An Extension of the TG1101-RMS201 Trial | NCT03381170

Studies
An Extension of the TG1101-RMS201 Trial

NCT03381170

Sponsor

TG Therapeutics, Inc.

Status

Completed

Last Update Posted

Dec 21, 2022Actual

Enrollment

48Actual

Phase

Phase 2

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Ublituximab

Countries

United States

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Nov 11, 2022Actual

Completion Date

Nov 11, 2022Actual

First Submitted Date

Dec 18, 2017

First Submission Date that Met QC Criteria

Dec 18, 2017

First Posted Date

Dec 21, 2017Actual

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

Dec 20, 2022

Last Update Posted Date

Dec 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ublituximab	Experimental	Ublituximab IV infusions on Weeks 1E, 24E, 48E, 72E and (6E	Biological: Ublituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ublituximab	Biological	Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E	Ublituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related events as assessed by CTCAE V4.0	to determine the incidence of adverse events and any abnormal laboratory values	96 weeks on therapy

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the % of participants with relapses		up to 96 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects currently enrolled in TG1101-RMS201 trial
Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit

Exclusion Criteria:

Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period
Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial
Pregnant or nursing mothers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

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		Pasadena	California	91105	United States
TG Therapeutics Investigational Trial Site

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data will be shared after study completion via publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000619007	ublituximab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided