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Ublituximab for Multiple Sclerosis (ENHANCE Trial)
Phase 3
Recruiting
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will study how well a new drug, ublituximab, maintains effectiveness after switching from a current anti-CD20 treatment for Multiple Sclerosis.
Who is the study for?
This trial is for people with Relapsing Multiple Sclerosis (RMS) who've been stable on anti-CD20 therapy like ocrelizumab or rituximab. They should have an EDSS score ≤ 5.5 and diagnosed within the last 10 years. Exclusions include recent relapses, certain infections, vaccine restrictions, IVIG treatments in the past year, severe infusion reactions to previous therapies, and other active immune diseases.
What is being tested?
The study tests if switching from current anti-CD20 therapies to Ublituximab maintains its effectiveness against MS. Effectiveness is measured by checking brain lesions using a special MRI scan that highlights active inflammation.
What are the potential side effects?
While not specified here, side effects of Ublituximab may be similar to other anti-CD20 drugs: infusion reactions, increased risk of infections due to weakened immune response, potential liver issues indicated by hepatitis B reactivation risk mentioned in exclusions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With No Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
Secondary study objectives
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
Percentage of Participants Free of T1 Gd-Enhancing Lesions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: UblituximabExperimental Treatment1 Intervention
Participants will receive a modified regimen of ublituximab intravenous (IV) including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) IV infusion at Week 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~1490
Find a Location
Who is running the clinical trial?
TG Therapeutics, Inc.Lead Sponsor
39 Previous Clinical Trials
6,558 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
3,535 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received any live vaccines in the last 4 weeks.My condition is either PPMS or inactive SPMS.I have or had hepatitis B or C, but if C, my PCR test for the virus is negative.My condition worsened after anti-CD20 therapy, shown by recent MRI and/or clinical assessments.I have had a serious unusual infection before.I have or might have a brain infection known as PML.I have been diagnosed with RMS according to the latest criteria.My neurological condition has been stable for over a month.I have a chronic immune system condition other than MS, or an immunodeficiency syndrome.I do not have any long-term infections requiring ongoing treatment.I have never taken ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab for any condition.I am currently being treated with ocrelizumab, rituximab, or ofatumumab.My disability level allows me to walk without aid or rest for 200 meters.I have had a severe reaction to previous anti-CD20 therapy.I have no active cancer except for treated skin cancer or in situ carcinoma.My condition worsened again less than a year ago.I needed IVIG treatment for low immunoglobulins in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Ublituximab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.