Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT05346354
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — DRUG
    Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance treatment with ravulizumab on Day 15 and every 8 weeks (q8w) after or once every 4 weeks (q4w) depending on weight. During the Extension Period, participants will continue to receive weight-based maintenance doses of ravulizumab IV on Day 351 and q8w or q4w, depending on weight.

Study Details

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).

Key Dates

Start date
Jun 23, 2022
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Apr 2, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ravulizumab
    During the Primary Treatment Period, all participants will receive weight-based dosing of ravulizumab IV for a total of 50 weeks of treatment. During the Extension Period, participants will continue to receive weight-based dosing of ravulizumab IV for up to 104 weeks.

Primary Outcome Measure

Change From Baseline in the Annualized Relapse Rate at Week 50 [ Time Frame: Baseline, Week 50 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteWashington D.C.District of Columbia20010-
Research SiteMiamiFlorida33136-
Research SiteBostonMassachusetts02114-
Research SiteSt LouisMissouri63110-
Research SiteDurhamNorth Carolina27705-
Research SitePhiladelphiaPennsylvania19104-

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Research Site· Washington D.C., DCResearch Site· Miami, FLResearch Site· Boston, MAResearch Site· St Louis, MOResearch Site· Durham, NCResearch Site· Philadelphia, PA

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