NCT04875975

A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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, onset of seizure freedom and to assess safety and tolerability.

Conditions

• Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Interventions

Type	Name	Description
DRUG	Rozanolixizumab	* Pharmaceutical form: Solution for infusion * Route of administration: Subcutaneous use Subjects will receive rozanolixizumab in a pre-specified sequence during the Treatment Period.
DRUG	Placebo	* Pharmaceutical form: Solution for infusion * Route of administration: Subcutaneous use Subjects will receive placebo in a pre-specified sequence during the Treatment Period.

Timeline

• Start date: 2021-09-27
• Primary completion: 2024-03-08
• Completion: 2024-04-26
• First posted: 2021-05-06
• Last updated: 2025-05-31
• Results posted: 2025-05-31

Locations

27 sites across 9 countries: United States, Australia, Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study