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NCT05877963 Clinical Trial

Study to Evaluate Efficacy When Transitioning From a Current Disease Modifying Therapy (DMT) to Ublituximab

Relapsing Multiple Sclerosis Clinical Trial

— ENHANCE  

Official title:
Evaluating Efficacy When Transitioning From a Current Disease Modifying Therapy (DMT) to Ublituximab (ENHANCE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05877963
Other study ID # TG1101-RMS401
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 13, 2023
Est. completion date June 1, 2025

Study information
Verified date April 2024
Source TG Therapeutics, Inc.
Contact TG Therapeutics Clinical Support Team
Phone 1-877-555-8489
Email clinicalsupport@tgtxinc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this phase 3b study is to assess efficacy after transition from a current DMT to ublituximab, as measured by T1 Gadolinium (Gd)-enhancing lesions.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of RMS (2017 Revised McDonald criteria). - Participants currently treated with ocrelizumab, rituximab, ofatumumab. - Participants that are currently being treated with other selected DMTs. - Expanded Disability Status Scale (EDSS) score = 5.5 at screening. - Neurologically stable for > 30 days prior to first dose of ublituximab. Exclusion Criteria: - Suboptimal response to anti-CD20 therapy in the prior 6 months defined as 1. Documented MRI worsening (= 2 active T1-weighted Gd-enhancing lesions, any new or enlarging T2 lesions and/or 2. Clinical worsening as measured by EDSS or meaningful change in clinical measure - Relapse within the 12 months prior to W1D1. - History of any Grade > 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).

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Ublituximab
Administered as an IV infusion.

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Birmingham Alabama
United States TG Therapeutics Investigational Trial Site Boston Massachusetts
United States TG Therapeutics Investigational Trial Site Cullman Alabama
United States TG Investigational Site Farmington Michigan
United States TG Investigational Site Fort Collins Colorado
United States TG Therapeutics Investigational Trial Site Foxboro Massachusetts
United States TG Therapeutics Investigational Trial Site Golden Valley Minnesota
United States TG Therapeutics Investigational Trial Site Indianapolis Indiana
United States TG Therapeutics Investigational Trial Site Kirkland Washington
United States TG Therapeutics Investigational Trial Site Knoxville Tennessee
United States TG Therapeutics Investigational Trial Site Lutherville Maryland
United States TG Therapeutics Investigational Trial Site New York New York
United States TG Therapeutics Investigational Trial Site New York New York
United States TG Therapeutics Investigational Trial Site Oklahoma City Oklahoma
United States TG Therapeutics Investigational Trial Site Plymouth Minnesota
United States TG Therapeutics Investigational Trial Site Raleigh North Carolina
United States TG Therapeutics Investigational Trial Site Saint Louis Missouri
United States TG Therapeutics Investigational Trial Site Salt Lake City Utah
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Tampa Florida
United States TG Therapeutics Investigational Trial Site Vienna Virginia

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline up to Week 48
Secondary Percentage of Participants Free of T1 Gd-Enhancing Lesions The Gd-enhancing T1 lesions will be evaluated using MRI technique. Week 48
Secondary 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. Up to Week 48
Secondary Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness. Weeks 24 and 48
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