A Study to Evaluate the Pharmacokinetics, Pharmacodynamic... | NCT07211633

Studies
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

NCT07211633

Sponsor

TG Therapeutics, Inc.

Status

Active, not recruiting

Last Update Posted

Jun 18, 2026Actual

Enrollment

360Estimated

Phase

Phase 3

Conditions

Relapsing Multiple Sclerosis

Interventions

Ublituximab
Ublituximab

Countries

Bosnia and Herzegovina
Bulgaria
Croatia
Czechia
Georgia
Hungary
North Macedonia
Serbia
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2025-521127-73-00	Other Identifier	EU CT Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2025Actual

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Oct 1, 2025

First Submission Date that Met QC Criteria

Oct 1, 2025

First Posted Date

Oct 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ublituximab IV	Active Comparator	Approved dosage.	Biological: Ublituximab
Ublituximab SC Regimen 1	Experimental	New regimen.	Biological: Ublituximab
Ublituximab SC Regimen 2	Experimental	New regimen.	Biological: Ublituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ublituximab	Biological	Administered as an IV infusion.	Ublituximab IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab		Up to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Minimum Plasma Concentration (Cmin) of Ublituximab		Up to Week 24
Average Concentration at Steady State (Cavg,ss) of Ublituximab		Up to Week 120
Maximum Plasma Concentration (Cmax) of Ublituximab

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of RMS (2017 Revised McDonald criteria).
Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
Neurologically stable for > 30 days prior to Screening and Day 1.
Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.

Exclusion Criteria:

Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.

Note: Other Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TG Therapeutics Investigational Trial Site		Banja Luka		78000	Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms