RecruitingPhase 2Relapsing MSNCT075038732025-523757-33-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ublituximab

    B-lymphocyte antigen CD20 binding agent

  • Prefilled pen

What it measured

Main measures

  • Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab

    Up to Week 12

    How the body handles the medicine
  • Incidence of treatment emergent adverse events (TEAE)

    Safety

Other measures (6)

  • Part 1: Plasma Concentrations of Ublituximab

    Up to Week 24

    How the body handles the medicine
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Up to Week 120

    Safety
  • 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

    Quality of life (reported by participants)
  • Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab

    pre-dose and at multiple timepoints post-dose up to Week 120

    How the body handles the medicine
  • Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab

    pre-dose and at multiple timepoints post-dose up to Week 120

    How the body handles the medicine
  • Incidence of TEAE

    Safety

Who could take part

Relapsing MS · 18 to 65

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/Exclusion criteria may apply.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Apr 2026

    2. Main results due

      Jul 2027

    3. Finished

      May 2029

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