TG1101-RMS-SC201
What it found
No result yet.
What was tested
Treatment tested
- Ublituximab
B-lymphocyte antigen CD20 binding agent
- Prefilled pen
What it measured
Main measures
Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab
Up to Week 12
How the body handles the medicineIncidence of treatment emergent adverse events (TEAE)
Safety
Other measures (6)
Part 1: Plasma Concentrations of Ublituximab
Up to Week 24
How the body handles the medicineNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 120
SafetyPart 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)
Up to Week 96
Quality of life (reported by participants)Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab
pre-dose and at multiple timepoints post-dose up to Week 120
How the body handles the medicineMaximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
pre-dose and at multiple timepoints post-dose up to Week 120
How the body handles the medicineIncidence of TEAE
Safety
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: 1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria). 2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening. 3. Neurologically stable for more than (>) 30 days prior to screening and Day 1. 4. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab. Exclusion Criteria: 1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS). 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome. 3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia. 4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening. 5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening. 6. Females who are pregnant or nursing. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
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History
Started
Apr 2026
Main results due
Jul 2027
Finished
May 2029
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