A Study Comparing Two Forms of Ocrelizumab Given Under the Skin in Patients with Multiple Sclerosis

2 1 1 1

What is this study about?

This study is being conducted in patients with Multiple Sclerosis, which is a condition where the body’s immune system attacks the protective covering of nerves, leading to problems with movement, vision, and other body functions. The treatment being tested is ocrelizumab, which is a medicine that works by affecting certain cells in the immune system to help slow down the disease. In this study, two different formulations of ocrelizumab given under the skin will be compared, one called the test formulation and one called the reference formulation.

The purpose of this study is to determine if the test formulation of ocrelizumab works in the body in the same way as the reference formulation. During the study, participants will receive injections of ocrelizumab under the skin and will be monitored over a period of time. The study will measure how much of the medicine is in the blood and how long it stays there by taking blood samples at different times. The study will also check for any unwanted effects of the treatment and will monitor changes in vital signs, which are basic body measurements like blood pressure and heart rate, as well as results from laboratory tests of blood and other samples.

Participants will be randomly assigned to receive either the test or reference formulation of the medicine. The study is described as open-label, which means that both the participants and the doctors will know which formulation is being given. The treatment period will last for several months, and participants will be followed to collect information about how the medicine affects their body and their overall health.

1 Enrollment and randomization

Upon joining the study, you will be randomly assigned to one of two groups. Each group will receive a different subcutaneous formulation of ocrelizumab. Subcutaneous means the medication is injected under the skin.

This is an open-label study, which means both you and your doctor will know which formulation you are receiving.

2 Treatment administration

You will receive ocrelizumab injections under the skin. The dose is 920 mg per injection.

The specific schedule and frequency of injections will be determined by the study protocol and explained to you by the study staff.

The treatment will be administered at the study site.

3 Monitoring and assessments

Throughout the study, your condition will be monitored regularly. This includes assessments of your Expanded Disability Status Scale score, which measures the level of disability in multiple sclerosis.

Blood samples will be collected at specified times to measure the amount of ocrelizumab in your blood. This helps determine how your body processes the medication.

Your vital signs will be measured, including blood pressure, heart rate, and temperature. Changes from your initial measurements will be recorded.

Clinical laboratory tests will be performed, which may include blood and urine tests. Changes from your initial test results will be monitored.

4 Safety monitoring

Any adverse events will be recorded throughout the study. Adverse events are any unwanted or harmful effects that occur during treatment.

The severity of any adverse events will be assessed using a standardized grading scale.

Your safety will be continuously monitored during the entire treatment period.

5 Study completion

The study is expected to continue until December 2029.

After receiving your final dose of ocrelizumab, you will be followed for an additional 6 months.

Final assessments will be completed at the end of your participation in the study.

Who Can Join the Study?

You must be between 18 and 65 years old at the time you sign the consent form to join the study
You must have a diagnosis of relapsing multiple sclerosis (a form of multiple sclerosis where symptoms come and go) or primary progressive multiple sclerosis (a form where symptoms gradually worsen from the beginning) according to specific medical criteria from 2017 or the most recent criteria when the study begins
Your EDSS score (a scale that measures how much multiple sclerosis affects your ability to walk and perform daily activities, ranging from 0 to 10) must be between 0 and 6.5 at the time of screening
If you are a woman who can become pregnant, you must agree to either not have sexual intercourse with men or use reliable birth control methods during the study and for 6 months after receiving the last dose of the study medication
If you are a woman who cannot become pregnant, you may join the study if you have gone through menopause (the natural end of menstrual periods that happens with aging)

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this document
Generally, patients should discuss their full medical history with the study doctor to determine if they are suitable for this trial
Certain health conditions, medications, or treatments may prevent participation, but these specific details are not included in the available information
Women who are pregnant or breastfeeding (feeding a baby with breast milk) are typically not allowed to participate in clinical trials like this one
Patients with serious infections or weakened immune systems (the body’s natural defense against disease) may not be eligible
People who have had severe allergic reactions to similar medications in the past may be excluded
Patients currently participating in another clinical trial may not be able to join this study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Technische Universitaet Dresden	Dresden	Germany
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Ruhr University	Bochum	Germany
Wielospecjalistyczne Centrum Medyczne IBISMED S.C	Zabrze	Poland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Szpital Uniwersytecki w Krakowie	Cracow	Poland
Ndmpvn Stk z otkj	Rzeszow	Poland
Hyvsozoa Ucnlvzahbpvkr De Lj Phqlvyit	Madrid	Spain
Nvbjfbawmjny Cxnazg Ov Ltldyq Icvjeyii Dq Nwxkhfbzuvdi O Im Bkjpv Njxnfz Imhgsckj Dj Narjcapazpaa Sbdcsv	Rome	Italy
Pjrparsk Cftsrij Mnmvaqgv	Zory	Poland
Cnfvhhs Nyghkjltir Knjtbagbk Sfzgrs	Lodz	Poland
Adbpqfb Obblqwosltv Uvegbtfjfvlny Oiadgtvr Rjpsude	Foggia	Italy
Hdimtbaw Vxta duobnhcp	Barcelona	Spain
Iemybmmy Zikycqa Dd Bhjtxhkbxhrnxoldr	Oświęcim	Poland
Hijrmfsp Uoowakesbgwmgc Stlkefyebx &xuzxio Hryvgrn dj Hqmxsakzyjv	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	10.01.2026
Germany	Recruiting	10.01.2026
Italy	Recruiting	10.01.2026
Poland	Recruiting	10.01.2026
Spain	Recruiting	10.01.2026

Trial locations

Investigated drugs:

Ocrelizumab

Ocrelizumab is a medicine used to treat multiple sclerosis, which is a disease that affects the brain and spinal cord. In this study, two different versions of ocrelizumab given by injection under the skin will be compared to see if they work the same way in the body.

Multiple Sclerosis – Multiple Sclerosis is a chronic disease of the central nervous system that affects the brain and spinal cord. The immune system mistakenly attacks the protective covering of nerve fibers called myelin, causing communication problems between the brain and the rest of the body. This damage creates scar tissue, which gives the disease its name. The disease can cause various symptoms including numbness, weakness, vision problems, difficulty walking, and problems with coordination and balance. Symptoms may come and go in episodes called relapses, or they may gradually worsen over time. The pattern and severity of symptoms vary greatly from person to person depending on which nerves are affected.

Trial ID:

2024-517980-22-00

Protocol code:

CN45320

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A Study Comparing Two Forms of Ocrelizumab Given Under the Skin in Patients with Multiple Sclerosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?