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Quick Info
Currently Recruiting
Trial Type
Treatment Type
Drug Trials
Start Date
Contact Information
    Contact information unknown.
Australia, Other
Central Coast Neurosciences Research, Erina, 2250, Australia
Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health, Heidelberg, 3084, Australia
Royal Brisbane and Women's Hospital, Herston, 4029, Australia
Belgium, Other
AZ Sint-Lucas & Volkskliniek, Gent, B-9000, Belgium
Universitaire Ziekenhuizen Leuven (UZ Leuven), Leuven, B-3000, Belgium
France, Other
CHU Gabriel Montpied, Clermont-Ferrand, 63000, France
CHU de Nice Hôpital Pasteur, Nice, 6300, France
Germany, Other
Charité - Universitätsmedizin Berlin, Berlin, D-13353, Germany
Medizinische Hochschule Hannover Klinik für Neurologie, Hannover, 30625, Germany
Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie, Rostock, 18147, Germany
University of Ulm, Ulm, 89081, Germany
Italy, Other
Ospedale Niguarda - Nemo Clinical Center - Fondazione Serena Onlus, Milano, 20162, Italy
AOUP "P. Giaccone", Palermo, 90129, Italy
Azienda Ospedaliera Universitaria di Torino - Città della Salute e della Scienza di Torino, Torino, 10126, Italy
Other, Other
Vseobecna fakultni nemocnice v Praze, Prague 2, 128 21, Other
FORBELI s.r.o., Prague 6, 160 00, Other
Poland, Other
Uniwersytecki Szpital Kliniczny w Olsztynie Klinika Neurologii, Olsztyn, 10-082, Poland
Centrum Medyczne NeuroProtect, Warsaw, 01-684, Poland
City Clinic Sp. z o.o., Warsaw, 02-473, Poland
Spain, Other
Hospital Universitari Vall d'Hebron, Barcelona, 08035, Spain
Bellvitge University Hospital, Barcelona, 08907, Spain
Hospital Universitari I Politecnic La Fe, Valencia, 46026, Spain
United States, Florida
University of South Florida, Tampa, FL, 33612, United States
United States, Georgia
Augusta University, Augusta, GA, 30912, United States
United States, Indiana
Indiana University, Indianapolis, IN, 46202, United States
United States, Maryland
Johns Hopkins, Baltimore, MD, 21205, United States
United States, Minnesota
The Berman Center, Minneapolis, MN, 55415, United States
United States, New York
Hospital for Special Surgery, New York, NY, 10021, United States
United States, Texas
Austin Neuromuscular Center, Austin, TX, 78756, United States
United States, Vermont
University of Vermont Medical Center, Burlington, VT, 05401, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
Months Since Onset
Number of months since first symptoms of ALS.
18 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Open Label
Update Notes
New sites added
Add locations in New York and Australia.
Sites added
Sites added
Sites added
SItes added

Other Information

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)
Inclusion Criteria:
- 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 Exclusion Criteria:
- 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
  • Apellis Pharmaceuticals, Inc.
Trial Protocol as Published on
NCT04579666 (First Published: 9/22/2020)