A Continuation Study of Latozinemab in Participants with Neurodegenerative Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alector LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

25 Sep 2024 → 7 Jan 2026

Decision date (initial)

2025-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-506805-20-01

ClinicalTrials.gov

NCT06111014

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

To provide continued access to latozinemab for participants who have previously participated in a latozinemab study sponsored by Alector, or in partnership or collaboration with Alector.

Secondary objectives 2

1. To monitor the safety and tolerability of latozinemab measured by safety assessments and anti-drug antibodies (ADAs).
2. To monitor the clinical benefit of ongoing treatment with latozinemab for participants using clinical outcome assessments (COAs).

Conditions and MedDRA coding

Neurodegenerative Diseases

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002997-PIP01-21

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Has provided informed consent for this study. Participants unable to provide consent on their own behalf are not eligible.
2. Has successfully completed participation in their previous latozinemab study (e.g., AL001-2 or AL001-3).
3. At the first visit, women must be nonpregnant and nonlactating, and one of the following conditions must apply: a. Not a woman of childbearing potential b. Is a woman of childbearing potential and agrees to use a highly effective contraceptive method from the first visit until 10 weeks after the last dose of study treatment. c. Women of childbearing potential must have a serum or urine pregnancy test conducted at the Transition Visit.
4. Men must agree to use acceptable contraception and not donate sperm from the first visit until 10 weeks after the last dose of study treatment.
5. Agrees not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study treatment.
6. Willing to and can comply with the study protocol requirements, in the opinion of the investigator.

Exclusion criteria 6

1. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
2. Significant kidney disease.
3. Impaired liver function.
4. Clinically significant blood abnormalities.
5. Presence of an abnormal ECG that is clinically significant.
6. Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the participant’s well-being or safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of participants receiving latozinemab
2. Duration of treatment

Secondary endpoints 4

1. Number, percentages, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
2. Number and percentage of cases of the development of ADAs to latozinemab
3. Actual values of the CGI-S every 3 months
4. Actual values of the CGI-I every 3 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alector LLC

Sponsor organisation

Alector LLC

Address

131 Oyster Point Boulevard

City

South San Francisco

Postcode

94080-2029

Country

United States

Scientific contact point

Organisation

Alector LLC

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Alector LLC

Contact name

Clinical Trial Information Desk

Third parties 4

Locations

7 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 59 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications