Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-17
SponsorAmgen
About this trial
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).
Eligibility criteria
Qualifiers
Male or female participants, minimum body weight of 15 kg, age 2 to < 18 years at the time of screening.
Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.
Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.
Disqualifiers
Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of participant safety or study results.
Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to Day 1.
Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period).
B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory.
Trial design
Treatments tested in this trial
- Inebilizumab
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov