RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis
About This Trial
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Diagnosis of RMS (2017 Revised McDonald criteria).
2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
3. Neurologically stable for \> 30 days prior to Screening and Day 1.
4. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab.
Who Should NOT Join This Trial:
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 weakened immune system syndrome.
3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
4. Participants who previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
Note: Other Inclusion/Exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Diagnosis of RMS (2017 Revised McDonald criteria).
2. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
3. Neurologically stable for \> 30 days prior to Screening and Day 1.
4. Female participants of childbearing potential must consent to use a highly 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 previously received anti-CD20 therapy at any time; any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
Note: Other Inclusion/Exclusion criteria may apply.
Treatments Being Tested
BIOLOGICAL
Ublituximab
Administered as an IV infusion.
BIOLOGICAL
Ublituximab
Administered as an SC injection.
Locations (20)
TG Therapeutics Investigational Trial Site
Banja Luka, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Bihać, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Mostar, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Saravejo, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Pleven, Bulgaria
TG Therapeutics Investigational Trial Site
Plovdiv, Bulgaria
TG Therapeutics Investigational Trial Site
Sofia, Bulgaria
TG Therapeutics Investigational Trial Site
Veliko Tarnovo, Bulgaria
TG Therapeutics Investigational Trial Site
Varaždin, Croatia
TG Therapeutics Investigational Trial Site
Zagreb, Croatia
TG Therapeutics Investigational Trial Site
Brno, Czechia
TG Therapeutics Investigational Trial Site
Hradec Králové, Czechia
TG Therapeutics Investigational Trial Site
Jihlava, Czechia
TG Therapeutics Investigational Trial Site
Ostrava, Czechia
TG Therapeutics Investigational Trial Site
Pardubice, Czechia
TG Therapeutics Investigational Trial Site
Zlín, Czechia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia