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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis, Motor Neuron Disease

In brief

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)

Key facts

Study ID: NCT04579666
Run by: Apellis Pharmaceuticals, Inc.
People needed: 249
Starts: 2020-09-30
Expected to finish: 2023-07-13
Last updated by the study team: 2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

At least 18 years of age
Sporadic ALS diagnosed as definite, probable, or laboratory-supported probable as defined by the revised El Escorial criteria
Slow vital capacity (SVC) ≥60% of the predicted value at screening
Onset of ALS symptoms within 72 weeks (18 months) prior to screening
Total ALSFRS-R score of ≥30 at screening
Have vaccination within 5 years against Streptococcus pneumoniae, Neisseria meningitidis (types A, C, W, Y, and B), and Haemophilus influenzae (type B) or agree to receive vaccination

You may not qualify if…

Confirmed or suspected other causes of neuromuscular weakness
Diagnosed with another neurodegenerative disease (examples include Parkinson's disease and Huntington's disease)
Significant pulmonary disorder not attributed to ALS (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension)
If taking riluzole, participant must be on a stable dose for 30 days prior to the start of the screening period. Use of riluzole is not required for participation.
If taking edaravone, participant must be on a stable dose for 60 days prior to the start of the screening period. Use of edaravone is not required for participation.
Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation
Use of any other complement inhibitor within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation

Where it is running

University of Colorado — Aurora, Colorado, United States
University of South Florida — Tampa, Florida, United States
Augusta University — Augusta, Georgia, United States
Indiana University — Indianapolis, Indiana, United States
Johns Hopkins — Baltimore, Maryland, United States
The Berman Center — Minneapolis, Minnesota, United States
Hospital for Special Surgery — New York, New York, United States
Austin Neuromuscular Center — Austin, Texas, United States
University of Vermont Medical Center — Burlington, Vermont, United States
Brain and Mind Centre — Camperdown, New South Wales, Australia
Central Coast Neurosciences Research — Erina, New South Wales, Australia
Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
Gold Coast University Hospital — Southport, Queensland, Australia
Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health — Heidelberg, Victoria, Australia
AZ Sint-Lucas & Volkskliniek — Ghent, Belgium
Universitaire Ziekenhuizen Leuven (UZ Leuven) — Leuven, Belgium
Vseobecna fakultni nemocnice v Praze — Prague, Czechia
FORBELI s.r.o. — Prague, Czechia
Hopital Pellegrin — Bordeaux, France
Hôpital Neurologique Pierre Wertheimer — Bron, France
CHU Gabriel Montpied — Clermont-Ferrand, France
Hôpital Roger Salengro — Lille, France
CHU de Limoges Dupuytren 1 — Limoges, France
CHU de Nice Hôpital Pasteur — Nice, France
Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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