An Efficacy and Safety Study of Ravulizumab in ALS Participants

NCT04248465 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2023-01-10

Study results available
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Summary

The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

Conditions

Interventions

DRUG

Placebo

Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.

BIOLOGICAL

Ravulizumab

Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2021-10-17
Completion
2021-10-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT04248465 on ClinicalTrials.gov