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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
Diagnosis of RMS (2017 Revised McDonald criteria)
Participants currently treated with ocrelizumab, rituximab, ofatumumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 24 and 48
Awards & highlights

ENHANCE 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.Check my eligibility
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.See study design
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.

ENHANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with RMS according to the latest criteria.
Select...
I am currently being treated with ocrelizumab, rituximab, or ofatumumab.
Select...
My disability level allows me to walk without aid or rest for 200 meters.

ENHANCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 24 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 24 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With No Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
Secondary outcome measures
Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
Percentage of Participants Free of T1 Gd-Enhancing Lesions
Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores

ENHANCE Trial Design

1Treatment groups
Experimental Treatment
Group I: UblituximabExperimental Treatment1 Intervention
Participants will be transitioned from current anti-CD20 therapy or other DMT to receive ublituximab 450 milligram (mg) or 150 mg intravenous (IV) infusion on Day 1 of Week 1 (W1D1) and ublituximab 450 mg IV infusion at D15 (if applicable) and Week 24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~2040

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,331 Total Patients Enrolled
6 Trials studying Multiple Sclerosis
2,307 Patients Enrolled for Multiple Sclerosis

Media Library

Ublituximab Clinical Trial Eligibility Overview. Trial Name: NCT05877963 — Phase 3
Multiple Sclerosis Research Study Groups: Ublituximab
Multiple Sclerosis Clinical Trial 2023: Ublituximab Highlights & Side Effects. Trial Name: NCT05877963 — Phase 3
Ublituximab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05877963 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients given access to this experimental research?

"This medical trial is welcoming patients between 18 and 65 years of age."

Answered by AI

Is enrollment available for this clinical trial?

"Per clinicaltrials.gov, this trial is actively enrolling patients; the protocol was first made available on May 1st 2023 and has since been revised as of May 18th 2023."

Answered by AI

Who can be accepted into this clinical investigation?

"In order to be enrolled in this medical trial, a patient must have multiple sclerosis and occupy the age range of 18 - 65. Currently, there are 300 spots available for participation."

Answered by AI

How many individuals are actively participating in this medical experiment?

"Affirmative. According to the clinicaltrials.gov platform, this experiment is actively recruiting participants since being posted on May 1st 2023 and last updated 18 days later. The study intends to enroll 300 patients across two locations."

Answered by AI

Has the FDA sanctioned ublituximab for human use?

"There is prior clinical evidence proving Ublituximab's safety, thus assigning it a rating of 3."

Answered by AI
~183 spots leftby Jun 2025