An Efficacy and Safety Study of Ravulizumab in ALS Participants
Study Identifier:
ALXN1210-ALS-308
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Metabolism & Nutrition - Other
- Unmapped
Study Drug
- Drug: Placebo
- Biological: Ravulizumab
Date
Mar 2020 - Oct 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
- ALS onset ≤ 36 months from Screening.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Upright slow vital capacity ≥ 65% predicted at Screening.
- If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
- Body weight ≥ 40 kilograms at Screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
- Dependence on invasive or non-invasive mechanical ventilation.
- Previously or currently treated with a complement inhibitor.
- Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Metabolism & Nutrition - Other
- Unmapped
Study Drug
- Drug: Placebo
- Biological: Ravulizumab
Date
Mar 2020 - Oct 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
- ALS onset ≤ 36 months from Screening.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Upright slow vital capacity ≥ 65% predicted at Screening.
- If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
- Body weight ≥ 40 kilograms at Screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
- Dependence on invasive or non-invasive mechanical ventilation.
- Previously or currently treated with a complement inhibitor.
- Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Protocol Summary
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
Trial Locations
Location
Status
Location
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Status
N/A
Location
Neuromuscular Research Center and Clinic
Phoenix, Arizona, United States, 85028
Status
N/A
Location
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85251
Status
N/A
Location
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Status
N/A
Location
University of Southern California
Los Angeles, California, United States, 90033
Status
N/A
Location
University of California-Irvine
Orange, California, United States, 92868
Status
N/A
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