The first ever MOG Antibody Disease phase 3 clinical trial is now taking place. A new drug called Rozanolixizumab will be trialed with MOG Antibody Disease patients as a preventative treatment. If successful, this treatment will be the first-ever FDA-approved treatment for MOGAD and could be used as a preventive treatment to stop relapses.
What is Rozanolixizumab?
Rozanolixizumab, also referred to as Rozimab, is a monoclonal antibody that blocks the activity of the FcRN molecule, which usually preserves antibodies in the bloodstream from being destroyed. 1
Rozimab is currently undergoing testing on patients with conditions involving an autoimmune response, specifically Myasthenia Gravis and Primary Immune Thrombocytopenia. But now, the first clinical trial to test it on MOG Antibody Disease patients has just started. 1
How does Rozanolixizumab work?
Rozanolixizumab is a drug that blocks the activity of the FcRN molecule, which usually preserves antibodies in the bloodstream from being recycled. This molecule is found on blood vessel walls which routinely scoop up plasma to clean it. The FcRN molecule holds antibodies to prevent them from being degraded in the cleaning process. 2
Image showing antibodies being held in bloodstream by FcRN molecules.3
Blocking FcRN causes antibodies in the blood to get degraded quickly, dropping the patients' antibodies by 70% in a day, similar to plasma exchange. This treatment is to be repeated weekly after antibody levels naturally recover. 2
Image showing FcRN molecules being blocked, causing antibodies to be recycled.3
Because autoantibodies like MOG are found in low frequency in the blood, this drug will hopefully deplete autoantibodies. The depletion of antibodies includes all antibodies, not just MOG, and will have a quieting effect on the immune system. 2
The treatment is 4 millilitres in volume. The maximal volume for a usual subcutaneous shot is 1.5 millilitres. Therefore, Rozimab has to be administered as a subcutaneous infusion over 15 minutes. A patch with a needle is placed on the skin and connected to a pump with the treatment. 2
What is the clinical trial doing, and how does it work?
The trial aims to see whether Rozanolixizumab prevents relapses in MOG Antibody Disease. 2 This trial is also the first phase 3 clinical trial for MOGAD. Phase 3 is the last testing phase to see if it is a safe, beneficial, and effective treatment.4
The trial is a randomised trial with a placebo arm, meaning half of the patients will get Rozanolixizumab, and the trial staff will give the others an infusion with no effect. But patients do not know which one they have been given. 4
The trial will take place in 50 sites across 20 countries worldwide and aims to enrol 104 patients by the end of the study. Recruitment started in December 2021 and is still ongoing.4
Clinical Trail Information
Who can take part in the clinical trial?
To take part in this clinical trial, a participant must meet the criteria below: 4
- Aged between 18 and 89 years.
- MOG Presentation of Optic Neuritis, Transverse Myelitis, Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis, or a combination of these presentations.
- Test positive for MOGAD antibodies using cell-based assay at screening.
- Participants must have a history of relapsing MOGAD with at least one documented relapse over the last 12 months before randomisation.
- Participants must be clinically stable during the screening visit and screening period.
What are the Exclusion Criteria?
Participants must also not meet the exclusion criteria for the trial: 4
- Diagnosed with Multiple Sclerosis, AQP4 Positive NMOSD, or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant.
- Participant has a clinically relevant infection (e.g sepsis, pneumonia, or abscess).
- Participant has a serious infection (resulting in hospitalisation or requiring parental antibiotic treatment) within six weeks before the first dose of the Treatment.
- Test positive for AQP4 antibodies at screening.
- Participants must also have not taken Rituximab in the last six months. Participants must have been off it for at least six months and have their B cell levels back to normal before the screening.
Where is the clinical trial taking place?
At the time of writing, there are currently 31 sites conducting the trial in 13 countries: 4
- 6 sites in the USA (Scottsdale - Arizona, Palo Alto - California, Aurora - Colorado, Peoria - Illinois, Kansas City - Kansas, and Boston - Massachusetts)
- 11 sites in Europe (Gent - Belgium, Hradec Kralove - Czech Republic, Bron Cedex, Caen & Strasbourg - France, Berlin & Gottingen - Germany, Verona - Italy, Barcelona & Madrid - Spain, Bern - Switzerland)
- 12 sites in Asia -
- 8 sites in Japan (Bunkyo-Ku, Chiba-Shi, Kodaira, Koriyama, Sendai x2, Shinjuku-Ku and Suita)
- 2 sites in the Republic of Korea (Goyang-si and Seoul)
- 2 sites in Turkey (Istanbul & Samsun)
- 1 site in Mexico and 1 site in Australia
In the future, more sites could become available.5
What happens if a patient relapses in the trial?
The trial is designed to prevent relapses but uses a placebo arm which could cause relapses as some participants would not be on any preventive treatment. However, patients are only allowed to have one relapse in the study.5
Once confirmed as a relapse, they will be treated to stop the attack, usually with steroids or IVIG, but it is site-specific.5
After being treated, the participant is guaranteed Rozanolixizumab until the end of the study if they want to continue. The participant won't know whether they were in the placebo or the treatment arm, but from then on, they will be using Rozimab.5
If you do not relapse, Rozanolixizumab seems to work, and everything looks good; you should be able to continue using it. In that case, all participants can receive the treatment (if they wish).5
How long will the trial last?
The trial duration is expected to take three and a half years in total so that we can expect the results in 2025. 2
Where can I sign up to the trial & find more information about it?
To sign up or find out more information about the Rozanolixizumab trial in MOG Antibody Disease you can read the clinical trial information page.
Conclusion
In this post, we learned about Rozanolixizumab, how it works, and the clinical trial to see if it is a safe and effective treatment for MOG Antibody Disease.
Subscribe to the MyMyelitis email list, and you will be the first to know when the trial results are released. Also, you will receive information on other clinical trials involving MOG Antibody Disease that are taking place.
1. Myasthenia Gravis News. Rozanolixizumab (UCB7665). Myasthenia Gravis News. https://myastheniagravisnews.com/rozanolixizumab-ucb7665/. Published 2022. Accessed March 22, 2022.
2. Levy M. CosMOG: Anti-FcRn Agent Rozanolixizumab for Relapse Prevention in MOGAD. VJNeurology; 2022. https://www.youtube.com/watch?v=MlQn4-IEYJA.
3. A M. FcRn Inhibitors to Treat Autoimmune Conditions. 2020. https://www.driehaus.com/perspectives/fcrn-inhibitors-to-treat-autoimmune-conditions.
4. A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD) (cosMOG). https://clinicaltrials.gov/ct2/show/NCT05063162?cond=Rozanolixizumab&draw=3&rank=11. Published 2021. Accessed March 22, 2022.
5. Levy M, Lefelar J. The Latest From The MOG Initiative. The MOG Project; 2021. https://youtu.be/OafxpUB6eas.
