NCT07503873

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (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 evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Ublituximab	Administered as an SC injection by a syringe.
DRUG	Ublituximab	Administered as an SC injection by AI device.
DEVICE	AI Device	Ublituximab will be administered as an SC injection by AI device.

Timeline

• Start date: 2026-03-21
• Primary completion: 2027-07-31
• Completion: 2029-05-30
• First posted: 2026-03-31
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study
• FDA-regulated device study