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

Phase 1

• Conditions: Relapsing Multiple Sclerosis; MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003625-16-HR
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-12
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study
2. Investigator believes may benefit from treatment with ublituximab
3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
4. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

1. 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 IgG < 4.0 g/L
2. Active infection
3. Ongoing pregnancy (female subjects)
4. Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period
5. Subjects who have completed TG1101-RMS301 or TG1101-RMS302 and for whom more than 180 days have elapsed since the final 96-week assessment.
6. 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 or TG1101-RMS302 study.
7. 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.
8. Subjects with unstable disease activity
9. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
10. Vaccination with live virus within 2 months of randomization

Study & Design

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