Rozanolixizumab for Autoimmune Encephalitis

Recruiting at 33 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UCB Biopharma SRL

Must be taking: Corticosteroids

Must not be taking: Anti-neonatal FcRn

Disqualifiers: Epilepsy, Neoplastic disease, Renal impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 25 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing rozanolixizumab, a medication that may help people with seizures by calming their immune system. It focuses on those who do not respond well to other treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants must have started or restarted corticosteroids recently, so you may need to continue those if applicable.

How does the drug Rozanolixizumab differ from other treatments for autoimmune encephalitis?

Rozanolixizumab is unique because it targets the neonatal Fc receptor (FcRn), which is involved in the recycling of antibodies, potentially reducing harmful antibodies in autoimmune conditions. This mechanism is different from other treatments like rituximab or tocilizumab, which target specific immune cells or cytokines. ^{1 2 3 4 5}

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

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.

Inclusion Criteria

I have tested positive for the LGI1 antibody.

I started or restarted corticosteroids at a specific dose within the last 42 days.

I have more than 2 seizures a week or they stopped with high dose steroids.

Exclusion Criteria

I have had my spleen removed.

I have not received a live vaccine in the last 4 weeks and do not plan to during or within 8 weeks after the study.

I am allergic to the study medication or similar drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rozanolixizumab or placebo to assess efficacy, safety, and pharmacokinetics

25 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Treatment Details

Interventions

• Rozanolixizumab

Trial Overview 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.

Participant Groups

Group I: Rozanolixizumab Experimental Treatment 1 Intervention

Participants will be randomized to receive a predefined dose of rozanolixizumab.

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive a dose of placebo.

Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Approved in European Union as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Approved in Japan as Rystiggo for:

• Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

References

1. United States pubmed.ncbi.nlm.nih.gov

Tocilizumab in Autoimmune Encephalitis Refractory to Rituximab: An Institutional Cohort Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Rituximab in Rasmussen's encephalitis: A single center experience and review of the literature. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term remission with rituximab in refractory leucine-rich glioma inactivated 1 antibody encephalitis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Synergistic effect of rituximab with anti-epileptic drugs in treating sero-negative limbic encephalitis: a case report. [2021]

5. Sweden pubmed.ncbi.nlm.nih.gov

Long-term effect of rituximab in a case with late-onset Rasmussen´s encephalitis with anti-ganglioside IgGQ1b and anti-GAD antibodies positivity. Case Report. [2017]