IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT03474263|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Biological: Biologic: IC14 (monoclonal antibody against human CD14)||Phase 2|
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 Massachusetts General Hospital 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label Biomarkers-Driven Study Historical controls|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||April 12, 2020|
|Estimated Study Completion Date :||July 12, 2020|
Experimental: IC14 (monoclonal anti-CD14 antibody)
Biologic: IC14 (monoclonal anti-CD14 antibody) 4 mg/kg intravenously followed by IC14 2 mg/kg intravenously on Days 2-4. This four-day cycle will be repeated on Days 8-11.
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.
Other Name: Anti-CD14
- Glial Activation [ Time Frame: one month ]Glial activation measured in the motor region measured by [11C]-PBR28 positron emission tomography (PET). Studies have shown this marker localizes to areas of glial activation and correlates with disease progression and outcomes.
- Serum neurofilament [ Time Frame: one month ]Serum neurofilament is a biomarker that has been shown to correlate with ALS severity
- Urinary p75 neurotrophin receptor [ Time Frame: one month ]Urinary p75 neurotrophin receptor is a biomarker that has been shown to correlate with ALS severity
- Safety [ Time Frame: six weeks ]Adverse event reporting
- Immunogenicity [ Time Frame: six weeks ]Human anti-monoclonal antibodies
- Pharmacokinetics [ Time Frame: one month ]Peak Plasma Concentration (Cmax) of IC14
- Pharmacodynamics [ Time Frame: one month ]Monocyte CD14 saturation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474263
|Contact: Jan Agosti, MD||(206)email@example.com|
|United States, Massachusetts|
|Neurological Clinical Research Institute (NCRI)||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Nazem Atassi, MD, MMSc 617-643-6114 firstname.lastname@example.org|
|Principal Investigator:||Nazem Atassi, MD, MMSc||Massachusetts General Hospital|