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

Phase 3

Recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Biological: Ublituximab

• Registration Number: NCT05877963
• Lead Sponsor: TG Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Study Start: 2023-06-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ublituximab	Ublituximab	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.

Primary Outcome Measures

Name	Time	Method
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	The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Free of T1 Gd-Enhancing Lesions	Week 48	The Gd-enhancing T1 lesions will be evaluated using MRI technique.
Percentage of Participants Experiencing Infusion Related Reactions (IRRs)	Up to Week 48	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.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores	Baseline Up to Week 48	The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness.
Serum Concentration of Ublituximab	Up to Week 48

Trial Locations

Locations (3)

TG Therapeutics Investigational Trial SiteCharlotte; 🇺🇸 Charlotte, North Carolina, United States

TG Therapeutics Investigational Trial Site; 🇺🇸 Spokane, Washington, United States

TG Investigational Site; 🇺🇸 Farmington, Michigan, United States