NCT03474263

IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)

A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Implicit Bioscience · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Biologic: IC14 (monoclonal antibody against human CD14)	IC14 intravenous infusion daily for four days on two successive weeks then MR-PET Scan evaluation for impact on glial activation.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-04-12
• Completion: 2021-07-12
• First posted: 2018-03-22
• Last updated: 2020-06-24

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study