Rozanolixizumab for Autoimmune Encephalitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called rozanolixizumab, an antibody therapy, for individuals with autoimmune encephalitis. This condition occurs when the immune system mistakenly attacks the brain, causing seizures and cognitive problems. The trial aims to determine if the treatment can reduce seizures and improve brain function while assessing its safety for participants. Some participants will receive the actual medication, while others will receive a placebo, an inactive substance, to compare results. This trial suits those who have experienced frequent seizures due to autoimmune encephalitis for up to a year and have been on specific steroid treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must have started or restarted corticosteroids recently, so you may need to continue those if applicable.
Is there any evidence suggesting that rozanolixizumab is likely to be safe for humans?
Research has shown that rozanolixizumab has been tested for various health conditions. It is approved in the United States for treating myasthenia gravis, a disease affecting muscles and nerves. In studies for myasthenia gravis, rozanolixizumab lowered certain antibodies with few serious side effects. Most participants did not experience major problems during treatment.
In other studies, the treatment was tested for autoimmune encephalitis, a condition affecting the brain. These studies evaluated both the treatment's effectiveness and safety. The treatment was generally well-tolerated, with most participants not experiencing severe reactions.
Overall, while some side effects may occur, serious problems have not been commonly reported. This suggests that rozanolixizumab is relatively safe based on previous research.12345Why do researchers think this study treatment might be promising for autoimmune encephalitis?
Rozanolixizumab is unique because it targets the neonatal Fc receptor (FcRn), which is different from most other treatments for autoimmune encephalitis that often involve corticosteroids or immune-suppressing drugs. By blocking FcRn, rozanolixizumab reduces harmful antibodies in the bloodstream without broadly suppressing the immune system. This specific mechanism of action could mean fewer side effects and a more targeted approach to treating the condition, which has researchers excited about its potential benefits.
What evidence suggests that rozanolixizumab might be an effective treatment for autoimmune encephalitis?
Research has shown that rozanolixizumab, which participants in this trial may receive, might help treat autoimmune diseases by lowering certain harmful antibodies called IgG autoantibodies, which cause inflammation. In earlier studies on myasthenia gravis, a disease that also involves these antibodies, rozanolixizumab reduced them by up to 78% and improved patient health. Although specific data for autoimmune encephalitis remains limited, the mechanism of rozanolixizumab suggests it could help manage symptoms like seizures. Rozanolixizumab already has approval for other autoimmune diseases, indicating its potential for treating autoimmune encephalitis.12356
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 2273 (UCB)
Are You a Good Fit for This Trial?
Adults aged 18-89 with LGI1 autoimmune encephalitis, weighing at least 35 kg, not pregnant or breastfeeding and using contraception can join. They must have frequent seizures or those controlled by high-dose steroids, and started treatment recently. Excluded are those with chronic infections, liver disease, positive TB test, organ transplants, hypersensitivity to study drugs or similar medications, recent live vaccinations, certain blood disorders or a history of cancer within the last five years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rozanolixizumab or placebo to assess efficacy, safety, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rozanolixizumab
Trial Overview
The trial is testing Rozanolixizumab's effectiveness in reducing seizures and improving cognitive function compared to a placebo. Participants will be randomly assigned to receive either the medication or placebo while monitoring seizure frequency and cognitive changes as well as safety and drug levels in the body.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive a predefined dose of rozanolixizumab.
Participants will be randomized to receive a dose of placebo.
Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Jean-Christophe Tellier
UCB Biopharma SRL
Chief Executive Officer since 2015
MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD
Dr. Iris Loew-Friedrich
UCB Biopharma SRL
Chief Medical Officer since 2014
MD from University of Leuven, PhD in Medical Sciences from University of Leuven
Citations
Rozanolixizumab (Rystiggo®)
Press Release 11 Apr 2025 Global data show real-world effectiveness of romosozumab for patients at high fracture risk.
NCT04875975 | A Study to Test the Efficacy, Safety, and ...
The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication ...
Rozanolixizumab: First Approval - PMC
Developed by UCB Pharma for the treatment of autoimmune diseases, rozanolixizumab received its first approval on 27 June 2023 for the treatment ...
Clinical Study Results
The study drug rozanolixizumab is designed to reduce the levels of the IgG autoantibodies that cause inflammation. Rozanolixizumab is already ...
Rozanolixizumab for Myasthenia Gravis - PubMed Central - NIH
Comparable Efficacy to PLEX: Clinical trials demonstrate up to a 78% reduction in IgG levels, with improvements in MG outcome measures (MG-ADL, ...
The First Randomized, Double-Blind, Placebo-Controlled ...
To evaluate efficacy and safety of rozanolixizumab for treatment of leucine-rich glioma inactivated 1 (LGI1) autoimmune encephalitis (AIE).
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