An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Phase 3

Active, not recruiting

• Conditions: relapsing multiple sclerosis
• Interventions: Drug: ublituximab

• Registration Number: 2024-516680-91-00
• Lead Sponsor: Tg Therapeutics Inc.

Brief Summary

To evaluate the long-term safety and efficacy of ublituximab therapy in subjects with relapsing forms of MS

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 137

Inclusion Criteria

Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E study.

Investigator believes may benefit from treatment with ublituximab

Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol

Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception

Exclusion Criteria

Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: a. Absolute neutrophil count < 1.5 x 10e3/μL b. Hematocrit < 24% c. Platelet count < 150,000 cell/mm3 d. Hypogammaglobulinemia

Active infection

Ongoing pregnancy (female subjects)

Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period OR prior to completing the final Week 208 visit of the TG1101-RMS201E study.

Subjects who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, OR after the final Week 208 visit of the TG1101- RMS201E study.

Subjects who have had a confirmed MS relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, subjects must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE.

Subjects with unstable disease activity

Presence of malignancy, except for surgically excised basal or squamous cell skin lesions

Vaccination with live virus within 2 months of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ublituximab	ublituximab	Participants receiving ublituximab

Primary Outcome Measures

Name	Time	Method
Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).		Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy		MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy
Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score		Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score
No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity		No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity
Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)		Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)
Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies		Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies

Trial Locations

Locations (11)

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Klinicki Bolnicki Centar Osijek; 🇭🇷 Osijek, Croatia

Opca Bolnica Varazdin; 🇭🇷 Varazdin, Croatia

Care Clinic Sp. z o.o.; 🇵🇱 Katowice, Poland

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

Neuro-Medic Sp. z o.o.; 🇵🇱 Katowice, Poland

Wojewodzki Szpital Specjalistyczny W Olsztynie; 🇵🇱 Olsztyn, Poland

Krakowska Akademia Neurologii Sp. z o.o.; 🇵🇱 Cracow, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach; 🇵🇱 Zabrze, Poland

Ilkowski I Partnerzy sp.p. Lekarzy; 🇵🇱 Poznan, Poland

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University Hospital Centre Zagreb

🇭🇷Zagreb, Croatia

Mario Habek

Site contact

0038512420992

mario.habek@mef.hr