drugset / Trial / NCT03508453

IC14 for Treatment of Amyotrophic Lateral Sclerosis

NCT03508453 ↗

Phase 2 Withdrawn Implicit Bioscience
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-08-15
Primary completion
2023-05-15
Completion
2023-12-15

Outcome

Outcome not reported

Stopped (Enrollment): “No participants enrolled in study”

Drugs

EvaluationDrugModalityDoseRoute
Comparator IC14 Monoclonal antibody 4 mg/kg Intravenous