A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Part… (NCT04875975) | Clinical Trial Compass
TerminatedPhase 2
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
Stopped: The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.
United States12 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range18 Years – 89 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Study participant must be ≥18 to ≤89 years of age
* Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody
* Study participant must have ≥2 seizures/week during the Screening Period or have experienced such seizures that stopped following high dose corticosteroids (500 to 1000 milligram (mg) methylprednisolone (MP) equivalent/day):
* Either faciobrachial dystonic seizures (FBDS) with or without other focal (partial) seizures including focal to bilateral tonic clonic
* Or focal (partial) seizures including focal to bilateral tonic clonic and fulfil the following new-onset Autoimmune encephalitis (AIE) criteria
* Study participant has initiated or re-initiated corticosteroids at a dose of 500 to 1000 mg MP equivalent/day within 42 days prior to randomization. Participants re-initiating corticosteroids are eligible only if re-initiation is due to seizure rebound and within the timeframe outlined. If the study participant has initiated a steroid taper, the study participant cannot receive an oral steroid dose lower than 40mg/day when randomized
* Study participant with onset of disease symptom between 0 to 12 months prior to Screening, per investigator's assessment.
* Study participant weighs at least 35 kg at Screening
* 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)…
What they're measuring
1
Number of Seizure Free Study Participants at the End of the Treatment
Timeframe: From Baseline until the end of the Treatment (Week 25)