For healthcare providers
The cosMOG clinical research study
The cosMOG study is a randomized, double-blind, placebo-controlled, phase 3 study with an open-label extension period to evaluate the efficacy and tolerability of an investigational drug in people with myelin oligodendrocyte glycoprotein antibody-associated disease (MOG‑AD).
The investigational drug, rozanolixizumab, is an antibody made to work as a medicine by reducing immunoglobulin G (IgG) antibodies that are involved in MOG‑AD.
We are looking for about 100 people worldwide who (among other criteria):
- Are between 18 and 89 years old
- Have a confirmed diagnosis of MOG‑AD consistent with published diagnostic criteria for MOD‑AD
- Have a history of relapsing MOG‑AD with at least one documented relapse over the last 12 months prior to randomization
- Have a documented positive serum MOG antibody test using a cell-based assay within 6 months prior to randomization
- Does not have a clinically relevant active infection (eg, sepsis, pneumonia)
- Does not have a history of chronic ongoing infections (eg, Hepatitis B or C, HIV, or tuberculosis)
If enrolled, participants will be asked to complete weekly study visits to receive subcutaneous infusions of the study drug for up to four years, or longer, depending on if they decide to participate in the extended open-label treatment period. If they experience a relapse while in the study, participation could be shorter.
During the first treatment period, participants will be randomized 1:1 to receive either the investigational drug or the placebo. In the open-label extension period, all participants will receive the investigational drug.
Please note that the Extended OLE Period referenced within this website is not offered to participants in countries where it’s possible to have access to rozanolixizumab through other means after the end of the cosMOG study’s main study period. In these countries, patients will have the opportunity to participate in the Main OLE Period only.
The cosMOG study timeline
During the study, participants will attend study visits.
Assessments may include:
- Blood samples
- Physical exams
- Electrocardiogram (ECG)
- Questionnaires
- Eye exams
- Side effects review
- Magnetic resonance imaging (MRI) scans
- Study drug administration
- Neurological exams
- Urine samples
- Vital Signs
Participants’ health may get better, get worse, or stay the same. The study team will discuss all known risks and benefits with potential participants before they agree to take part.
