NCT07211633Active, not recruitingPhase 3
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- TG Therapeutics, Inc.
- Enrollment
- 360
- Locations
- 48
- Primary Endpoint
- Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
Study Overview
Brief Summary
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.
Detailed Description
This is a Phase 3, open label, parallel-group, multicenter study in participants with RMS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of RMS (2017 Revised McDonald criteria).
- •Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
- •Neurologically stable for > 30 days prior to Screening and Day
- •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
- •Primary-progressive Multiple Sclerosis (PPMS) or inactive Secondary Progressive Multiple Sclerosis (SPMS).
- •Active chronic disease of the immune system other than MS or immunodeficiency syndrome.
- •Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.
- •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.
Arms & Interventions
Ublituximab SC Regimen 2
Experimental
New regimen.
Intervention: Ublituximab (Biological)
Ublituximab IV
Active Comparator
Approved dosage.
Intervention: Ublituximab (Biological)
Ublituximab SC Regimen 1
Experimental
New regimen.
Intervention: Ublituximab (Biological)
Outcomes
Primary Outcomes
Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab
Time Frame: Up to Week 24
Secondary Outcomes
- Minimum Plasma Concentration (Cmin) of Ublituximab(Up to Week 24)
- Average Concentration at Steady State (Cavg,ss) of Ublituximab(Up to Week 120)
- Maximum Plasma Concentration (Cmax) of Ublituximab(Up to Week 120)
- Time to Maximum Plasma Concentration (Tmax) of Ublituximab(Up to Week 120)
- Last Observed Concentration (Clast) of Ublituximab(Up to Week 120)
- Area Under the Curve From Week 0 to Week 120 (AUC0-120) of Ublituximab(Up to Week 120)
- Concentration From Time 0 to Time of Last Concentration (AUClast) of Ublituximab(Up to Week 120)
- Time of Last Concentration (Tlast) of Ublituximab(Up to Week 120)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Up to Week 120)
- Participants B Cell Counts(Up to Week 120)
- Total Number of Gadolinium (Gd) enhancing T1 Lesions Per Magnetic Resonance Imaging (MRI) Scan(Up to Week 96)
- Total Number of New or Enlarging T2 lesions Per MRI Scan(Up to Week 96)
Investigators
Study Sites (48)
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