A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
TG Therapeutics, Inc.
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
Clareo Health | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
