IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)

Status Withdrawn

Clinical Trial Summary

Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. This scan will measure areas of ALS disease activity and assess response to IC14 treatment. MR-PET scans will be compared to historical controls.

Clinical Trial Description

This is an open-label, biomarkers-driven study.

Patients with rapidly progressive ALS will be assigned to the following dose regimen of IC14:

• 4 mg/kg intravenously on Day 1, followed by 2 mg/kg daily x 3 days on Days 2-4. This 4-day course will be repeated on Days 8-11.

Patients will be followed for 28 days after the last dose of study drug. Patients will all undergo [11C]-PBR28-MR-PET scans at two time points: before treatment onset and after the last treatment cycle.

Patients will be followed for 28 days after the last dose of study drug for safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03474263
Study type	Interventional
Source	Implicit Bioscience
Contact
Status	Withdrawn
Phase	Phase 2
Start date	September 1, 2019
Completion date	July 12, 2021

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