Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD (NCT05346354) | Clinical Trial Compass
RecruitingPhase 2/3
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
United States12 participantsStarted 2022-06-23
Plain-language summary
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
Who can participate
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Inclusion Criteria:
* Participants must be anti-AQP4 Ab-positive and have a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
* Complement inhibitor treatment-naĂ¯ve participants must have had at least 1 attack or relapse in the last 12 months prior to the Screening Period.
* Expanded Disability Status Scale (EDSS) score ≤ 7.
* Eculizumab-experienced participants must be clinically stable per Investigator for 30 days and have been treated with eculizumab in Study ECU-NMO-303 for at least 90 days prior to screening with no missed doses within 2 months prior to Day 1.
* Participants who enter the study receiving supportive IST(s) (eg, corticosteroid, azathioprine \[AZA\], mycophenolate mofetil \[MMF\], methotrexate \[MTX\], tacrolimus \[TAC\], cyclosporin \[CsA\], or cyclophosphamide \[CYC\]) for the prevention of relapse, either in combination or monotherapy, must be on a stable dosing regimen of adequate duration prior to Screening and remain on a stable dosing regimen during the Screening Period.
* To reduce the risk of meningococcal infection (Neisseria meningitidis), all participants must be vaccinated against meningococcal infection.
* Documented vaccination for Hib and S pneumoniae at least 14 days prior to Day 1 according to national/local guidelines for the applicable age group.
Exclusion Criteria:
* Use of rituximab within 3 months prior to screening.
* Currently treated with a biologic medications (other than eculizumab) that ma…
What they're measuring
1
Change From Baseline in the Annualized Relapse Rate at Week 50
Timeframe: Baseline, Week 50
2
Time to First Adjudicated On-trial Relapse through Week 50