Study on the Effectiveness and Safety of Fenebrutinib and Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Primary Progressive Multiple Sclerosis (PPMS). PPMS is a type of multiple sclerosis where symptoms gradually worsen over time without relapses. The study aims to compare the effectiveness and safety of two treatments: Fenebrutinib and Ocrelizumab. Fenebrutinib is taken as a film-coated tablet, while Ocrelizumab is administered as a solution for infusion, which means it is given through a vein.

The purpose of the study is to evaluate how well Fenebrutinib works compared to Ocrelizumab in treating adults with PPMS. Participants in the study will receive either Fenebrutinib, Ocrelizumab, or a placebo, which is a substance with no active medication. The study will follow participants over a period of time to observe any changes in their condition and to monitor for any side effects. The study will also look at various health measures, such as changes in brain volume using MRI scans and levels of certain proteins in the blood.

Throughout the study, participants will have regular check-ups to assess their health and the progression of their symptoms. The study will help determine which treatment is more effective in managing PPMS and provide valuable information on the safety of these medications. This research is important for improving treatment options for people living with PPMS.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

Eligibility criteria include a diagnosis of primary progressive multiple sclerosis (PPMS) and an EDSS score between 3.0 and 6.5.

2 randomization

Participants are randomly assigned to receive either fenebrutinib or ocrelizumab. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

If assigned to ocrelizumab, the participant receives an intravenous infusion of Ocrevus 300 mg at specified intervals.

If assigned to fenebrutinib, the participant takes oral tablets as directed by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the participant’s health and response to treatment. This includes physical exams, MRI scans, and blood tests.

Participants are evaluated for any changes in disability progression and other health indicators.

5 completion of study

The study is expected to conclude in May 2028. At the end of the study, final assessments are conducted to evaluate the overall efficacy and safety of the treatments.

Who Can Join the Study?

  • Ability to follow the study plan and instructions.
  • Have a diagnosis of Primary Progressive Multiple Sclerosis (PPMS) according to the updated 2017 McDonald Criteria. This means the patient has a specific type of multiple sclerosis that progresses over time.
  • Experienced worsening of disability in the 12 months before the study starts, as measured by a special questionnaire.
  • Have an EDSS score between 3.0 and 6.5 at the start of the study. The EDSS score is a way to measure how much the disease affects the patient’s ability to move and perform daily activities.
  • Have a pyramidal functional subscore of 2 or higher at the start of the study. This score relates to muscle strength and movement abilities.
  • If currently taking medications called proton pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs), the patient must be on a stable dose before and during the study. These medications are often used to reduce stomach acid.

Who Cannot Join the Study?

  • Patients who do not have Primary Progressive Multiple Sclerosis (PPMS) cannot participate. PPMS is a type of multiple sclerosis where symptoms gradually worsen over time.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients with certain other medical conditions or who are taking certain medications that might interfere with the study cannot participate. These conditions or medications are not specified here.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have a history of certain serious health issues, such as heart problems or severe infections, may not be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Universitario Puerta Del Mar Cadiz Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
401 General Military Hospital Of Athens Athens Greece
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Clinexpert Kft. Budapest Hungary
Med Polonia Sp. z o.o. Poznan Poland
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
DKD HELIOS Klinik Wiesbaden GmbH Wiesbaden Germany
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Istituto Neurologico Mediterraneo Neuromed S.p.A. Pozzilli Italy
Kepler Universitaetsklinikum GmbH Linz Austria
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hospices Civils De Lyon Lyon France
Centre Hospitalier Universitaire De Nice Nice France
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Rigshospitalet Copenhagen Denmark
Eginitio Hospital Athens Greece
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Hospital Alvaro Cunqueiro Vigo Spain
Universita Degli Studi Di Brescia Brescia Italy
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Neuroprotect Sp. z o.o. Warsaw Poland
Care Clinic Sp. z o.o. Katowice Poland
S-Medicon Egészségügyi Szolgáltató Kft. Budapest Hungary
Ntxfrm Svu z oago Rzeszow Poland
Asecufn Onhdrhdowja Uqzbuzntkcclb Ppmql Parma Italy
Smxixegpfws Pgiftvjdc Smromty Kqtmkcraz Nc 1 Isxhguugqisxvrueke Shiwnot Sxgmphaxa Utvnacjpngrm Mjrygyiusy W Kvvrtchcmn Zabrze Poland
Nuwbwkcfrv Svs z odal sqwlp Katowice Poland
Cgeyltg Nejovflckq Kkrlljcbo Smmlnu Lodz Poland
Adzshk Uvnqwnalto Hnuanksx Aarhus Denmark
Hyndgasy Vxti djrfqlqe Barcelona Spain
Hqneivdg Uljttehapqlii dl A Czigdt A Coruna Galicia Spain
Sujdfvotaouxus Dux Bxuvrba Geni Böblingen Germany
Hbiukbsl Umikbbwkwmemyu Scpfllcydl &ezmwen Hniqkiv df Hmueakilfck STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
28.12.2020
Bulgaria Bulgaria
Not recruiting
28.12.2020
Denmark Denmark
Not recruiting
28.12.2020
France France
Not recruiting
28.12.2020
Germany Germany
Not recruiting
28.12.2020
Greece Greece
Not recruiting
28.12.2020
Hungary Hungary
Not recruiting
28.12.2020
Italy Italy
Not recruiting
28.12.2020
Poland Poland
Not recruiting
28.12.2020
Portugal Portugal
Not recruiting
28.12.2020
Spain Spain
Not recruiting
28.12.2020

Trial locations

Fenebrutinib is a medication being studied for its potential to treat primary progressive multiple sclerosis (PPMS). It works by targeting specific proteins in the body that are involved in the immune response, which may help reduce inflammation and slow the progression of the disease.

Ocrelizumab is an existing treatment for primary progressive multiple sclerosis. It is a type of medication known as a monoclonal antibody, which targets and reduces certain immune cells that are believed to contribute to the damage of nerve cells in multiple sclerosis. This can help slow the progression of the disease and manage symptoms.

Investigated diseases:

Primary Progressive Multiple Sclerosis – This is a form of multiple sclerosis characterized by a gradual worsening of neurological function from the onset of symptoms, without early relapses or remissions. It primarily affects the spinal cord and brain, leading to increasing disability over time. Symptoms may include problems with walking, muscle stiffness, and weakness. Unlike other forms of multiple sclerosis, this type does not have periods of recovery, making the progression more continuous. The disease can vary greatly in its impact, with some individuals experiencing more severe symptoms than others. It is a chronic condition that affects the central nervous system, leading to a range of physical and cognitive challenges.

Trial ID:
2022-502611-10-00
Protocol code:
GN41791
Trial Phase:
Therapeutic confirmatory (Phase III)

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