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Monoclonal Antibodies

Satralizumab for Neuromyelitis Optica Spectrum Disorder (SAkuraSun Trial)

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age at screening 2-11 years, inclusive
Expanded Disability Status Scale (EDSS) 0 to 6.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24, week 48
Awards & highlights

SAkuraSun Trial Summary

This trial will study how well a new medication works in children with a rare nervous system disorder.

Who is the study for?
This trial is for children aged 2-11 with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are positive for anti-aquaporin-4 antibodies. They must weigh at least 10 kg, have a certain level of disability or less, and be neurologically stable for over a month before the trial. Girls able to have children must avoid pregnancy. Those on immunosuppressants need stable doses for 4 weeks.Check my eligibility
What is being tested?
The study tests Satralizumab in young NMOSD patients to understand how the drug moves through their bodies (pharmacokinetics). It also looks at how well it works (efficacy), its safety, tolerability, and effects on the disease process (pharmacodynamics) in a small patient group.See study design
What are the potential side effects?
While not detailed here, side effects may include typical reactions to biologic agents such as allergic responses, potential infections due to immune system suppression, injection site reactions, and possibly others based on adult experiences with Satralizumab.

SAkuraSun Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 2 and 11 years old.
Select...
My disability level allows me to walk at least 20 meters without aid.
Select...
I have NMOSD with AQP4 antibodies and had at least one attack in the last year.
Select...
My neurological condition has been stable for at least 30 days.

SAkuraSun Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24, week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24, week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent clearance [CL/F] of satralizumab
Apparent volume of distribution [V/F] of satralizumab
Area under the concentration-time curve [AUC] of satralizumab
+1 more
Secondary outcome measures
Annualized relapse rate (ARR), defined as the average number of relapses for each year of the study
Change from baseline in EuroQol 5-Dimension, Youth (EQ-5D-Y) score and its proxy at Weeks 24 and 48
Change from baseline in Expanded Disability Status Scale (EDSS) at Weeks 24 and 48
+6 more

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884
21%
Upper respiratory tract infection
18%
Nasopharyngitis
15%
Headache
13%
Anaemia
13%
Urinary tract infection
13%
Alanine aminotransferase increased
11%
Alopecia
11%
Hyperlipidaemia
11%
Vertigo
11%
Chest discomfort
11%
Complement factor decreased
11%
Conjunctivitis
10%
Leukopenia
10%
Lymphopenia
8%
Conjunctival haemorrhage
8%
Diarrhoea
8%
Arthralgia
8%
Oral herpes
8%
Cough
8%
Eczema
6%
Oral candidiasis
6%
Bradycardia
6%
Hypertransaminasaemia
6%
Retinal haemorrhage
6%
Hypofibrinogenaemia
6%
Left ventricle outflow tract obstruction
6%
Blepharospasm
6%
Conjunctival deposit
6%
Dry eye
6%
Glaucoma
6%
Excoriation
6%
Blood urine
6%
Protein urine present
6%
Dehydration
6%
Amenorrhoea
6%
Pharyngeal erythema
6%
Acne
6%
Intervertebral disc protrusion
6%
Muscle spasticity
6%
Blood alkaline phosphatase increased
6%
Polycythaemia
6%
Oedema peripheral
6%
Bacteriuria
6%
Pyelonephritis
6%
Respiratory tract infection
6%
Wound
6%
Epistaxis
6%
Musculoskeletal stiffness
6%
Large intestine polyp
6%
Pancreatitis acute
6%
Feeling abnormal
6%
Hepatic function abnormal
6%
Arthropod sting
6%
Feeling hot
6%
Pelvic fracture
6%
Osteoarthritis
6%
Nephrolithiasis
6%
Platelet count decreased
6%
Cataract
6%
Chills
6%
Contusion
6%
Serum ferritin decreased
6%
Dyspepsia
6%
Onychomycosis
6%
Viral upper respiratory tract infection
6%
Upper respiratory tract inflammation
6%
Plicated tongue
6%
Compression fracture
6%
Urobilinogen urine increased
6%
Neck pain
6%
Malaise
6%
Angina pectoris
6%
Abdominal distension
6%
Cellulitis
6%
Enterocolitis infectious
6%
Pneumonia
6%
Joint injury
6%
Weight increased
6%
Myopathy toxic
6%
Spinal osteoarthritis
6%
Epilepsy
6%
Lower limb fracture
6%
Low density lipoprotein increased
6%
Weight decreased
6%
Iron deficiency
6%
Erythema
6%
Rash pruritic
6%
Spinal pain
6%
Intercostal neuralgia
6%
Eye pruritus
6%
Panic disorder
5%
Pain in extremity
5%
Ear discomfort
5%
Neutropenia
5%
Bronchitis
5%
Rib fracture
5%
Constipation
5%
Gastritis
5%
Fall
5%
Cystitis
5%
Blepharitis
5%
Hypocomplementaemia
5%
Laryngitis
5%
Oropharyngeal pain
5%
Dental caries
5%
Sinusitis
5%
Thermal burn
5%
Dyslipidaemia
5%
Hypercholesterolaemia
5%
Myalgia
5%
Anxiety
5%
Flushing
5%
Hypertension
5%
Blood fibrinogen decreased
5%
Blood fibrinogen increased
5%
Blood pressure increased
5%
Prothrombin time prolonged
5%
Rhinorrhoea
5%
Rash
5%
Muscle spasms
3%
Lymphocyte percentage increased
3%
Cervical dysplasia
3%
Gait disturbance
3%
Vomiting
3%
Influenza
3%
Upper limb fracture
3%
Tonsillitis
3%
Haemoglobin decreased
3%
Toothache
3%
Pharyngitis
3%
Dizziness
3%
Hordeolum
3%
Haemorrhoids
3%
Insomnia
3%
Periodontitis
3%
Neutrophil count decreased
3%
White blood cell count decreased
3%
Back pain
3%
Parkinsonism
3%
White blood cell count increased
3%
Hepatitis E
3%
Spinal compression fracture
3%
Large intestine infection
3%
Forearm fracture
3%
Lumbar spinal stenosis
3%
Neuromyelitis optica pseudo relapse
3%
Iron deficiency anaemia
3%
Abdominal pain upper
3%
Rhinitis
3%
Aspartate aminotransferase increased
3%
Urticaria
3%
Blood creatine phosphokinase increased
3%
Lymphocyte count decreased
3%
Non-cardiac chest pain
3%
Neutrophil count increased
3%
Neutrophil percentage increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Double Blind Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Open Label Period
Satralizumab Open-Label Period

SAkuraSun Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3 Participants with body weight ≥40kgExperimental Treatment1 Intervention
Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter.
Group II: Cohort 2 Participants with body weight ≥20kg to <40kgExperimental Treatment1 Intervention
Satralizumab will be administered SC at Weeks 0, 2, 4, and Q4W thereafter.
Group III: Cohort 1: Participants with body weight ≥10kg to <20kgExperimental Treatment1 Intervention
Satralizumab will be administered SC Q6W in a cohort of at least 2 evaluable patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,414 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
123 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,514 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
123 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders

Media Library

Satralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05199688 — Phase 3
Neuromyelitis Optica Spectrum Disorders Research Study Groups: Cohort 3 Participants with body weight ≥40kg, Cohort 1: Participants with body weight ≥10kg to <20kg, Cohort 2 Participants with body weight ≥20kg to <40kg
Neuromyelitis Optica Spectrum Disorders Clinical Trial 2023: Satralizumab Highlights & Side Effects. Trial Name: NCT05199688 — Phase 3
Satralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199688 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I take part in this test if I qualify?

"The ideal candidate for this clinical trial must 2-11 years old, have a diagnosis of neuromyelitis optica, and there are only around 8 total spots available."

Answered by AI

Does the age restriction for this research project stop at 65 years old?

"Children that are older than 2 years old but younger than 11 years old are eligible for this clinical trial."

Answered by AI

Has the FDA cleared Satralizumab for use?

"There is existing clinical data that suggest Satralizumab's efficacy and safety, thus it received a 3."

Answered by AI

Can patients sign up for the trial at this time?

"That is correct. The information available on clinicaltrials.gov attests that this trial is currently seeking patients. This specific study was originally posted on 30th November 2022 and was most recently updated on 1st November 2022. There are 8 subjects required for the trial, which will be conducted between 2 different sites."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
New York
Recent research and studies
clinicaltrials.govStudy
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)
2024. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05199688.
~5 spots leftby Mar 2027
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