AP101-02
A phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS)
AP101 is a specific antibody directed against the pathogenic form of the SOD1 protein . You have a 66% chance of receiving AP101 and a 33% chance of receiving placebo in this study.
The study consists of 2 periods:
- a 6-month double blind period in which you will receive study product or placebo;
- followed by an open label period during which 6 months of AP101 will be administered.
Study product AP101 or placebo will be administered tri-weekly by infusion. This will be followed by a 4-month follow up period to monitor the safety of the product.
Pre-participation will be screened to determine patient eligibility for this study.
A maximum of 63 patients will participate worldwide.
Learn more about this study at https://clinicaltrials.gov/ct2/show/NCT05039099
