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.

cosMOG will work to find out if the investigational drug can prolong the time between relapses of inflammation in people with MOG‑AD.

We are looking for about 100 people worldwide who (among other criteria):

  • Are between 18 and 89 years old
  • Have relapsing MOG‑AD with at least one relapse in the last 12 months
  • Have at least one of the following:
    • Optic neuritis
    • Transverse myelitis
    • Acute disseminated encephalomyelitis (ADEM) or MOG‑AD encephalitis
  • 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. 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.

All participants will receive the investigational drug in the open-label extension period.

The cosMOG study timeline

SCREENING PERIOD

2 Visits

Various tests and assessments will be done, including physical, neurological, and eye exams and MRI scans.

DOUBLE-BLIND TREATMENT PERIOD

Up to 2.5 Years

Participants will be randomly assigned to receive weekly subcutaneous infusions of either the investigational drug or the placebo.

OPEN-LABEL EXTENSION PERIOD

About 1 Year

All participants will receive weekly subcutaneous infusions of the investigational drug.

FOLLOW-UP PERIOD

1 Visit

Participants will be asked to go to the study clinic about two months after they receive their last dose of the investigational drug for a final health check.

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

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.

Do you have a patient who may be interested in cosMOG?

If you know a patient who may be interested and is potentially eligible to participate in the study, please share this website with them.

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