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Tests treatment safety and results for Neuromyelitis Optica Spectrum Disorder
Official title A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
ClinicalTrials.gov ID: NCT05199688
What this study is testing
What is Satralizumab?
Satralizumab is an investigational medicine, being studied as a potential treatment for neuromyelitis optica spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 11
You may be able to join if
- Age at screening 2-11 years, inclusive
- Body weight at screening \>=10 kg
- For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual...
- Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one...
- Neurological stability for \>=30 days prior to both screening and baseline
You likely can't join if
- Pregnancy or lactation
- Evidence of other demyelinating disease mimicking NMOSD
- Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
- Evidence of chronic active hepatitis B or C
- Evidence of untreated latent or active tuberculosis (TB)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
See the full eligibility criteria
- Age at screening 2-11 years, inclusive
- Body weight at screening \>=10 kg
- For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception
- Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening
- Neurological stability for \>=30 days prior to both screening and baseline
- Expanded Disability Status Scale (EDSS) 0 to 6.5
- For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline
- Pregnancy or lactation
- Evidence of other demyelinating disease mimicking NMOSD
- Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
- Evidence of chronic active hepatitis B or C
- Evidence of untreated latent or active tuberculosis (TB)
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
- History of severe allergic reaction to a biologic agent
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Ciudad Autonoma Buenos Aires, Argentina
- Córdoba, Argentina
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
- Le Kremlin-Bicêtre, France
- Rome, Lazio, Italy
- Pavia, Lombardy, Italy
- DF, Mexico CITY (federal District), Mexico
- Gdansk, Poland
- Warsaw, Poland
- Kocaeli, Turkey (Türkiye)
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Ciudad Autonoma Buenos Aires, Argentina; Córdoba, Argentina; Guangzhou, Guangdong, China; Shanghai, Shanghai Municipality, China; Le Kremlin-Bicêtre, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.