A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis

Official 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 with an AI device versus syringe.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 350 participants

Interventions

• DRUG: Ublituximab — Administered as an SC injection by a syringe.
• DRUG: Ublituximab — Administered as an SC injection by AI device.
• DEVICE: AI Device — Ublituximab will be administered as an SC injection by AI device.

Primary Outcomes

• Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab (Up to Week 12)

Secondary Outcomes

• 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 (Cmin) of Ublituximab (Up to Week 12)

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