Latozinemab Continuation for Neurodegenerative Disease

Recruiting at 22 trial locations

Overseen By Helene Favre

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alector Inc.

Must be taking: Latozinemab

Disqualifiers: Heart disease, Liver disease, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: Up to 190 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for Latozinemab or similar treatments?

The research does not provide specific safety data for Latozinemab, but it highlights that new therapeutic biologics often have safety-related updates to their labels, indicating ongoing safety monitoring is important. ^{1 2 3 4 5}

How does the drug Latozinemab differ from other treatments for neurodegenerative diseases?

Latozinemab is unique because it is an immunotherapy that targets specific proteins involved in neurodegenerative diseases, similar to ABBV-0805, which targets aggregated α-synuclein in Parkinson's disease. This approach is different from traditional treatments as it aims to modify the disease process by reducing toxic protein aggregates rather than just alleviating symptoms. ^{6 7 8 9 10}

Research Team

Study Lead

Principal Investigator

Alector Inc.

Eligibility Criteria

This trial is for people who have already been in a Latozinemab study. They must be able to give consent, not pregnant or breastfeeding, and willing to use contraception. People with severe allergies to certain proteins, significant heart, liver or kidney disease, brain diseases other than FTD, or those on immunosuppressive therapy can't join.

Inclusion Criteria

Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker)

You have finished taking part in the previous Latozinemab study.

I am not pregnant or breastfeeding.

Exclusion Criteria

Use of any experimental vaccine or gene therapy

You have had serious allergic reactions to certain types of medications made from proteins.

I do not have serious heart, liver, or kidney disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label latozinemab at a dose of 60 mg/kg every 4 weeks

Up to 190 weeks

Visits every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Latozinemab

Trial Overview The trial provides continued access to Latozinemab for participants from previous studies of the drug. It's designed to see if ongoing treatment remains safe and effective over a longer period.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w

Who Is Running the Clinical Trial?

Alector Inc.

Lead Sponsor

Trials

11

Recruited

1,300+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Rituximab (RTX) has a relatively low incidence of adverse events (AEs) in patients with neuromyelitis optica spectrum disorder (NMOSD), with 28.57% of patients experiencing any AEs, and most being mild to moderate in severity.

Compared to other immunosuppressants like azathioprine and mycophenolate mofetil, RTX appears to be safer, making it a recommended first-line treatment for NMOSD due to its favorable safety profile and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of rituximab in neuromyelitis optica spectrum disorder: a systematic review and meta-analysis. Wang, H., Zhou, J., Li, Y., et al.[2022]

A review of 31 immunomodulatory drugs approved between 1998 and 2017 revealed 372 postmarketing safety-related label modifications, indicating that safety issues are often identified after a drug is on the market, with a median duration of 5 years before these issues are recognized.

The most common safety concerns were related to infections and immunologic phenomena, and drugs approved through expedited pathways had more safety issues compared to those approved through regular processes, highlighting the need for ongoing monitoring of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty Years of Targeted and Biologic Immunomodulatory Drugs: Postmarketing Modifications of Drug Labels Approved by the US Food and Drug Administration. Berman, J., Yavne, Y., Edel, Y., et al.[2022]

In a study of 1000 patients with multiple sclerosis (MS) and related disorders treated with rituximab, the rates of serious safety events (SSEs) such as infections and lymphopenia were found to be relatively low, with specific incidence rates per 1000 person-years for lymphopenia at 19.2 and infections at 38.6.

Risk factors for infections included longer duration of therapy, male gender, increased disability, and prior immunosuppression, highlighting the importance of careful monitoring and risk assessment in patients undergoing B-cell depleting therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious safety events in rituximab-treated multiple sclerosis and related disorders. Vollmer, BL., Wallach, AI., Corboy, JR., et al.[2021]

In a study of 497 elderly patients with inflammatory bowel disease, those treated with vedolizumab (VDZ) had a lower incidence of mild infections (93.1 per 1000 patient-years) compared to those on 5-aminosalicylic acid (5-ASA) and chronic steroids, suggesting a potentially safer profile for VDZ.

The incidence of malignancies was similar between the VDZ and 5-ASA groups (17.6 vs. 15.6 per 1000 patient-years), while the steroid group had a higher incidence (42.6 per 1000 patient-years), indicating that VDZ may be a safer option for elderly patients with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Infections and Malignancy Among Elderly Male Patients with IBD Exposed to Vedolizumab, Prednisone, and 5-ASA Medications: A Nationwide Retrospective Cohort Study. Khan, N., Pernes, T., Weiss, A., et al.[2021]

In a phase 2 trial involving 431 patients with mild to moderate Alzheimer's disease, crenezumab did not meet the primary efficacy endpoints for improving cognitive function over 68 weeks, indicating it may not significantly enhance cognition or function overall.

However, an exploratory analysis suggested that high-dose crenezumab may reduce cognitive decline in patients with milder forms of Alzheimer's, particularly those with Mini-Mental State Examination scores of 22 to 26, warranting further investigation into higher doses for early-stage patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ABBY: A phase 2 randomized trial of crenezumab in mild to moderate Alzheimer disease. Cummings, JL., Cohen, S., van Dyck, CH., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Adverse events of rituximab in neuromyelitis optica spectrum disorder: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Twenty Years of Targeted and Biologic Immunomodulatory Drugs: Postmarketing Modifications of Drug Labels Approved by the US Food and Drug Administration. [2022]

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

Serious safety events in rituximab-treated multiple sclerosis and related disorders. [2021]

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

Incidence of Infections and Malignancy Among Elderly Male Patients with IBD Exposed to Vedolizumab, Prednisone, and 5-ASA Medications: A Nationwide Retrospective Cohort Study. [2021]

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

Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities. [2022]

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

ABBV-0805, a novel antibody selective for soluble aggregated α-synuclein, prolongs lifespan and prevents buildup of α-synuclein pathology in mouse models of Parkinson's disease. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dale Schenk One Year Anniversary: Fighting to Preserve the Memories. [2019]

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

Internalized antibodies to the Abeta domain of APP reduce neuronal Abeta and protect against synaptic alterations. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Active Immunotherapy Targeting α-Synuclein with PD03A in Patients with Early Parkinson's Disease: A Randomized, Placebo-Controlled, Phase 1 Study. [2022]

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

ABBY: A phase 2 randomized trial of crenezumab in mild to moderate Alzheimer disease. [2022]