UBLITUXIMAB for Relapsing multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E study.\n- Investigator believes may benefit from treatment with ublituximab\n- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol\n- Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception"}

Exclusion criteria

• {"criterion_text":"- 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\n- Active infection\n- Ongoing pregnancy (female subjects)\n- 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.\n- 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.\n- 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.\n- Subjects with unstable disease activity\n- Presence of malignancy, except for surgically excised basal or squamous cell skin lesions\n- Vaccination with live virus within 2 months of randomization"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"ARR defined as number of relapses per subject-year; estimate = total number of relapses divided by sum of duration on study treatment (years)."}
• {"endpoint_text":"- MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy","definition_or_measurement_approach":"MRI assessments including presence of T1 Gd-enhancing lesions, T1 hypointense lesions, T2 lesions, and measures of brain atrophy (as described in MRI parameters)."}
• {"endpoint_text":"- Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score","definition_or_measurement_approach":"Disability measured by 24-week confirmed disability progression (CDP), 24-week confirmed disability improvement (CDI), and mean change from baseline in EDSS score."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"NEDA defined as absence of relapses, no MRI activity (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression; endpoint is percent of subjects meeting NEDA."}
• {"endpoint_text":"- Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)","definition_or_measurement_approach":"Cognition assessed by SDMT; function assessed by MSFC."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety assessed by reporting all AEs using NCI CTCAE v5.0; capture number/severity of infusion-associated events, infectious AEs, clinically significant lab/vital sign changes, and incidence of anti-drug antibodies."}

Croatia

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

535

Number Of Sites

3

Number Of Participants

39

Poland

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

514

Number Of Sites

8

Number Of Participants

98

Primary sponsor

Full Name

Tg Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Third parties

• {"country":"Poland","full_name":"Brillance Sp. z o.o.","duties_or_roles":"codes: 1,12,2,5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"codes: 8","organisation_type":"Industry"}
• {"country":"United States","full_name":"Veranex LLC","duties_or_roles":"codes: 7","organisation_type":"Industry"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Russian Federation","full_name":"OCT Clinical Trials","duties_or_roles":"codes: 1,2","organisation_type":"Industry"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Medicover Integrated Clinical Services Sp. z o.o.","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medrio Inc.","duties_or_roles":"codes: 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}