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Monoclonal Antibodies

Rozanolixizumab for Autoimmune Encephalitis

Phase 2
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until the end of study visit (week 32)
Awards & highlights

Study Summary

This trial will test if the drug rozanolixizumab is effective in reducing seizures, cognitive decline, and the need for rescue medication, as well as being safe and tolerable.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing Rozanolixizumab's effectiveness in reducing seizures and improving cognitive function compared to a placebo. Participants will be randomly assigned to receive either the medication or placebo while monitoring seizure frequency and cognitive changes as well as safety and drug levels in the body.See study design
What are the potential side effects?
Potential side effects of Rozanolixizumab may include reactions related to immune system suppression such as increased risk of infection. Specific side effects are not listed but would typically relate to how the drug affects the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tested positive for the LGI1 antibody.
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I started or restarted corticosteroids at a specific dose within the last 42 days.
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I have more than 2 seizures a week or they stopped with high dose steroids.
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I weigh at least 35 kg.
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I am not pregnant, not breastfeeding, and will follow contraceptive advice.
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I am between 18 and 89 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until the end of study visit (week 32)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until the end of study visit (week 32) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of seizure free study participants at the end of the Treatment Period
Secondary outcome measures
Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment Period
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period
+2 more

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965
29%
Headache
17%
Diarrhoea
12%
Blood immunoglobulin G decreased
12%
Nausea
10%
Vomiting
10%
Nasopharyngitis
10%
Rash
7%
Back pain
7%
Pyrexia
5%
Abdominal pain
5%
Urinary tract infection
5%
Hypogammaglobulinaemia
2%
Pericarditis
2%
Myasthenia gravis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rozanolixizumab ~10 mg/kg
Rozanolixizumab ~7 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RozanolixizumabExperimental Treatment1 Intervention
Participants will be randomized to receive a predefined dose of rozanolixizumab.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive a dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rozanolixizumab
2019
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,424 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,951 Total Patients Enrolled

Media Library

Rozanolixizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04875975 — Phase 2
Autoimmune Encephalitis Research Study Groups: Rozanolixizumab, Placebo
Autoimmune Encephalitis Clinical Trial 2023: Rozanolixizumab Highlights & Side Effects. Trial Name: NCT04875975 — Phase 2
Rozanolixizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875975 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research endeavor been undertaken before?

"As of now, 4 clinical trials of Rozanolixizumab are being conducted in 26 countries across 21 cities. First initiated by UCB Biopharma SRL back in 2020, the initial trial consisted of 43 participants and successfully completed its Phase 3 approval stage. Since then, 18323 additional studies have been performed."

Answered by AI

Are there other investigations showcasing the efficacy of Rozanolixizumab?

"Currently, there are 4 clinical trials researching Rozanolixizumab with 3 in the pivotal Phase 3 stage. Although a few of these studies occur in Tbilsi, Texas, this medication is under investigation at 188 distinct locations worldwide."

Answered by AI

Is enrollment for this research project still open?

"Presently, 68 individuals with encephalitis aged between 18 and 89 are being enrolled in this trial. To be qualified for the study, candidates must exhibit faciobrachial dystonic seizures (FBDS) or other focal partial convulsions that include tonic-clonic activity; they should have begun IVMP treatment at a dose of 500 to 1000 mg/day within 14 days preceding randomization but cannot be receiving an oral steroid dosage lower than 60mg/day when randomized; their condition's onset must occur between 0 to 12 months before screening; participants ought to weigh no less than 35 kg during screening, not"

Answered by AI

How many venues are participating in the management of this research?

"This clinical trial is taking place in 6 different facilities, the most notable of which are located at Aie001 50304 in Dallas, Texas; Aie001 50101 in Aurora, Colorado; and Aie001 50243 in Boston."

Answered by AI

Has the FDA given its stamp of approval to Rozanolixizumab?

"The safety of Rozanolixizumab is rated at a 2 due to its phase 2 trial status, indicating that while there has been some research on the drug's safety, none exists regarding efficacy."

Answered by AI

Does this clinical trial accept participants of advanced age?

"The ages of those allowed to partake in this research venture range from 18 years old to the more senior age bracket of 89."

Answered by AI

How many individuals have joined the current experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is still recruiting volunteers that meet its criteria. This study was posted on September 27th 2021 and has since been amended as recently as November 24 2022; 68 participants are necessary across 4 different sites in total."

Answered by AI

Are there currently vacancies for participants in this clinical research?

"Affirmative. Clinicaltrials.gov documents that this medical experiment, which initially launched on September 27th 2021, is currently recruiting participants. 68 individuals will be admitted from 4 distinct trial locations."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
2021. "A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04875975.
All > Autoimmune Hemolytic Anemia
~3 spots leftby Feb 2025
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