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
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
- Amyotrophic Lateral Sclerosis
- Motor Neuron Disease
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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