BridgeMD
A study to check the effect of satralizumab in children and adolescents living with Duchenne muscular dystrophy, to check if it is safe and also how it affects the different parts of the body and how it is eliminated from the body (SHIELD DMD)
EU CTIS ID: 2024-512383-65-00
What this study is testing
To evaluate the efficacy of satralizumab in bone mineral density (BMD) as assessed by dual-energy X-ray absorptiometry (DEXA) in fracture-naïve participants
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 8 and < 18 years at the time of signing Informed Consent Form
- Male at birth
- Group 2 participants are required to meet the following criteria: Be fracture naïve, defined as: No history of prior low-trauma fractures before the baseline visit nor any radiological findings indicative of prevalent vertebral fracture (VF) at the screening visit – Be ambulatory, defined as able to walk independently without assistive devices. – Age ≥ 8 to < 12 years old at the time of screening
- Group 1 participants are required to meet the following criteria: – SDI ≤ 3 - Age ≥ 8 to < 18 years old at the time of screening – If ambulatory (defined as able to walk independently without assistive devices) the participant must have a prior history of fractures Prior history of low-trauma fracture defined as: evidence of at least one prevalent vertebral compression fracture of Genant Grade 1 or 2 (or radiographic signs of VF) or history of at least one low-trauma long bone fracture (upper or lower extremity) but no more than two events incurring in low-trauma fractures (at any anatomical site) OR – If non-ambulatory, characterized as being non-ambulatory for a minimum of 6 months with onset of non-ambulatory status defined as participant- or caregiver-reported age of continuous wheelchair use, approximated to the nearest month, and an NSAA walk score of "0" and inability to perform the 10MWR at the baseline visit, the participant can be with or without prevalent fractures at baseline
- For ambulatory participants: Group 1 and 2: NSAA total score ≥ 16 as assessed at the screening visit
- Daily oral corticosteroids for at least 12 months with a stable dose for at least 12 weeks prior to screening and the dose is expected to remain constant (except for modifications to accommodate changes in weight) throughout the study
You likely can't join if
- 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, including cardiac, pulmonary, hepatic, renal, hematologic, immunologic, or behavioral disease, or infection or malignancy or concomitant illness or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risks for the participant or a medical condition or extenuating circumstance that, in the opinion of the Investigator, might compromise the subject’s ability to comply with the protocol required testing or procedures or compromise the subject’s wellbeing, safety, or clinical interpretability
- Has serological evidence of current, chronic, or active human immunodeficiency virus, hepatitis C, or hepatitis B infection
- Has a symptomatic infection (e.g. upper respiratory tract infection, pneumonia, pyelonephritis, meningitis) within 4 weeks prior to baseline
- History or laboratory evidence of coagulation disorders
- Body weight at screening < 20 or > 100 kg
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.