Study Summary
This trial will study how well a new medication works in children with a rare nervous system disorder.
Eligible Conditions
- Neuromyelitis Optica Spectrum Disorder
- Neuromyelitis Optica Spectrum Disorders
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Baseline, Week 24, Week 48
Week 48
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
Change from baseline in FACES Pain Rating Scale at Weeks 24 and 48
Change from baseline in visual acuity at Weeks 24 and 48
Week 48
Annualized relapse rate (ARR), defined as the average number of relapses for each year of the study
Apparent clearance [CL/F] of satralizumab
Apparent volume of distribution [V/F] of satralizumab
Area under the concentration-time curve [AUC] of satralizumab
Incidence and severity of adverse events
Proportion of relapse-free patients by Week 48
Summary of observed serum concentration [Cthrough] of satralizumab
Time to first relapse (TFR) after randomization, defined as the time from randomization until the first occurrence of relapse, as determined by the investigator
Time to relapse requiring rescue therapy
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Satralizumab + Baseline Treatment, DB Period
24%Nasopharyngitis
24%Headache
24%Upper respiratory tract infection
15%Urinary tract infection
15%Leukopenia
10%Back pain
10%Pharyngitis
10%Hypercholesterolaemia
10%Gastritis
10%Arthralgia
7%Sinusitis
7%Lymphopenia
7%Anaemia
7%Nausea
7%Rhinitis
7%Hypertension
7%Oropharyngeal pain
7%Urticaria
7%Cystitis
5%Fatigue
5%Iron deficiency
5%Abdominal pain
5%Oral herpes
5%Anxiety
5%Dental caries
5%Neutropenia
5%Vertigo
5%Constipation
5%Herpes zoster
5%Leukocyturia
5%Dizziness
5%Eczema
5%Chest discomfort
5%Compression fracture
5%Neutrophil count decreased
5%Epistaxis
5%Low density lipoprotein increased
5%Spinal pain
5%Hyperlipidaemia
5%Iron deficiency anaemia
2%Malaise
2%Protein urine present
2%Pain in extremity
2%Thermal burn
2%Intercostal neuralgia
2%Dyslipidaemia
2%Ligament sprain
2%Dyspepsia
2%Plicated tongue
2%Chills
2%Arthropod sting
2%Wound
2%Urobilinogen urine increased
2%Feeling hot
2%Blood alkaline phosphatase increased
2%Amenorrhoea
2%Retinal haemorrhage
2%Alanine aminotransferase increased
2%Onychomycosis
2%Rhinorrhoea
2%Spinal compression fracture
2%Anaemia macrocytic
2%Femur fracture
2%Tension headache
2%Suicide attempt
2%Abdominal pain upper
2%Aspartate aminotransferase increased
2%Myalgia
2%Flushing
2%Hypofibrinogenaemia
2%Polycythaemia
2%Dry eye
2%Abdominal distension
2%Hypertransaminasaemia
2%Viral upper respiratory tract infection
2%Blood creatine phosphokinase increased
2%Weight decreased
2%Myopathy toxic
2%Osteoarthritis
2%Spinal osteoarthritis
2%Acne
2%Neck pain
2%Hypoaesthesia
2%Musculoskeletal stiffness
2%Pneumonia
2%Cough
2%Angina pectoris
2%Periodontitis
2%Contusion
2%Lower limb fracture
2%Lymphocyte count decreased
2%White blood cell count decreased
2%Serum ferritin decreased
2%Alopecia
2%Erythema
2%Rash pruritic
2%Bradycardia
2%Large intestine polyp
2%Excoriation
2%Depression
2%Cervical dysplasia
2%Cataract
2%Weight increased
2%Oedema peripheral
2%Conjunctival haemorrhage
2%Diarrhoea
2%Insomnia
Trial Design
3 Treatment Groups
Cohort 2 Participants with body weight ≥20kg to <40kg
1 of 3
Cohort 1: Participants with body weight ≥10kg to <20kg
1 of 3
Cohort 3 Participants with body weight ≥40kg
1 of 3
Experimental Treatment
8 Total Participants · 3 Treatment Groups
Primary Treatment: Satralizumab · No Placebo Group · Phase 3
Cohort 2 Participants with body weight ≥20kg to <40kg
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: DrugCohort 1: Participants with body weight ≥10kg to <20kg
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: DrugCohort 3 Participants with body weight ≥40kg
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 24, week 48
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,068,073 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
219 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Clinical TrialsStudy DirectorHoffmann-La Roche
2,147 Previous Clinical Trials
876,127 Total Patients Enrolled
2 Trials studying Neuromyelitis Optica Spectrum Disorders
219 Patients Enrolled for Neuromyelitis Optica Spectrum Disorders
Eligibility Criteria
Age 2 - 11 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The person must be neurologically stable for at least 30 days before both the screening and the baseline tests.
Serum AQP4 antibody titer ≥ 1 : 4,000 by enzyme-linked immunosorbent assay (ELISA)
People with NMOSD who have an AQP4 antibody titer of 1:4,000 or greater are defined as seropositive for NMOSD.
The study included children aged 2-11 years.
The body weight of the person is 10 kg or more at the screening.
For female patients of childbearing potential: Agreement to either remain completely abstinent or to use a reliable means of contraception.
The EDSS score ranges from 0 to 6.5, with a higher score indicating a more severe level of disability
visit
If you're receiving a baseline immunosuppressant treatment and plan to continue on these therapies, your treatment must be at a stable dose for four weeks prior to your baseline visit.
Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments