Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGUblituximab
Administered as an SC injection by a syringe.
DEVICEPrefilled pen
Ublituximab will be administered as an SC injection by prefilled pen.
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab | Up to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Plasma Concentrations of Ublituximab | Up to Week 24 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Week 120 |
| Part 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 |
| Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab | pre-dose and at multiple timepoints post-dose up to Week 120 |
| Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab | pre-dose and at multiple timepoints post-dose up to Week 120 |
Countries
Bosnia and Herzegovina, Georgia, North Macedonia, Poland, Serbia, Ukraine
Contacts
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed