Health Trials

A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTG Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).

Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.

Neurologically stable for more than (>) 30 days prior to screening and Day 1.

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.

Disqualifiers

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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ublituximab

    Drug

    Administered as an SC injection by a syringe.

  • Ublituximab

    Drug

    Administered as an SC injection by prefilled pen.

  • Prefilled pen

    Device

    Ublituximab will be administered as an SC injection by prefilled pen.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Part 1: Ublituximab SCExperimental treatment 1 intervention
Group B: Part 2: Ublituximab SCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to Week 12

Secondary outcomes

1

Part 1: Plasma Concentrations of Ublituximab

Time frame
Up to Week 24
2

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Up to Week 120
3

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)

Time frame
Up to Week 96
4

Part 2: Minimum Plasma Concentration at steady state (Cminss) of Ublituximab

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TG Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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