Study Spotlight: CosMOG Clinical Trial
By Hannah Kelly In an April episode of our “Ask the Expert” podcast, Krissy Dilger of SRNA and Dr. Michael Levy, a neuroimmunology clinician and researcher at Massachusetts General Hospital, discussed the ongoing international clinical trial “CosMOG.” During this conversation, Dr. Levy explains what MOG antibody disease (MOGAD) is and provides an overview of CosMOG, an ongoing clinical trial of rozanolixizumab for MOGAD treatment. In this blog, we’re diving further into the details about rozanolixizumab and its side effects, the trial design, inclusion criteria, and how to participate. The inspiration behind studying rozanolixizumab for treatment of MOGAD came from evidence demonstrating a strong benefit of IVIG as a treatment for those with MOGAD. However, IVIG has several side effects and limitations, including blood clots, aseptic meningitis (inflammation of the covering of the brain and spinal cord, without a bacterial infection), and the need for multiple infusions per month. Rozanolixizumab and IVIG have a similar mechanism of action, but Rozanolixizumab “takes a shortcut” getting there according to Dr. Levy. This investigational drug is an antibody that targets FcRn, a protein on blood vessel walls that prevents the destruction of other proteins such as antibodies. By blocking FcRn, Rozanolixizumab allows the degradation of the body’s antibodies, including harmful antibodies like the MOG antibody. Over time, the body makes new antibodies, and the first to be produced are the “good ones” that are not harmful. Other drugs targeting FcRn showed success in treating other diseases where IVIG is also used as a therapy, and Rozanolixizumab itself was recently approved by the FDA to treat myasthenia gravis. The main goal of the CosMOG clinical trial is to determine if Rozanolixizumab can delay or prevent relapses in MOGAD. The trial is placebo-controlled, meaning participants have a 50-50 chance of either receiving the drug or not receiving it. The trial is also double-blinded, meaning both the participants and the study investigators do not know who gets the drug or the placebo. It is important to note that the trial does not assess if Rozanolixizumab can fix damage already done to the spinal cord or optic nerves from previous MOGAD attacks. Regarding safety, trials of Rozanolixizumab in myasthenia gravis demonstrated side effects such as aseptic meningitis and hypersensitivity reactions causing rash and swelling. At the time of the podcast, CosMOG had one case of aseptic meningitis; however, strategies such as giving Tylenol or Benadryl prior to administering the drug and adjusting drug dose according to body weight will hopefully lower the risk of this side effect. Because the trial aims to slow or stop relapses, it enrolls only relapsing MOGAD patients, or those who have had more than one attack, including one attack in the past year. If a study participant develops an attack during the study, they will automatically move from the placebo arm to the Rozanolixizumab arm, assuming this investigational drug proves safe and effective. Other inclusion criteria include being over the age of 18 and not taking other immunotherapies, including steroids, rituximab, or CellCept. The drug itself is infused weekly under the skin using a small needle for about 15 minutes at a study site. Eventually, participants may have the opportunity to receive infusions at home from a nurse. Given the logistics of study visits to receive the drug, it is recommended to check the map of trial sites and determine the feasibility of participating. The podcast audio, video, and transcript are available in our Resource Library. For more information about the trial, please reach out to your physician and/or check out the following websites:
The CosMOG clinical trial is expected to run through 2025. Though no results are available to report yet, after trial completion, the results will become unblinded, and a statistician will assess if the drug clearly and significantly prevents relapses compared to the placebo. If the drug proves to be effective, regulatory agencies will begin the process of drug approval before it hits the market.
