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Quick Info
Status
Ongoing, But Not Recruiting
Phase
2
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
2:1
Enrollment
249
Start Date
9/30/2020
Contact Information
    Contact information unknown.
Locations
Australia, Other
Brain and Mind Centre, Camperdown, 2050, Australia
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
Gold Coast University Hospital, Southport, 4215, Australia
Belgium, Other
AZ Sint-Lucas & Volkskliniek, Gent, B-9000, Belgium
Universitaire Ziekenhuizen Leuven (UZ Leuven), Leuven, B-3000, Belgium
France, Other
Hopital Pellegrin, Bordeaux, 33076, France
Hôpital Neurologique Pierre Wertheimer, Bron, 69677, France
CHU Gabriel Montpied, Clermont-Ferrand, 63000, France
Hôpital Roger Salengro, Lille, 59037, France
CHU de Limoges Dupuytren 1, Limoges, 87042, 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
Universitätsklinikum Jena, Jena, 07747, Germany
Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie, Rostock, 18147, Germany
University of Ulm, Ulm, 89081, Germany
Ireland, Other
Beaumont Hospital, Dublin, DO9 V2NO, Ireland
Italy, Other
Ospedale Niguarda - Nemo Clinical Center - Fondazione Serena Onlus, Milano, 20162, Italy
Ospedale Civile S. Agostino Estense di Modena, Azienda Ospedaliero Universitaria di Modena, Modena, 41126, Italy
AOUP "P. Giaccone", Palermo, 90129, Italy
Azienda Ospedaliera Universitaria di Torino - Città della Salute e della Scienza di Torino, Torino, 10126, Italy
Japan, Other
National Hospital Organization Higashinagoya National Hospital, Aichi, 465-8620, Japan
National Hospital Organization Omuta National Hospital, Fukuoka, 837-0911, Japan
National Hospital Organization Asahikawa Medical Center, Hokkaido, 070-8644, Japan
National Hospital Organization Hyogo-Chuo National Hospital, Hyōgo, 669-1592, Japan
National Hospital Organization Iou National Hospital, Ishikawa, 920-0192, Japan
National Hospital Organization Matsumoto Medical Center, Matsumoto, 399-8701, Japan
Niigata National Hospital National Hospital Organization, Niigata, 945-8585, Japan
National Hospital Organization Okinawa National Hospital, Okinawa, 901-2214, Japan
National Hospital Organization Higashisaitama National Hospital, Saitama, 349-0196, Japan
Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, 420-8688, Japan
Juntendo University Hospital, Tokyo, 113-8431, Japan
Tokyo Medical University Hospital, Tokyo, 160-0023, Japan
Netherlands, Other
University Medical Center Utrecht, Utrecht, 3584 CX, Netherlands
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
Ukraine, Other
SI Institute of Neurology, Psychiatry and Narcology of NAMSU, Kharkiv, 61068, Ukraine
Centre of Reconstructive and Restorative Medicine (University Clinic) Odessa National Medical Univer, Odessa, 65062, Ukraine
Zaporizhzhya Regional Clinical Hospital, Zaporizhzhya, 69600, Ukraine
United Kingdom, Other
University Hospitals Sussex NHS Foundation Trust, Brighton, BN2 5BE, United Kingdom
Maurice Wohl Clinical Neuroscience Institute, King's College London, London, SE5 9RX, United Kingdom
St George's University Hospitals NHS Foundation Trust, London, SW17 0WT, United Kingdom
United States, California
Cedars-Sinai Medical Center, Los Angeles, CA, 90048, United States
United States, Colorado
University of Colorado, Aurora, CO, 80045, United States
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)
N/A
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?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
Study no longer recruiting
6/6/2022
New sites added
10/13/2021
New sites added
8/16/2021
Add locations in New York and Australia.
7/23/2021
Sites added
7/7/2021
Sites added
5/25/2021
Sites added
4/21/2021
SItes added
4/6/2021

Other Information

Purpose
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)
Eligibility
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
Details
Collaborator(s)
  • Apellis Pharmaceuticals, Inc.
Trial Protocol as Published on Clinicaltrials.gov
NCT04579666 (First Published: 9/22/2020)