Your support fuels our research to #EndALS!
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, 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
There are no update notes for this clinical trial.

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)