An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT04130997
• Date of registration: 16/10/2019
• Prospective Registration: Yes
• Primary sponsor: TG Therapeutics, Inc.
• Public title: An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
• Scientific title: An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: November 18, 2019
• Target sample size: 1100
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04130997
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belarus, Croatia, Georgia, Poland, Russian Federation, Serbia, Ukraine, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

Participants must meet the following criteria:

1. Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302
(NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E
(NCT03381170) 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 participants 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

Exclusion Criteria:

Participants who meet any of the following exclusion criteria are not to be enrolled to
this study:

1. Any significant or uncontrolled medical condition or treatment-emergent, clinically
significant laboratory abnormality such as:

1. Absolute neutrophil count < 1.5 x 10e3/µL

2. Hematocrit < 24%

3. Platelet count < 150,000 cell/mm^3

4. Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L

2. Active infection

3. Ongoing pregnancy (female participants)

4. Participants 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

5. Participants 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
completing the final Week 208 visit of the TG1101-RMS201E study

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

7. Participants with unstable disease activity

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

9. Vaccination with live virus within 2 months of randomization



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis (RMS)

Intervention(s)

Biological: Ublituximab

Primary Outcome(s)

Annualized Relapse Rate (ARR) [Time Frame: Up to Week 336]

Secondary ID(s)

2019-003625-16

TG1101-RMS303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors