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RecruitingPhase 3

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)

Hoffmann-La Roche · NCT05199688

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–11 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
8
US sites recruiting
1
Study start
May 6, 2026
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Satralizumab

Conditions: Neuromyelitis Optica Spectrum Disorder; NMOSD

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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:
  • Documented history of a positive anti-AQP4 antibody test or a positive anti-AQP4 antibody test at screening;
  • Neurological stability for >=30 days prior to baseline
  • Expanded Disability Status Scale (EDSS) 0 to 6.5
  • For participants receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline

Exclusion Criteria

  • 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
  • IVIg or subcutaneous Ig (SCIg) within 4 weeks prior to enrollment/Day 1

Recruiting US locations

  • Children's Hospital Colorado.

    Denver, CO 80218-1007

Study contacts (from the official record)

  • Reference Study ID Number: WN41733 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S.) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · global.medical_information@roche.com
A Study to Evaluate Pharmacokinetics, Efficacy, Safety,… (NCT05199688) | Bored Studies