A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
Study Evaluates Ublituximab for Relapsing Multiple Sclerosis
Plain English Summary
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) is a Phase 3 clinical trial sponsored by TG Therapeutics, Inc. studying Relapsing Multiple Sclerosis. Tests how well ublituximab works when given under the skin versus through a vein. For people with relapsing multiple sclerosis who are stable and not pregnant. Participation involves regular visits to the clinic and blood tests. Alternative treatments include other MS drugs. The trial aims to enroll 360 participants.
Official Summary
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible if diagnosed with relapsing MS, stable for over a month, and not pregnant. Not eligible if have progressive MS, other immune diseases, or recent blood issues. Age: 18+ years. Health: Stable condition, no active infections. 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 study measures how much ublituximab stays in the body, which helps doctors know if it’s working well. The specific primary outcome measures are: Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab (Up to Week 24). 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 fills a gap by comparing two ways to give ublituximab, potentially making treatment more convenient. 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 for MS treatments, with many competitors, but this study could lead to approval for a new form of ublituximab. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you are a good candidate for this study. You will need to visit the clinic regularly and have blood tests. 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: NONE
- Enrollment: 360 participants
Interventions
- BIOLOGICAL: Ublituximab — Administered as an IV infusion.
- BIOLOGICAL: Ublituximab — Administered as an SC injection.
Primary Outcomes
- Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab (Up to Week 24)
Secondary Outcomes
- Minimum Plasma Concentration (Cmin) of Ublituximab (Up to Week 24)
- Average Concentration at Steady State (Cavg,ss) of Ublituximab (Up to Week 120)
- Maximum Plasma Concentration (Cmax) of Ublituximab (Up to Week 120)
- Time to Maximum Plasma Concentration (Tmax) of Ublituximab (Up to Week 120)
- Last Observed Concentration (Clast) of Ublituximab (Up to Week 120)
Full Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of RMS (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening. 3. Neurologically stable for \> 30 days prior to Screening and Day 1. 4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab. Exclusion Criteria: 1. Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening. Note: Other Inclusion/Exclusion criteria may apply.
Trial Locations
- TG Therapeutics Investigational Trial Site, Banja Luka, Bosnia and Herzegovina
- TG Therapeutics Investigational Trial Site, Bihać, Bosnia and Herzegovina
- TG Therapeutics Investigational Trial Site, Mostar, Bosnia and Herzegovina
- TG Therapeutics Investigational Trial Site, Saravejo, Bosnia and Herzegovina
- TG Therapeutics Investigational Trial Site, Pleven, Bulgaria
- TG Therapeutics Investigational Trial Site, Plovdiv, Bulgaria
- TG Therapeutics Investigational Trial Site, Sofia, Bulgaria
- TG Therapeutics Investigational Trial Site, Veliko Tarnovo, Bulgaria
- TG Therapeutics Investigational Trial Site, Varaždin, Croatia
- TG Therapeutics Investigational Trial Site, Zagreb, Croatia
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07211633?
NCT07211633 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)." It is currently recruiting and is sponsored by TG Therapeutics, Inc.. The trial targets enrollment of 360 participants.
What conditions does NCT07211633 study?
This trial investigates treatments for Relapsing Multiple Sclerosis. The primary condition under study is Relapsing Multiple Sclerosis.
What treatments are being tested in NCT07211633?
The interventions being studied include: Ublituximab (BIOLOGICAL), Ublituximab (BIOLOGICAL). Administered as an IV infusion.
What does Phase 3 mean for NCT07211633?
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 NCT07211633?
This trial is currently "Recruiting." It started on 2025-07-09. The estimated completion date is 2028-12-31.
Who is sponsoring NCT07211633?
NCT07211633 is sponsored by TG Therapeutics, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07211633?
The trial aims to enroll 360 participants. The trial is currently recruiting and accepting new participants.
How is NCT07211633 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07211633?
The primary outcome measures are: Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab (Up to Week 24). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07211633 being conducted?
This trial is being conducted at 20 sites, including Banja Luka; Bihać; Mostar; Saravejo and 16 more sites (Bosnia and Herzegovina, Bulgaria, Croatia).
Where can I find official information about NCT07211633?
The official record for NCT07211633 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07211633. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07211633 testing in simple terms?
Tests how well ublituximab works when given under the skin versus through a vein. For people with relapsing multiple sclerosis who are stable and not pregnant.
Why is this trial significant?
This trial fills a gap by comparing two ways to give ublituximab, potentially making treatment more convenient. 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 NCT07211633?
Possible side effects include headache, nausea, and fatigue. Tell your doctor about any other medications you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07211633?
Ask your doctor if you are a good candidate for this study. You will need to visit the clinic regularly and have blood tests. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07211633 signal from an investment perspective?
Market size is large for MS treatments, with many competitors, but this study could lead to approval for a new form of ublituximab. 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 regular visits to the clinic and blood tests. 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.