Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05877963
The ClinicalTrials.gov registry entry for NCT05877963 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,135-participant average among 23 other Relapsing Multiple Sclerosis trials with a reported enrollment target (63% lower). The listed sponsor is TG Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
-
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
RECRUITING · Phase 3
-
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
RECRUITING · Phase 3
-
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
RECRUITING · Phase 3
-
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.