Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions and pharmacokinetics in participants with Relapsing Multiple Sclerosis (RMS). The study consists of 2 parts: Part A is single-armed and open-label and Part B is randomized, double-blind, placebo-controlled.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Diagnosis of RMS (2017 Revised McDonald criteria).

• Participants must meet one of the following prior treatment definitions:

‣ Participants naïve to treatment.

⁃ Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.

• Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.

• Neurologically stable for \> 30 days prior to first dose of ublituximab.

• Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.

Locations
United States
Alabama
TG Therapeutics Investigational Trial Site
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Birmingham
TG Therapeutics Investigational Trial Site
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Cullman
California
TG Therapeutics Investigational Trial Site
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Orange
Colorado
TG Investigational Site
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Fort Collins
Washington, D.c.
TG Therapeutics Investigational Trial Site
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Washington D.c.
Florida
TG Therapeutics Investigational Trial Site
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Tampa
Iowa
TG Therapeutics Investigational Trial Site
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Iowa City
Illinois
TG Therapeutics Investigational Trial Site
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Chicago
Indiana
TG Therapeutics Investigational Trial Site
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Indianapolis
Kansas
TG Therapeutics Investigational Trial Site
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Overland Park
Massachusetts
TG Therapeutics Investigational Trial Site
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Boston
TG Therapeutics Investigational Trial Site
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Foxborough
TG Therapeutics Investigational Trial Site
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North Worcester
TG Therapeutics Investigational Trial Site
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Wellesley
Maryland
TG Therapeutics Investigational Trial Site
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Lutherville
Michigan
TG Investigational Site
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Farmington
Minnesota
TG Therapeutics Investigational Trial Site
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Golden Valley
TG Therapeutics Investigational Trial Site
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Plymouth
Missouri
TG Therapeutics Investigational Trial Site
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St Louis
North Carolina
TG Therapeutics Investigational Trial SiteCharlotte
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Charlotte
TG Therapeutics Investigational Trial Site
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Raleigh
New York
TG Therapeutics Investigational Trial Site
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New York
TG Therapeutics Investigational Trial Site
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New York
Ohio
TG Therapeutics Investigational Trial Site
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Cleveland
TG Therapeutics Investigational Trial Site
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Dayton
Oklahoma
TG Therapeutics Investigational Trial Site
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Oklahoma City
South Carolina
TG Therapeutics Investigational Trial Site
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Greenville
Tennessee
TG Therapeutics Investigational Trial Site
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Knoxville
Texas
TG Therapeutics Investigational Trial Site
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Waco
Utah
TG Therapeutics Investigational Trial Site
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Salt Lake City
Virginia
TG Therapeutics Investigational Trial Site
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Vienna
Washington
TG Therapeutics Investigational Trial Site
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Kirkland
TG Therapeutics Investigational Trial Site
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Seattle
TG Therapeutics Investigational Trial Site
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Spokane
Wisconsin
TG Therapeutics Investigational Trial Site
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Milwaukee
Other Locations
Poland
TG Therapeutics Investigational Trial Site
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Bydgoszcz
TG Therapeutics Investigational Trial Site
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Katowice
TG Therapeutics Investigational Trial Site
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Katowice
TG Therapeutics Investigational Trial Site
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Kielce
TG Therapeutics Investigational Trial Site
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Krakow
TG Therapeutics Investigational Trial Site
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Lodz
TG Therapeutics Investigational Trial Site
RECRUITING
Olsztyn
TG Therapeutics Investigational Trial Site
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Poznan
TG Therapeutics Investigational Trial Site
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Warsaw
TG Therapeutics Investigational Trial Site
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Zabrze
TG Therapeutics Investigational Trial Site
RECRUITING
Żory
Contact Information
Primary
TG Therapeutics Clinical Support Team
clinicalsupport@tgtxinc.com
1-877-575-8489
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 600
Treatments
Experimental: Part A: Ublituximab
Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24.
Experimental: Part B: Ublituximab /Placebo (Treatment Arm A)
Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24.
Experimental: Part B: Ublituximab (Treatment Arm B)
Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24.
Sponsors
Leads: TG Therapeutics, Inc.

This content was sourced from clinicaltrials.gov