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IC14 for Treatment of Amyotrophic Lateral Sclerosis

NCT03508453 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-05

No results posted yet for this study

Summary

Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks. Blood and urine tests will be done to measure biomarkers in order to evaluate clinical response and to monitor for safety. Other evaluations include patient questionnaires about function, quality of life and mental function; pulmonary function test; and sniff nasal pressure.

Conditions

Interventions

BIOLOGICAL

IC14

Monoclonal antibody against CD14

OTHER

Placebo

sterile normal saline for injection prepared to be identical to study drug

Sponsors & Collaborators

  • Implicit Bioscience

    lead INDUSTRY

Principal Investigators

  • Robert D Henderson, MBBS · Royal Brisbane & Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2023-05-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508453 on ClinicalTrials.gov