Rozanolixizumab for Autoimmune Encephalitis
Trial Summary
What is the purpose of this trial?
This trial is testing rozanolixizumab, a medication that may help people with seizures by calming their immune system. It focuses on those who do not respond well to other treatments.
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.
How does the drug Rozanolixizumab differ from other treatments for autoimmune encephalitis?
Rozanolixizumab is unique because it targets the neonatal Fc receptor (FcRn), which is involved in the recycling of antibodies, potentially reducing harmful antibodies in autoimmune conditions. This mechanism is different from other treatments like rituximab or tocilizumab, which target specific immune cells or cytokines.12345
Research Team
UCB Cares
Principal Investigator
001 844 599 2273 (UCB)
Eligibility Criteria
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
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
Treatment Details
Interventions
- Rozanolixizumab
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