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- A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)
Clinical Trial
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)
The purpose of this study is to see if the investigational drug, pegcetacoplan (also known as APL-2), can slow the progression of ALS. Investigational means that pegcetacoplan is still being tested for safety and effectiveness but is not yet approved by any regulatory authorities (such as the United States Food and Drug Administration or the European Medicines Agency) for general use. The study will also evaluate how the body processes pegcetacoplan and how well it is tolerated.
Eligibility Criteria
- Inclusion Criteria: ALS symptom onset of is within 72 weeks prior Screening ALSFRS-R score of greater than or equal to 30 at screening Exclusion Criteria: Starting or changing Riluzole dose within 30 days of screening and/or Edaravone with 60 days of screening You have a significant pulmonary disorder not attributed to ALS or you require treatments that might complicate the evaluation of the effect of ALS on respiratory function (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension)
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