Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Part of paid clinical trials in La Jolla, California.

Sponsor
Amgen
Study ID
NCT05549258
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Inebilizumab — DRUG
    Inebilizumab administered intravenously (IV) over a total of 28 weeks.

Study Details

A Phase 2, open-label, multicenter study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of inebilizumab in eligible pediatric participants 2 to \< 18 years of age with recently active neuromyelitis optica spectrum disorder (NMOSD) who are seropositive for autoantibodies against aquaporin-4 (AQP4-immunoglobulin \[Ig\]G).

Key Dates

Start date
Jul 3, 2023
Status verified
Dec 2025
Primary completion
Apr 13, 2027
Completion
Apr 13, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inebilizumab
    Infusion of Inebilizumab

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of Inebilizumab [ Time Frame: Day 1 to Week 28 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCSD Altman Clinical and Translational Research Institute BuildingLa JollaCalifornia92037-1337-
Loma Linda University Children's Hospital - PINLoma LindaCalifornia92354-
Massachusetts General HospitalBostonMassachusetts02115-
University of Texas Southwestern Medical CenterDallasTexas78701-

Find similar trials in La Jolla, CA

By research site
UCSD Altman Clinical and Translational Research Institute Building· La Jolla, CALoma Linda University Children's Hospital - PIN· Loma Linda, CAMassachusetts General Hospital· Boston, MAUniversity of Texas Southwestern Medical Center· Dallas, TX

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