Study comparing subcutaneous versus intravenous ublituximab in patients with relapsing multiple sclerosis

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What is this study about?

This study focuses on patients with Relapsing Multiple Sclerosis, a condition where the immune system attacks the protective covering of nerve cells, leading to recurring episodes of neurological symptoms. The study will test a medication called ublituximab (also known as TG-1101), which is designed to target specific immune cells involved in the disease process.

The purpose of this research is to compare two different ways of giving the same medicine: under the skin (subcutaneous injection) versus directly into a vein (intravenous administration). The study will examine how the body processes the medication when given through these different methods and evaluate its effects on disease symptoms.

During the study, participants will receive ublituximab either as an injection under the skin or through an intravenous infusion. The research team will monitor the participants’ response to treatment, including how well the medication is working and any side effects that may occur. The study will track changes in participants’ condition through various medical assessments and imaging tests.

1 Initial screening

Your eligibility for the study will be evaluated based on specific criteria including:

– Age between 18 and 65 years

– Confirmed diagnosis of relapsing multiple sclerosis (RMS)

Disability status score (EDSS) of 5.5 or lower

Female participants who can become pregnant must use effective birth control during the study and for a period after the last dose

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

– Group 1: Subcutaneous ublituximab (injection under the skin)

– Group 2: Intravenous ublituximab (administration through a vein)

3 Treatment period

The study medication (ublituximab) will be given in one of two forms:

– As a solution for injection under the skin, or

– As a concentrate solution for infusion into a vein

Regular monitoring will track:

– Changes in your B-cell levels (specific type of blood cells)

– Any side effects that may occur during treatment

4 Study duration

The study is scheduled to run from September 2025 to March 2028

Your participation duration will be specified in the detailed study schedule

5 Monitoring and assessments

Throughout the study, you will undergo:

– Regular medical examinations

– Blood tests to measure drug levels in your body

– Monitoring of your multiple sclerosis symptoms

– Assessment of any side effects

Who Can Join the Study?

  • Age between 18 and 65 years old
  • Must have a confirmed diagnosis of Relapsing Multiple Sclerosis (RMS), which is a form of multiple sclerosis where symptoms come and go
  • Must have an EDSS score of 5.5 or lower during screening (EDSS is a scale that measures disability level in multiple sclerosis, where lower scores mean better physical function)
  • Both men and women can participate in the study
  • Women who can become pregnant must agree to use highly effective birth control methods during the study and for a period after receiving the last dose of the study medication

Who Cannot Join the Study?

  • History of severe allergic reactions or anaphylaxis (life-threatening allergic reaction)
  • Active or chronic infections, including hepatitis B, hepatitis C, or tuberculosis
  • Current diagnosis of cancer or history of cancer in the past 5 years (except for treated skin cancer)
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Uncontrolled high blood pressure
  • History of heart problems including heart attack or unstable heart disease
  • Pregnant or breastfeeding women
  • Use of other medications for multiple sclerosis within the past 6 months
  • Participation in other clinical trials within the past 30 days
  • History of drug or alcohol abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Inability to comply with study procedures or follow-up visits
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Krajska Nemocnice T Bati a.s. Zlin Czechia
Opca Bolnica Varazdin Varazdin Croatia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
KBC Zagreb Zagreb Croatia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Clinexpert Kft. Budapest Hungary
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD Veliko Tirnovo Bulgaria
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Poliklinika Solmed d.o.o. Zagreb Croatia
University Of Pecs Pecs Hungary
University Hospital Ostrava Ostrava Czechia
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
S-Medicon Egészségügyi Szolgáltató Kft. Budapest Hungary
Mwckpvv Cvqpzg Ausvinlpm 2tue Eyzf Pleven Bulgaria
Mcbrirz Cjizuh Mjczzf 2roq Eyfj Sofia Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
08.09.2025
Croatia Croatia
Not recruiting
08.09.2025
Czechia Czechia
Not recruiting
08.09.2025
Hungary Hungary
Not recruiting
08.09.2025

Trial locations

Investigated drugs:

Ublituximab (intravenous form) is a medication that targets specific cells in the immune system. It is administered through a vein and is used in the treatment of multiple sclerosis. This medication works by reducing the number of certain immune cells that may be involved in causing inflammation and damage to the nervous system.

Ublituximab (subcutaneous form) is the same medication but administered as an injection under the skin. This form is being tested to see if it works as effectively as the intravenous version while potentially offering more convenience to patients with multiple sclerosis.

Investigated diseases:

Multiple Sclerosis (Relapsing Form) – A chronic neurological condition affecting the central nervous system, where the immune system attacks the protective covering of nerve fibers. In the relapsing form, patients experience episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions). During relapses, patients may experience various symptoms including vision problems, muscle weakness, balance issues, and fatigue. The disease typically shows a pattern of relapses and remissions, with symptoms varying among individuals. Between relapses, patients may experience relatively stable periods with minimal or no progression of symptoms.

Trial ID:
2025-521127-73-00
Protocol code:
TG1101-RMS-SC301
Trial Phase:
Therapeutic confirmatory (Phase III)

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