Study on the Effectiveness and Safety of Rozanolixizumab for Adults with Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOG-AD)

3 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This is a rare neurological disorder where the immune system mistakenly attacks a protein in the central nervous system, leading to inflammation and damage. The study is testing a treatment called Rozanolixizumab, also known by its code name UCB7665. This medication is given as a solution for injection under the skin, a method known as subcutaneous use.

The purpose of the study is to evaluate how effective and safe Rozanolixizumab is for treating adults with MOGAD. Participants in the study will be randomly assigned to receive either Rozanolixizumab or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The study will also include an open-label extension period, where all participants will have the opportunity to receive Rozanolixizumab.

Throughout the study, participants will be monitored for any changes in their condition and any side effects they may experience. The study will track the time it takes for participants to experience a relapse of their symptoms and will also record any adverse events that occur. The study aims to provide valuable information on the long-term safety and effectiveness of Rozanolixizumab for people living with MOGAD.

1 joining the study

Upon joining the study, eligibility is confirmed based on age, diagnosis, and clinical stability. Participants must be between 18 and 89 years old, have a confirmed diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD), and be clinically stable.

2 double-blind treatment period

Participants receive either the investigational medication, rozanolixizumab, or a placebo. Rozanolixizumab is administered as a 140 mg/ml solution for injection under the skin (subcutaneous use).

The primary goal is to measure the time from randomization to the first relapse. Secondary goals include changes in visual acuity and disability, as well as the number of hospitalizations related to MOG-AD.

3 open-label extension period

Participants who complete the double-blind period may enter an open-label extension period where all receive rozanolixizumab.

The focus is on monitoring the incidence of any adverse events and the annualized relapse rate.

4 monitoring and follow-up

Throughout the study, participants are regularly monitored for any side effects or changes in their condition. This includes assessments of visual acuity and disability status.

Who Can Join the Study?

  • Participants must be between 18 and 89 years old at the time of signing the informed consent.
  • Must have a confirmed diagnosis of Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD), which is a specific condition diagnosed using certain criteria.
  • Must have a history of relapsing MOG-AD, meaning the condition has come back at least once in the last 12 months, and have a positive test result for MOG antibodies using a special test called a cell-based assay (CBA) within 6 months before starting the trial.
  • Must be clinically stable, meaning their condition is not changing, at the time of the Screening Visit and during the Screening Period.

Who Cannot Join the Study?

  • Participants who do not have myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) cannot join the study. This is a specific condition related to the immune system affecting the nervous system.
  • Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population, meaning they might need special protection or care, are not eligible for this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Universitair Ziekenhuis Gent Gent Belgium
Krajska zdravotni a.s. Teplice Czechia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Fondazione Istituto G. Giglio Di Cafalu Cefalu' Italy
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Eginitio Hospital Athens Greece
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Cmqixbtew Uovubznhygefcv Smrlrbtqt Woluwe-Saint-Lambert Belgium
Semkictinrd Pxezbfajx Sirioev Kfvderyzy Nl 1 Ibzsxklmwkcvjquhlg Seyoahj Sqmjdevdj Ukvdiqclnzng Mequizjctm W Kyirenclws Zabrze Poland
Gcfpkb Rxszcqolva Rqaflbbc Cbfrck Berlin Germany
Unsstxgqxe Hhkzrktg Cxbfbsj Cologne Germany
Uecaxzkjpkadkwhxbtzvj Mtbiroag Axt Munster Germany
Uwlcqkdrtz Om Alpjcif Edegem Belgium
Hvtjippw Ucwgpyxgxazsmb Szkugumehb &usewre Hrbalyy dr Hfjgbrtcowk STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.02.2022
Czechia Czechia
Not recruiting
02.02.2022
France France
Not recruiting
02.02.2022
Germany Germany
Not recruiting
02.02.2022
Greece Greece
Not recruiting
02.02.2022
Italy Italy
Not recruiting
02.02.2022
Poland Poland
Not recruiting
02.02.2022
Portugal Portugal
Not recruiting
02.02.2022
Spain Spain
Not recruiting
02.02.2022
Sweden Sweden
Not recruiting
02.02.2022

Trial locations

Investigated drugs:

Rozanolixizumab is a medication being studied for its effectiveness in treating adults with a condition called myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD). This condition affects the nervous system, and the medication aims to help manage the symptoms by targeting specific antibodies involved in the disease. The study is designed to assess how well this medication works and how safe it is for patients.

Myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) – This is a rare neurological disorder characterized by inflammation in the central nervous system, primarily affecting the optic nerves and spinal cord. It is associated with the presence of antibodies against myelin oligodendrocyte glycoprotein, a component of the myelin sheath that insulates nerve fibers. The disease often presents with symptoms such as vision problems, muscle weakness, and sensory disturbances. MOG-AD can have a relapsing course, where symptoms may improve and then worsen again over time. The progression of the disease can vary significantly among individuals, with some experiencing frequent relapses and others having long periods of remission.

Trial ID:
2023-509237-39-00
Protocol code:
MOG001
NCT ID:
NCT05063162
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Venetoclax plus drug combination versus drug combination alone in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8
  • A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

    Recruiting

    3 1 1
    Belgium Bulgaria Denmark France Germany Greece +6