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A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients with Aquaporin-4 (AQP4) Antibody Positive Neuromyelitis Optica Spectrum Disorder
EU CTIS ID: 2023-507817-85-00
What this study is testing
1. To investigate the pharmacokinetics (PK) of satralizumab by evaluating serum exposure over 24 weeks in participants aged 2-11 years, inclusive
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age at screening 2-11 years, inclusive
- 2. Body weight at screening ≥10 kg
- 3. For female participants of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception
- 4. Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria
- 5. Neurological stability for ≥30 days prior to both screening and baseline
- 6. Normal or abnormal neurologic status as described by EDSS (0 to 6.5)
You likely can't join if
- 1. Pregnancy or lactation
- 2. Evidence of other demyelinating disease mimicking NMOSD including but not limited to MS, myelin oligodendrocyte glycoprotein-IgG associated disease, or progressive multifocal leukoencephalopathy
- 3. Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection (excluding fungal infection of nail beds or dental caries) at baseline
- 4. Evidence of chronic active hepatitis B or C
- 5. Evidence of untreated latent or active tuberculosis (TB)
- 6. Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Turkey
- United States
- Argentina
- 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Turkey; United States; Argentina; United Kingdom. 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 EU CTIS; the study team decides eligibility.