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Recruiting NCT07503873

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)

Phase II Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ublituximab, Ublituximab, Prefilled pen.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bosnia and Herzegovina, Georgia, North Macedonia, Poland, Serbia +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Ublituximab
    Administered as an SC injection by a syringe.
  • Drug Ublituximab
    Administered as an SC injection by prefilled pen.
  • Device Prefilled pen
    Ublituximab will be administered as an SC injection by prefilled pen.

Primary outcome measures

  • Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab [Time frame: Up to Week 12]
Secondary outcome measures (5)
  • Part 1: Plasma Concentrations of Ublituximab [Time frame: Up to Week 24]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: 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) [Time frame: Up to Week 96]
  • 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]
  • Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab [Time frame: pre-dose and at multiple timepoints post-dose up to Week 120]

Eligibility criteria

Inclusion criteria

  • 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.

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 received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.
  • Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.
  • Females who are pregnant or nursing.

Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Ukraine · 20 centers
  • TG Therapeutics Investigational Trial Site — Chernihiv
  • TG Therapeutics Investigational Trial Site — Chernihiv
  • TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
  • TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
  • TG Therapeutics Investigational Trial Site — Ivano-Frankivsk
  • TG Therapeutics Investigational Trial Site — Kyiv
  • TG Therapeutics Investigational Trial Site — Kyiv
  • TG Therapeutics Investigational Trial Site — Kyiv
  • … and 12 more centers
Poland · 7 centers
  • TG Therapeutics Investigational Trial Site — Bydgoszcz
  • TG Therapeutics Investigational Trial Site — Katowice
  • TG Therapeutics Investigational Trial Site — Katowice
  • TG Therapeutics Investigational Trial Site — Kielce
  • TG Therapeutics Investigational Trial Site — Lodz
  • TG Therapeutics Investigational Trial Site — Poznan
  • TG Therapeutics Investigational Trial Site — Warsaw
Bosnia and Herzegovina · 4 centers
  • TG Therapeutics Investigational Trial Site — Bihać
  • TG Therapeutics Investigational Trial Site — Sarajevo
  • TG Therapeutics Investigational Trial Site — Tuzla
  • TG Therapeutics Investigational Trial Site — Zenica
Georgia · 4 centers
  • TG Therapeutics Investigational Trial Site — Tbilisi
  • TG Therapeutics Investigational Trial Site — Tbilisi
  • TG Therapeutics Investigational Trial Site — Tbilisi
  • TG Therapeutics Investigational Trial Site — Tbilisi
North Macedonia · 2 centers
  • TG Therapeutics Investigational Trial Site — Shtip
  • TG Therapeutics Investigational Trial Site — Skopje
Serbia · 2 centers
  • TG Therapeutics Investigational Trial Site — Belgrade
  • TG Therapeutics Investigational Trial Site — Kragujevac

Identifiers

NCT: NCT07503873 · TG1101-RMS-SC201 · 2025-523757-33-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗