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)

Part of paid clinical trials in Denver, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT05199688
Phase
PHASE3
Status
Recruiting
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Conditions

  • NMOSD
  • Neuromyelitis Optica Spectrum Disorder

Eligibility Criteria

Sex
ALL
Age
2 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Satralizumab — DRUG
    Participants will receive satralizumab treatment for a minimum of 48 weeks and then will have the opportunity to enter an optional satralizumab extension (OSE) period.

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Sep 12, 2029

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Participants with body weight ≥10kg to <20kg
    Satralizumab will be administered SC Q6W in a cohort of at least 2 evaluable patients
  • Experimental: Cohort 2 Participants with body weight ≥20kg to <40kg
    Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter.
  • Experimental: Cohort 3 Participants with body weight ≥40kg
    Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter.

Primary Outcome Measure

Summary of observed serum concentration [Cthrough] of satralizumab [ Time Frame: Week 48 ]

Central Contacts

  • Reference Study ID Number: WN41733 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado.DenverColorado80218-1007-

Find similar trials in Denver, CO

By research site
Children's Hospital Colorado.· Denver, CO

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