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Monoclonal Antibodies
Satralizumab for MOG Antibody Disease (Meteoroid 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
Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
Participants who are aged >=12 years at the time of signing Informed Consent Form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 44 months
Awards & highlights
Meteoroid Trial Summary
This trial is testing if a potential new medication, satralizumab, is better than placebo at preventing people with a certain kind of autoimmune disease from relapsing.
Who is the study for?
This trial is for people aged 12 and older with confirmed MOGAD who've had at least one relapse in the past year or two in the last two years. Participants must not be pregnant, agree to use contraception, have a certain level of disability (EDSS score 0-6.5), and good vision (BCVA better than 20/800). They can't join if they have other antibodies, infections, hepatitis B/C, are pregnant/breastfeeding, recently vaccinated with live vaccines, severe allergies to biologics or need high doses of steroids.Check my eligibility
What is being tested?
The study tests whether Satralizumab is more effective than a placebo in preventing relapses in patients with MOGAD. It measures the time until a participant has their first relapse after starting treatment during a double-blind period where neither doctors nor participants know who's getting Satralizumab or placebo.See study design
What are the potential side effects?
Satralizumab may cause side effects such as potential allergic reactions due to it being a biological agent. The exact side effects aren't listed here but typically include symptoms related to immune system changes since it targets specific pathways involved in inflammation.
Meteoroid Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on or am currently taking long-term immune system suppression medication for MOGAD.
Select...
I am 12 years old or older.
Select...
My disability level allows me to walk at least 100 meters without aid or rest.
Meteoroid Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 44 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)
Secondary outcome measures
Annualized rate of active lesions on MRI of the neuroaxis
Annualized rate of adjudicated MOGAD relapses
Annualized rate of inpatient hospitalizations
+1 moreSide effects data
From 2021 Phase 3 trial • 85 Patients • NCT0202888421%
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
Meteoroid Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: SatralizumabExperimental Treatment1 Intervention
In the double-blind treatment period, participants will receive satralizumab at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
Group II: Group B: PlaceboPlacebo Group1 Intervention
In the double-blind treatment period, participants will receive satralizumab matching placebo at Weeks 0, 2, 4 (loading doses) and maintenance doses every 4 weeks (Q4W) thereafter. In the OLE period, all participants will receive open label treatment with satralizumab.
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
1,089,270 Total Patients Enrolled
1 Trials studying Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
7,000 Patients Enrolled for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,552 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,370 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized the use of Satralizumab?
"There is some evidence from prior clinical trials to support the safety of satralizumab, thus it received a score of 3."
Answered by AI
Are new patients still being accepted into this experiment?
"That is accurate. The listed clinical trial on clinicaltrials.gov is looking for 152 patients across 21 sites. The trial was first posted on October 30th, 2020 and was last updated on October 26th, 2020."
Answered by AI
How many research subjects are you looking for in total?
"152 patients that meet the requirements will be recruited in order to run this study. The sponsor, Hoffmann-La Roche, will be conducting the trial at various locations, including Mayo Clinic - Rochester in Rochester, Minnesota and University of Cincinnati; Department of Neurology in Cincinnati, Ohio."
Answered by AI
Are there multiple facilities administering this trial in the metropolitan area?
"In total, there are 21 different recruitment sites for this study. For example, Mayo Clinic - Rochester in Rochester, University of Cincinnati; Department of Neurology in Cincinnati, and Premier Neurology in Greer are all participating."
Answered by AI
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