Evaluating satralizumab for children with neuromyelitis optica spectrum disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the pharmacokinetics, efficacy, safety, tolerability, and pharmacodynamics of satralizumab in pediatric patients aged 2 to 11 years who are positive for anti-aquaporin-4 antibodies and diagnosed with neuromyelitis optica spectrum disorder (NMOSD). The study aims to gather descriptive data on these parameters, given the limited number of eligible patients. Participants must have experienced at least one documented attack of NMOSD in the past year and demonstrate neurological stability prior to the study. The treatment will be administered while monitoring the patients closely for safety and efficacy outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Colorado.
  Denver, Colorado, United States Recruiting
• Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
  Ciudad Autonoma Buenos Aires, Argentina Recruiting
• Clinica Universitaria Reina Fabiola
  Córdoba, Argentina Recruiting
• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting
• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Centre Hospitalier Universitaire de Bicêtre
  Le Kremlin-Bicêtre, Val-de-Marne, France Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WN41733 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S.)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ravulizumab in Chinese adults with NMOSD

  This study tests ravulizumab in Chinese adults with NMOSD who are AQP4 antibody positive to see if it helps reduce relapses and is safe.

  Recruiting Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07557420

• Rituximab vs multiple approved NMOSD therapies to prevent relapses

  This study tests whether rituximab or one of four other approved medicines is better at preventing NMOSD relapses in adults who have AQP4-IgG.

  Recruiting at 2 sites Phase 4 Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT07010302

• Registry of patients with AQP4+ NMOSD treated with C5 inhibitors

  This study is collecting information from people with AQP4+ NMOSD who are being treated with C5 inhibitors to see how well these treatments work and how they affect daily life over five years.

  Recruiting at 23 sites Alexion Pharmaceuticals, Inc. · Washington D.C., District of Columbia and 32 other locations · NCT05966467

• Satralizumab in the early treatment of NMOSD attacks: a multicenter real-world study

  This study tests whether starting Satralizumab during an NMOSD attack is safe and helpful for adults with AQP4-IgG–positive NMOSD.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07762872

• Transcranial alternating current stimulation for cognitive problems in inflammatory demyelinating CNS disorders

  This trial will try transcranial alternating current stimulation to see if it improves thinking and memory in adults with multiple sclerosis and related inflammatory demyelinating central nervous system disorders.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07087873

• Pregnancy registry for women with chronic neurological conditions

  This study is collecting information and samples from pregnant women with chronic neurological conditions to see how pregnancy affects their health and their baby's development.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06940323

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.