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Monoclonal Antibodies
Satralizumab for Thyroid Eye Disease (SatraGO-2 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
- Clinical diagnosis of thyroid eye disease (TED) based on CAS
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
SatraGO-2 Trial Summary
This trial studies the effects of an anti-IL-6 antibody on people with thyroid eye disease.
Who is the study for?
This trial is for individuals with thyroid eye disease (TED), confirmed by a clinical diagnosis. Participants must meet specific medical criteria to join.Check my eligibility
What is being tested?
The study tests satralizumab, an antibody targeting the IL-6 receptor, against a placebo in patients with TED to evaluate its effectiveness and safety.See study design
What are the potential side effects?
Potential side effects of satralizumab may include reactions at the injection site, increased risk of infections, headaches, and possible abnormalities in liver function tests.
SatraGO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSatraGO-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
Secondary outcome measures
Change in proptosis from baseline to Week 24
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)
Side 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
SatraGO-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SatralizumabExperimental Treatment1 Intervention
In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study
Group II: PlaceboPlacebo Group1 Intervention
In the part I period, participants will receive placebo every 4 weeks (q4w) followed by proptosis response-based individualized treatment in part II of the study
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
2,432 Previous Clinical Trials
1,090,041 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,758 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Satralizumab been sanctioned by the Food and Drug Administration?
"Satralizumab's efficacy has been established in prior studies, leading to it being rated 3 out of a possible 3 for safety. Multiple rounds of data have supported this evaluation."
Answered by AI
How many participants are being recruited for the research study?
"Affirmative. Information hosted on clinicaltrials.gov reveals that the trial, which was first posted on November 15th 2023, is currently enrolling patients. A total of 120 participants are needed to be recruited from 6 different research centres."
Answered by AI
In what geographical locations is this research project being conducted?
"There are 6 medical centres offering this trial such as the Scheie Eye Institute in Philadelphia, Beijing Hospital of Ministry of Health in Beijing, and Peking University Third Hospital in Xi'an City."
Answered by AI
Are there any vacancies left for participants in this research project?
"Affirmative. Clinicaltrials.gov's records indicate that this clinical trial is actively enrolling patients, which has been listed since November 15th 2023 and was last updated on December 1st 2023. The experiment seeks to enlist 120 people from 6 different sites."
Answered by AI
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