Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04309604
Brief Summary:
The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Detailed Description:
Manipulation of immune-driven inflammatory responses may have therapeutic utility in amyotrophic lateral sclerosis (ALS) and recent data suggest that ALS may respond to peripheral intervention by expanding Tregs in mice and humans. The approach with IC14 builds on this hypothesis by targeting CD14 as a master regulator of the immune response of peripheral cell populations, which in turn determines the activation status and phenotype of peripheral T cells that enter the central nervous system (CNS) and drive further microglia activation .Binding and blocking membrane CD14 (mCD14) on peripheral immune cell populations with IC14 may thus be a relevant therapeutic target in ALS.
IC14 has been safe, well tolerated and had no serious adverse events related to study drug.
This is a protocol for 12 weeks of the investigational medication IC14 for 6 participants. An extension for 6 additional doses every 2 weeks will be done if the drug is safe and well tolerated. Up to 20 subjects may be screened in order to identify eligible subjects that meet all inclusion and exclusion criteria.
At the screening visit, the Principal Investigator will review the study procedures and consent form with the participant. After obtaining informed consent, the participant will receive IC14 8 mg/kg intravenously every two weeks (± 7 days) for 6 doses (12 weeks). An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated. A second extension for 14 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Study:
NCT04309604
Study Brief:
Protocol Section:
NCT04309604