Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD (NCT06724809) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
China21 participantsStarted 2025-01-16
Plain-language summary
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion Criteria:
* Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria
* Anti-AQP4 antibody positive
* At least 1 attack or relapse in the last 12 months prior to the Screening Period
* EDSS score ≤ 7
* If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse
* Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening
* Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention:
* Refrain from donating fresh unwashed semen. PLUS, either,
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
* Must agree to use barrier as detailed below:
* Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.
Exclusion Criteria:
* Pregnant, breastfeeding, or intending to conceive during the course of the study
* Prior history of N meningitidis infection or unresolved meningococcal disease
* Any systemic bacterial or other infection which is clinically significant in the opinion…
What they're measuring
1
The efficacy of eculizumab in anti-AQP4 antibody positive participants with NMOSD measured by Adjudicated On-trial annualized relapse rate (ARR).
Timeframe: Baseline through Week 52
2
The efficacy of eculizumab in anti-AQP4 antibody positive participants with NMOSD measured by Adjudicated On-trial annualized relapse rate (ARR).