Your session is about to expire
← Back to Search
Monoclonal Antibodies
Satralizumab for Duchenne Muscular Dystrophy (SHIELD DMD Trial)
Phase 2
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
A definitive diagnosis of DMD prior to screening based on documentation of clinical findings and prior confirmatory genetic testing using a clinical diagnostic genetic test
Evidence of at least one prevalent vertebral compression fracture of Genant Grade 1 or higher (or radiographic signs of VF) or history of at least one low-trauma long-bone fracture (upper or lower extremity)
Must not have
Major surgery (e.g. spinal surgery) within 3 months prior to Baseline or planned surgery or procedure that would interfere with the conduct of the study for any time during this study
Presence of any clinically significant illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to evaluate how well satralizumab, a type of medication, works in children with Duchenne muscular dystrophy who are between 8 and 16 years old. The study
Who is the study for?
This trial is for boys aged 8 to less than 16 with Duchenne Muscular Dystrophy (DMD) who can walk or not and are on corticosteroid therapy. Details about specific inclusion and exclusion criteria are not provided, but typically these would outline health requirements and any medications or conditions that might interfere with the study.
What is being tested?
The trial is testing Satralizumab, an antibody targeting the IL-6 receptor, which may affect inflammation. It aims to see how well it works (efficacy), its safety profile, how the body processes it (pharmacokinetics), and how it affects the body's response (pharmacodynamics).
What are the potential side effects?
While specific side effects of Satralizumab in this context aren't listed here, similar drugs often cause immune system changes leading to infections, potential liver issues, allergic reactions, infusion-related reactions, and possible impacts on blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of DMD based on genetic testing.
Select...
I have had a fracture in my spine or a major bone from a minor injury.
Select...
I was assigned male at birth.
Select...
I am between 8 and 15 years old.
Select...
I have never had a fracture from a minor injury or signs of vertebral fractures.
Select...
I can walk on my own without help and I am between 8 and 12 years old.
Select...
I am between 12 and 16 years old and cannot walk.
Select...
I take corticosteroids by mouth every day.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had major surgery in the last 3 months and don't plan any that could affect this study.
Select...
I have a serious health condition.
Select...
I have had a serious infection like pneumonia or meningitis in the last 4 weeks.
Select...
I don't have conditions like severe scoliosis that could affect spine density tests.
Select...
My body weight is over 100 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline to Week 52 in Lumbar Spine (LS) Bone Mineral Density (BMD) Z-Score Measured By Dual-Energy X-ray Absorptiometry (DEXA)
Secondary study objectives
Apparent Clearance of Satralizumab
Apparent Volume of Distribution of Satralizumab
Area Under the Concentration-Time Curve of Satralizumab
+5 moreSide effects data
From 2021 Phase 3 trial • 85 Patients • NCT0202888421%
Upper respiratory tract infection
18%
Nasopharyngitis
15%
Headache
13%
Urinary tract infection
13%
Alanine aminotransferase increased
13%
Anaemia
11%
Alopecia
11%
Hyperlipidaemia
11%
Vertigo
11%
Chest discomfort
11%
Complement factor decreased
11%
Conjunctivitis
10%
Lymphopenia
10%
Leukopenia
8%
Arthralgia
8%
Cough
8%
Eczema
8%
Conjunctival haemorrhage
8%
Diarrhoea
8%
Oral herpes
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%
Cystitis
5%
Hypertension
5%
Flushing
5%
Anxiety
5%
Blood pressure increased
5%
Thermal burn
5%
Neutropenia
5%
Muscle spasms
5%
Hypercholesterolaemia
5%
Myalgia
5%
Blood fibrinogen increased
5%
Bronchitis
5%
Laryngitis
5%
Fall
5%
Ear discomfort
5%
Sinusitis
5%
Rhinorrhoea
5%
Dental caries
5%
Rib fracture
5%
Dyslipidaemia
5%
Blepharitis
5%
Rash
5%
Constipation
5%
Gastritis
5%
Oropharyngeal pain
5%
Pain in extremity
5%
Prothrombin time prolonged
5%
Hypocomplementaemia
5%
Blood fibrinogen decreased
3%
Dizziness
3%
Lymphocyte percentage increased
3%
Vomiting
3%
Influenza
3%
Toothache
3%
Forearm fracture
3%
White blood cell count decreased
3%
Hordeolum
3%
Aspartate aminotransferase increased
3%
Periodontitis
3%
Haemorrhoids
3%
Lymphocyte count decreased
3%
Large intestine infection
3%
Rhinitis
3%
Back pain
3%
White blood cell count increased
3%
Abdominal pain upper
3%
Insomnia
3%
Neuromyelitis optica pseudo relapse
3%
Lumbar spinal stenosis
3%
Blood creatine phosphokinase increased
3%
Tonsillitis
3%
Pharyngitis
3%
Urticaria
3%
Neutrophil count increased
3%
Haemoglobin decreased
3%
Upper limb fracture
3%
Cervical dysplasia
3%
Parkinsonism
3%
Gait disturbance
3%
Neutrophil percentage increased
3%
Spinal compression fracture
3%
Neutrophil count decreased
3%
Non-cardiac chest pain
3%
Hepatitis E
3%
Iron deficiency anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab Open-Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Double Blind Period
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SatralizumabExperimental Treatment1 Intervention
Participants will receive Satralizumab subcutaneous (SC) injection at a dose of 60 mg or 120 mg on Day 1 and Weeks 2 and 4 and then every 4 weeks (Q4W) from Weeks 8 to 104 (maintenance doses) until the study completion visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,077 Total Patients Enrolled