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Quick Info
Status
Currently Recruiting
Phase
2
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
2:1
Enrollment
228
Start Date
9/30/2020
Contact Information
    Contact information unknown.
Locations
United States, Florida
University of South Florida, Tampa, FL, 33612, 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, Texas
Austin Neuromuscular Center, Austin, TX, 78756, 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
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)