Trials / Recruiting
RecruitingNCT07211633
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Detailed description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ublituximab | Administered as an IV infusion. |
| BIOLOGICAL | Ublituximab | Administered as an SC injection. |
Timeline
- Start date
- 2025-07-09
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
- First posted
- 2025-10-08
- Last updated
- 2026-04-03
Locations
42 sites across 8 countries: Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Georgia, Hungary, North Macedonia, Ukraine
Source: ClinicalTrials.gov record NCT07211633. Inclusion in this directory is not an endorsement.