CompletedPhase 3

An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

United States58 participantsStarted 2019-12-09

Plain-language summary

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
✓. At least 1 attack or relapse in the last 12 months prior to the Screening Period.
✓. Expanded Disability Status Scale score ≤7.
✓. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
✓. Body weight ≥40 kilograms.
✓. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

✕. History of Neisseria meningitidis infection.
✕. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
✕. Previously or currently treated with a complement inhibitor.
✕. Use of rituximab or mitoxantrone within 3 months prior to Screening.
✕. Use of IV immunoglobulin within 3 weeks prior to Screening.

Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period

Timeframe: Baseline up to 2.25 years (end of the Primary Treatment Period)

NCT IDNCT04201262

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-15

Results submitted2023-05-31