MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

  • STATUS
    Recruiting
  • End date
    Oct 19, 2023
  • participants needed
    228
  • sponsor
    Apellis Pharmaceuticals, Inc.
Updated on 19 August 2021
primary lateral sclerosis

Summary

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)

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment Placebo, Pegcetacoplan (APL-2)
Clinical Study IdentifierNCT04579666
SponsorApellis Pharmaceuticals, Inc.
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

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
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