituximab (BIOLOGICAL), Placebo (DRUG). Administered as an intravenous (IV) infusion.
What does Phase 3 mean for NCT05877963?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT05877963?
This trial is currently "Recruiting." It started on 2023-06-13. The estimated completion date is 2027-12-01.
Who is sponsoring NCT05877963?
NCT05877963 is sponsored by TG Therapeutics, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05877963?
The trial aims to enroll 800 participants. The trial is currently recruiting and accepting new participants.
How is NCT05877963 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05877963?
The primary outcome measures are: 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 (Baseline up to Week 48); Part B: Area Under the Curve Over the First 16 Weeks (AUC0-W16) of Ublituximab (Predose and at multiple timepoints up to Week 16). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05877963 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Cullman, Alabama; Orange, California; Fort Collins, Colorado and 16 more sites (United States).
Where can I find official information about NCT05877963?
The official record for NCT05877963 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05877963. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05877963 testing in simple terms?
Tests a new regimen of ublituximab to reduce brain lesions in people with relapsing multiple sclerosis (RMS). For adults with RMS who have had previous treatments or are new to treatment.
Why is this trial significant?
This trial addresses a gap in treatment options for RMS patients who haven't responded well to previous therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT05877963?
Potential risks include infusion reactions and other side effects like headache, nausea, and fatigue. Monitor for any signs of infection or worsening symptoms during the study. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05877963?
Ask your doctor if you meet the RMS criteria and have had a suboptimal response to previous treatments. Participation involves regular IV infusions and clinic visits over 48 weeks. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05877963 signal from an investment perspective?
Market size is large, with many patients needing new treatment options, and approval is likely given the unmet need. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves IV infusions at study sites across the U.S. over 48 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Relapsing Multiple Sclerosis Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.