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NCT05877963 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
A Phase 3 study of Relapsing Multiple Sclerosis, sponsored by TG Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT05877963: Recruiting Phase 3 study of Relapsing Multiple Sclerosis, sponsored by TG Therapeutics.
NCT05877963 is a Phase 3 study of Relapsing Multiple Sclerosis that is actively recruiting participants, run by TG Therapeutics. The registered enrollment target is 800 participants, below the 2,135-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05877963, a Phase 3 study of Relapsing Multiple Sclerosis, is actively recruiting participants, sponsored by TG Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Primary Outcome
The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Ublituximab
Study Locations (20)
Massachusetts
- TG Therapeutics Investigational Trial Site - Boston
- TG Therapeutics Investigational Trial Site - Foxborough
- TG Therapeutics Investigational Trial Site - North Worcester
- TG Therapeutics Investigational Trial Site - Wellesley
Alabama
- TG Therapeutics Investigational Trial Site - Birmingham
- TG Therapeutics Investigational Trial Site - Cullman
Minnesota
- TG Therapeutics Investigational Trial Site - Golden Valley
- TG Therapeutics Investigational Trial Site - Plymouth
California
- TG Therapeutics Investigational Trial Site - Orange
Colorado
- TG Investigational Site - Fort Collins
District of Columbia
- TG Therapeutics Investigational Trial Site - Washington D.C.
Florida
- TG Therapeutics Investigational Trial Site - Tampa
Illinois
- TG Therapeutics Investigational Trial Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 3 |
What NCT05877963 shows while recruiting
NCT05877963 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, below the 2,135-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05877963 names 20 study sites across 15 states, led by Massachusetts, Alabama, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05877963 about?
NCT05877963 is a clinical study titled "Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab". The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhanc...
What is the current status of trial NCT05877963?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2023-06-13. Estimated completion is 2027-12-01.
What conditions does trial NCT05877963 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis.
What interventions are being tested in trial NCT05877963?
The interventions under investigation include: Placebo (DRUG), Ublituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05877963?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05877963 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Relapsing Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05877963's enrollment target sits among peer trials
800 8th of 23 higher than 16 of 23 other Relapsing Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Relapsing Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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