Current studies | UCB
UCB's Global Corporate Website


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

Brief summary

The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, onset of seizure freedom, change in cognitive function, use of rescue medication and to assess safety and tolerability.

Medical Condition

Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

Min. Age


Max. Age


Who Can Join?



Inclusion criteria

-Study participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent -Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody measured by LGI1 serum autoantibody cell-binding assay -Study participant must have faciobrachial dystonic seizures (FBDS) and/or other partial [focal] seizures with or without secondary generalization (≥2 seizures/week) during the Screening Period, or have experienced such seizures that stopped as a result of intravenous methylprednisolone (IVMP) initiation -Study participant is currently considered for treatment with IVMP by the investigator or has initiated IVMP treatment at a dose of 500 to 1000 mg/day within 14 days prior to randomization. If the study participant has initiated a steroid taper, the study participant cannot be receiving an oral steroid dose lower than 60 mg/day when randomized -Study participant with onset of disease between 0 to 12 months prior to Screening -Study participant weighs at least 35 kg (for males and females) at Screening −A male participant must agree to use contraception during the treatment period and for at least 90 days after the final dose of study treatment and refrain from donating sperm during this period −A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of study treatment

Exclusion criteria

-Study participant has a known hypersensitivity to any components of the study medication or any other anti-neonatal Fc receptor (FcRn) medications. This includes a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation -Study participant has a confirmed prior diagnosis of epilepsy that is unrelated to LGI1 autoimmune encephalitis (AIE) -Study participant has active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix which has been definitively treated with standard of care approaches) -Study participant has 12-lead electrocardiogram (ECG) with findings considered clinically significant upon medical review -Study participant has current unstable liver or biliary disease, per investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis -Study participant has positive tuberculosis (TB) test at the Screening Visit -Study participant has any of the following active gastrointestinal (GI) disorders: inflammatory bowel disease, GI ulceration, or diverticulitis -Study participant has a history of solid organ transplant or hematopoietic stem cell transplant -Study participant has undergone a splenectomy -Study participant has a current or medical history of primary immune deficiency -Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies -Study participant has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of investigational medicinal product (IMP) -Study participant has previously received rozanolixizumab drug product -Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) are >2x upper limit of normal (ULN) -Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %) -Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) -For randomized study participants with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin but <1.5xULN, a Baseline diagnosis and/or the cause of any clinically meaningful elevation will have to be understood and recorded in the electronic case report form (eCRF) -If study participant has >ULN for ALT, AST, or ALP that does not meet the exclusion limit at Screening, the tests should be repeated, if possible, prior to dosing to ensure there was no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the study participants will have to be discussed with the medical monitor -Tests that result in ALT, AST, or ALP up to 25 % above the exclusion limit (>2xULN) will have to be repeated once for confirmation. This includes rescreening -Study participant has an IgG level ≤5.5 g/L at the Screening Visit -Study participant has absolute neutrophil count <1500 cells/mm^3 at the Screening Visit -Participant has QT interval corrected for heart rate using Fridericia’s formula (QTcF) >450 msec (for male participants) or QTcF >470 msec (for female participants) or QTcF >480 msec in participants with bundle branch block

Study Medication Description

Study Medication:


Other Descriptive Name:






Study Dates

September 2021

Actual Start Date of Enrollment

November 2023

Planned Study Completion Date

General Information

Study ID:
EudraCT Number:
2019-004778-25 Number:
Phase 2

Interested in enrolling in our study?

Just contact us

+43 (0) 1 291 80 08
0800-296176 (freephone)

+32 2 559 92 00
0800 38 008 (freephone)


Czech Republic
+420 221 773 442
800 144 395 (freephone)

+45 32462480
80 253827 (freephone)

+358 942733300
0800 9 13353 (freephone)

+33 1 47 29 45 55
0 805 222 949 (freephone)


+30 21 0997 4200
0080 012 9910 (freephone)

+36 1 472 5060
06 80 021 486 (freephone)

+353 1 463 2371
1800 93 00 75 (freephone)

+39 02 3007 9300
8009-86932 (freephone)

+32 2 559 92 12
8002 3204 (freephone)

+45 32462482
800-10101 (freephone)

+48 22 596 97 97
00 800 121 68 25 (freephone)

+351 213 025 300
800-8-56033 (freephone)


+4021 300 19 07

+421 2 592 020 23
0800 002 566 (freephone)

+34 915 70 06 49
8000-99684 (freephone)

+45 32462481
0200 898 671 (freephone)


+41 58 822 3180

The Netherlands
+31 76 573 1130
0800 3434335 (freephone)

+44 1753 777 100
0800 279 3177 (freephone)