Recruiting
Phase 3

Satralizumab

Sponsor:

Hoffmann-La Roche

Code:

NCT05199688

Conditions

Neuromyelitis Optica Spectrum Disorder

NMOSD

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

Interventions

Satralizumab

Study Details

Brief summary:

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.

Conditions

Neuromyelitis Optica Spectrum Disorder

NMOSD

Study ID

NCT05199688

Start date

May 6, 2026

Status verified date

Aug, 2026

Completion date

Sep 12, 2029

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

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
  • 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

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

Study Design

Enrollment

8 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Satralizumab

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.

Primary outcome measure

  • Summary of observed serum concentration [Cthrough] of satralizumab [ Time Frame: Week 48 ]
  • Apparent clearance [CL/F] of satralizumab [ Time Frame: Week 48 ]
  • Apparent volume of distribution [V/F] of satralizumab [ Time Frame: Week 48 ]
  • Area under the concentration-time curve [AUC] of satralizumab [ Time Frame: Week 48 ]

Central Contacts and Locations

Central contacts

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

Locations

Children's Hospital Colorado.

Recruiting

Denver, Colorado, United States, 80218-1007

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-11.