Study 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)Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Interventional
Type of Intervention:
Drug, N/A
Intervention Name:
Pegcetacoplan (APL-2), Placebo
Placebo:
Yes
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Study Sponsor:
Apellis Pharmaceuticals, Inc.
Estimated Enrollment:
249
Estimated Study Start Date:
09 / 30 / 2020
Estimated Study Completion Date:
03 / 01 / 2024
Posting Last Modified Date:
06 / 01 / 2022
Date Study Added to neals.org:
10 / 08 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
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
Cedars-Sinai Medical Center
Los Angeles, California
90048
United States
University of Colorado
Aurora, Colorado
80045
United States
University of South Florida
Tampa, Florida
33612
United States
Augusta University
Augusta, Georgia
30912
United States
Indiana University
Indianapolis, Indiana
46202
United States
Johns Hopkins
Baltimore, Maryland
21205
United States
The Berman Center
Minneapolis, Minnesota
55415
United States
Hospital for Special Surgery
New York, New York
10021
United States
Austin Neuromuscular Center
Austin, Texas
78756
United States
University of Vermont Medical Center
Burlington, Vermont
05401
United States
Brain and Mind Centre
Camperdown, New South Wales
2050
Australia
Central Coast Neurosciences Research
Erina, New South Wales
2250
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland
4029
Australia
Gold Coast University Hospital
Southport, Queensland
4215
Australia
Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health
Heidelberg, Victoria
3084
Australia
AZ Sint-Lucas & Volkskliniek
Gent B-9000
Belgium
Universitaire Ziekenhuizen Leuven (UZ Leuven)
Leuven B-3000
Belgium
FORBELI s.r.o.
Prague 6 160 00
Czechia
Vseobecna fakultni nemocnice v Praze
Prague 2 128 21
Czechia
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
Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie
Rostock 18147
Germany
University of Ulm
Ulm 89081
Germany
Charité - Universitätsmedizin Berlin
Berlin D-13353
Germany
Universitätsklinikum Jena
Jena 07747
Germany
Medizinische Hochschule Hannover Klinik für Neurologie
Hannover 30625
Germany
Beaumont Hospital
Dublin DO9 V2NO
Ireland
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
National Hospital Organization Okinawa National Hospital
Okinawa 901-2214
Japan
Tokyo Medical University Hospital
Tokyo 160-0023
Japan
Juntendo University Hospital
Tokyo 113-8431
Japan
Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka 420-8688
Japan
National Hospital Organization Higashisaitama National Hospital
Saitama 349-0196
Japan
National Hospital Organization Higashinagoya National Hospital
Aichi 465-8620
Japan
Niigata National Hospital National Hospital Organization
Niigata 945-8585
Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto 399-8701
Japan
National Hospital Organization Iou National Hospital
Ishikawa 920-0192
Japan
National Hospital Organization Hyogo-Chuo National Hospital
Hyōgo 669-1592
Japan
National Hospital Organization Asahikawa Medical Center
Hokkaido 070-8644
Japan
National Hospital Organization Omuta National Hospital
Fukuoka 837-0911
Japan
University Medical Center Utrecht
Utrecht 3584 CX
Netherlands
City Clinic Sp. z o.o.
Warsaw 02-473
Poland
Centrum Medyczne NeuroProtect
Warsaw 01-684
Poland
Uniwersytecki Szpital Kliniczny w Olsztynie Klinika Neurologii
Olsztyn 10-082
Poland
Hospital Universitari Vall d'Hebron
Barcelona 08035
Spain
Bellvitge University Hospital
Barcelona 08907
Spain
Hospital Universitari I Politecnic La Fe
Valencia 46026
Spain
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv 61068
Ukraine
Centre of Reconstructive and Restorative Medicine (University Clinic) Odessa National Medical University
Odessa 65062
Ukraine
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya 69600
Ukraine
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