Study Comparing ABP 692 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition known as Relapsing-Remitting Multiple Sclerosis (RRMS). This is a type of multiple sclerosis where patients experience episodes of new or increasing symptoms followed by periods of partial or complete recovery. The study will compare two treatments: ABP 692 and Ocrevus (also known as ocrelizumab), which are both given as an infusion, meaning they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare how these two treatments work in the body, their effects on the disease, and their safety. Participants will receive either ABP 692 or Ocrevus, and the study will monitor how the treatments affect the number of new active brain lesions, which are areas of damage in the brain that can be seen using a special imaging technique called MRI (Magnetic Resonance Imaging). The study will last for about 48 weeks, with regular check-ups to assess the treatments’ effects and safety.

Throughout the study, participants will receive regular infusions and undergo various assessments to monitor their health and the progression of their condition. The goal is to determine if ABP 692 is as effective and safe as Ocrevus in treating RRMS. This information could help improve treatment options for people living with this condition.

1 initial assessment

The study begins with an initial assessment to confirm eligibility. This includes a diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to specific criteria, a disability score between 0 and 5.5, and recent activity of the condition.

The participant must be neurologically stable, with no relapses for at least 28 days before starting the trial.

2 randomization

Participants are randomly assigned to receive either ABP 692 or Ocrevus (ocrelizumab). This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

The treatment involves an intravenous infusion of the assigned medication. The specific product used is either Ocrevus 300 mg concentrate for solution for infusion or ABP 692.

The infusion is administered according to the study protocol, which includes monitoring the participant’s response and any side effects.

4 monitoring and follow-up

Participants are monitored for the pharmacokinetics (how the drug is processed in the body) and pharmacodynamics (the effects of the drug) over a period of 24 weeks.

Regular assessments are conducted to track the suppression of new active brain lesions using MRI scans at weeks 4, 8, 12, 16, 20, and 24.

5 completion of study

The study is estimated to conclude by July 2, 2027. Participants will have completed all required assessments and treatments by this time.

Who Can Join the Study?

  • The patient must have a diagnosis of Relapsing-remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go.
  • The patient must meet the revised McDonald Criteria 2017, which are guidelines used to diagnose multiple sclerosis.
  • The patient must have a score on the Expanded Disability Status Scale (EDSS) between 0 and 5.5. This scale measures the level of disability in people with multiple sclerosis.
  • There must be evidence of recent multiple sclerosis activity, as defined by the study protocol.
  • The patient must be neurologically stable, meaning they have not had a relapse, or worsening of symptoms, for 28 days or less before joining the study.
  • The study is open to both male and female participants.
  • The study is for adults aged 18 years and older.

Who Cannot Join the Study?

  • Patients with any other type of Multiple Sclerosis besides Relapsing-remitting Multiple Sclerosis cannot participate. Multiple Sclerosis is a condition that affects the brain and spinal cord, and relapsing-remitting means it comes and goes.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet the health requirements set by the study organizers cannot participate. These requirements ensure the safety and effectiveness of the study.

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
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Medical Center Hera EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Nimes Nimes France
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
University Hospital Bratislava Bratislava Slovakia
Algemeen Ziekenhuis Delta Roeselare Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Mtz Clinical Research Powered By Pratia Warsaw Poland
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Krajska zdravotni a.s. Teplice Czechia
Fakultna Nemocnica Trnava Trnava Slovakia
Klinische Forschung Hamburg GmbH Hamburg Germany
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
Noorderhart Pelt Belgium
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Resmedica Sp. z o.o. Kielce Poland
Ma-Lek Clinical Sp. z o.o. Katowice Poland
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Hospital Nisa Sevilla Aljarafe Castilleja De La Cuesta Spain
KBC Zagreb Zagreb Croatia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Hospital Universitario De Torrejon Torrejon De Ardoz Spain
Hospital Universitario Virgen Macarena Sevilla Spain
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Justus-Liebig-Universitaet Giessen Giessen Germany
Hospital Vithas Parque San Antonio Malaga Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
University Medical Center Ljubljana Ljubljana Slovenia
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Hospital Alvaro Cunqueiro Vigo Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Neuroprotect Sp. z o.o. Warsaw Poland
Universitaetsklinikum Leipzig AöR Leipzig Germany
Neuropraxis Muenchen Sued Unterhaching Germany
Neurologie Rs Centrum s.r.o. Hradec Kralove Czechia
MultipEL Studies Hamburg Germany
ZNS GmbH Zentrum fuer Neuro-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen Siegen Germany
Acjdmdv Cfogrry Stmcoi Bucharest Romania
Hxfftzhq Svalj Cbbhapxk Idp Salt Spain
Cgedcq Hfipisjmgrn Ulcizhehhmmjw Rvooy Reims France
Uulcdnzogchwdkynehuic Ekhvm Axg Essen Germany
Ewggamx sq ry oa Bratislava Slovakia
Cnid Dp Czlh Itnh Sncglw Milan Italy
Nljhzuvqpu Syz z opcb sopnb Katowice Poland
Bpfjxfap Cvroqp Sdrnbu Constanta Romania
Hkvlyczr Udcobpxthtfkn Ruxvnvzs Du Mritec Malaga Spain
Hutkywdt Urmyipnrfpdyv Fewakdlxq Ahfssfhu Madrid Spain
Hlrrxvdx dp Dqdyh Denia Spain
Axpkmez Oghuottyrfl Uawydbuguxggr Syxsku Siena Italy
Auvkgl Urbxkuljvv Hyblpbpt Aarhus Denmark
Rkfjkcmxthnvei Glostrup Denmark
Uynpvqrvzq Of Agjqsta Edegem Belgium
Cxokipr Nzyslbphba Kddkixgvd Skzjbr Lodz Poland
Scldlzolphbwtc Drm Bmsqpnc Gidk Böblingen Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.03.2025
Bulgaria Bulgaria
Not recruiting
15.03.2025
Croatia Croatia
Not recruiting
15.03.2025
Czechia Czechia
Not recruiting
15.03.2025
Denmark Denmark
Not recruiting
15.03.2025
France France
Not recruiting
15.03.2025
Germany Germany
Not recruiting
15.03.2025
Italy Italy
Not recruiting
15.03.2025
Lithuania Lithuania
Not yet recruiting
15.03.2025
Poland Poland
Not recruiting
15.03.2025
Romania Romania
Not recruiting
15.03.2025
Slovakia Slovakia
Not recruiting
15.03.2025
Slovenia Slovenia
Not recruiting
15.03.2025
Spain Spain
Not recruiting
15.03.2025
Sweden Sweden
Not yet recruiting
15.03.2025

Trial locations

Investigated drugs:

ABP 692 is an investigational medication being studied for its effects on relapsing-remitting multiple sclerosis. It is being compared to an existing treatment to see if it works in a similar way in the body and has similar effects on the disease.

Ocrevus® (Ocrelizumab) is a medication already approved for the treatment of relapsing-remitting multiple sclerosis. It works by targeting specific cells in the immune system to reduce inflammation and prevent new brain lesions, which are common in multiple sclerosis. This study is comparing the effects of ABP 692 to Ocrevus® to ensure they are similar in terms of how they work and their safety profiles.

Relapsing-remitting Multiple Sclerosis – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, individuals may experience symptoms such as vision problems, muscle weakness, or coordination difficulties. These symptoms can vary in severity and duration. After a relapse, there is a remission phase where symptoms may improve or disappear entirely. However, over time, some symptoms may persist and accumulate, leading to gradual disability. The disease course is unpredictable, with the frequency and severity of relapses varying among individuals.

Trial ID:
2024-512914-16-00
Protocol code:
20230309
Trial Phase:
Therapeutic confirmatory (Phase III)

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