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NCT05549258 · ClinicalTrials.gov registry record · Phase 2
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
A Phase 2 study of Neuromyelitis Optica Spectrum Disorder, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 19
- Study locations
NCT05549258: Recruiting Phase 2 study of Neuromyelitis Optica Spectrum Disorder, sponsored by Amgen.
NCT05549258 is a Phase 2 study of Neuromyelitis Optica Spectrum Disorder that is actively recruiting participants, run by Amgen. The registered enrollment target is 15 participants, below the 64-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (77% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05549258, a Phase 2 study of Neuromyelitis Optica Spectrum Disorder, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 19
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Inebilizumab
Study Locations (19)
Other
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) - Porto Alegre/RS
- CPQuali Pesquisa Clínica Sao Paulo - São Paulo
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo
- Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17 - Gdansk
California
- UCSD Altman Clinical and Translational Research Institute Building - La Jolla
- Loma Linda University Children's Hospital - PIN - Loma Linda
London, City of
- Evelina London Children's Hospital - London
- Great Ormond Street Hospital - PPDS - London
Massachusetts
- Massachusetts General Hospital - Boston
Texas
- University of Texas Southwestern Medical Center - Dallas
Ciudad Autónoma de BuenosAires
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan - Parque Patricios
Estado de Bahia
- Hospital Santa Izabel-Rua Floriano Peixoto 300 - Salvador
Ontario
- Hospital For Sick Children - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-07-03 |
| Est. Completion | 2027-04-13 |
| Phase | Phase 2 |
What NCT05549258 shows while recruiting
NCT05549258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 64-participant average among 6 other Neuromyelitis Optica Spectrum Disorder trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Neuromyelitis Optica Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Inebilizumab is the first listed.
NCT05549258 lists 19 locations in 14 states (Other, California, London, City of).
Frequently Asked Questions
What is clinical trial NCT05549258 about?
NCT05549258 is a clinical study titled "Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder". 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 aga...
What is the current status of trial NCT05549258?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-07-03. Estimated completion is 2027-04-13.
What conditions does trial NCT05549258 study?
This clinical trial studies the following conditions: Neuromyelitis Optica Spectrum Disorder.
What interventions are being tested in trial NCT05549258?
The interventions under investigation include: Inebilizumab (DRUG).
Who is sponsoring clinical trial NCT05549258?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05549258 being conducted?
This trial has 19 study locations across California, Massachusetts, Texas, Ciudad Autónoma de BuenosAires, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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