← 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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 30 months for reporting.

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 more

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884

100%

Rash

100%

Haemorrhoids

100%

White blood cell count decreased

100%

Rhinitis

100%

Localised infection

100%

Hypotension

100%

Lymphocyte percentage decreased

100%

Monocyte count increased

100%

White blood cell count increased

100%

Pruritus

100%

Headache

100%

Diarrhoea

100%

Abdominal pain

100%

Tonsillitis

100%

Dysmenorrhoea

100%

Rectal haemorrhage

100%

Ear infection

100%

Neutrophil count increased

100%

Oropharyngeal pain

100%

Haemoglobin decreased

100%

Neutrophil percentage increased

100%

Platelet count increased

100%

Lymphocyte percentage increased

100%

Neutrophil count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Satralizumab Open-Label Period

Placebo + Baseline Treatment Open Label Period

Satralizumab + Baseline Treatment 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

0 / 13Eligibility criteria met