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

NCT04579666 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2025-04-24

Study results available
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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)

Conditions

Interventions

DRUG

Pegcetacoplan (APL-2)

Complement (C3) Inhibitor

OTHER

Placebo

Sterile solution of equal volume to active arm

Sponsors & Collaborators

  • Apellis 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
2020-09-30
Primary Completion
2023-03-31
Completion
2023-07-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • Ukraine
  • 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 NCT04579666 on ClinicalTrials.gov