MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Summary

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

Timeline

Start

2020-09-30

Primary completion

2023-03-31

Completion

2023-07-13

Outcome

Missed primary endpoint

Stopped: “The study did not meet primary endpoint at Week 52. The study also did not meet key secondary efficacy endpoints. Pegcetacoplan (APL-2) was well tolerated in the study, and the data were consistent with the established safety profile.”

registry analysis (superiority test); RTP: Pegcetacoplan vs RTP: Placebo; p = 0.7205; Difference in LS Mean -3.0 (95% CI -19.5 to 13.5); ANCOVA NCT04579666 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegcetacoplan	Peptide	1080 mg	Subcutaneous

Indications