Rozanolixizumab in Participants with LGI1 Autoimmune Encephalitis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
IRAS ID
291127
Contact name
Julie Dalenga
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2019-004778-25
Duration of Study in the UK
2 years, 4 months, 19 days
Research summary
A study to determine the effectiveness and safety of rozanolixizumab (study drug) in participants with leucine-rich glioma inactivated 1 autoimmune encephalitis.
UCB is sponsoring a study which aims to assess the activity of rozanolixizumab (study drug) in adult participants with leucine-rich glioma inactivated 1 (LGI1) autoimmune encephalitis (AIE).
AIE is a group of disorders where the immune system causes inflammation of the brain, leading to debilitating neurological and psychiatric symptoms. There are currently no approved treatments for AIE.
Approximately 68 adult study participants with LGI1 AIE, with onset of disease between 0 to 12 months prior to study entry, will be randomised.
The maximum study duration per study participant is 34 weeks. There are 3 study periods:
• Screening Period – to determine whether patients are eligible to take part in the study.
• Treatment Period – participants who have been confirmed eligible for the study will receive rozanolixizumab or placebo (control) depending on which treatment they are assigned to.
• Safety Follow-Up (SFU) Period – participants who complete the 24-week Treatment Period or stop taking the study drug/placebo early, as well as study participants who receive rescue medication during the 24-week Treatment Period, will undergo the End of Treatment Visit (EOT) / Early Discontinuation Visit and enter the SFU Period.LAY SUMMARY OF STUDY RESULTS:
We are working on it and the final summary will be available early April 2025.
Protocol and SAP will be made public on CTgov during the results posting in Q1 2025.REC name
London - South East Research Ethics Committee
REC reference
21/FT/0040
Date of REC Opinion
17 May 2021
REC opinion
Further Information Favourable Opinion