Could an arthritis drug help kids with duchenne MD? new trial aims to find out
NCT ID NCT06450639
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This study tests satralizumab, a drug that calms inflammation, in 30 children aged 8 to 17 with Duchenne muscular dystrophy. The goal is to see if it improves bone density and muscle function. Participants receive injections for several months while continuing standard steroid therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- satralizumab (a drug that targets inflammation)
- What this could lead to
- If successful, this could point toward a new treatment to strengthen bones and slow muscle decline in children with Duchenne muscular dystrophy.
- What could go wrong
- This is an early Phase 2 study with only 30 participants, so results may not apply to all patients. The drug may not improve bone density or muscle function as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Apr 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 17 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Signed Informed Consent Form (ICF) and signed Assent Form when appropriate * Male at birth * 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 * Age ≥ 8 and \< 18 years at the time of signing ICF * Group 1 participants are required to meet the following criteria: - Ambulatory (defined as able to walk independently without assistive devices) with a prior history of fractures: a) 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 vertebral fractures \[VF\]) or history of at least one low-trauma long-bone fracture (upper or lower extremity) or b) 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 North Star Ambulatory Assessment (NSAA) walk score of "0" and inability to perform the 10-Meter Walk/Run (10 MWR) at the baseline visit, with or without fractures * 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 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 * Daily oral corticosteroids Key Exclusion Criteria: * 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 * Has serological evidence of current, chronic, or active human immunodeficiency virus (HIV), tuberculosis (TB), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection * Has a symptomatic infection (e.g., upper respiratory tract infection, pneumonia, pyelonephritis, meningitis) within 4 weeks prior to baseline * Body weight at screening \< 20 or \> 100 kilograms (kg) * Evidence of a severe VF (defined as Grade 3), assessed by radiographic imaging at screening and quantified using the Genant semiquantitative method * Treatment with prohibited therapies as defined by the protocol * Has received a live or live attenuated virus vaccine within 6 weeks of the baseline visit or expects to receive a live or live attenuated virus vaccine during the study * Has abnormal laboratory values considered clinically significant as defined by the protocol * Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion * Participant has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety, make it unlikely that treatment and follow-up will be correctly completed or impair the assessment of study results, in the opinion of the investigator * Participant has an allergy or hypersensitivity to the study medication or to any of its constituents. Other protocol defined inclusion and exclusion criteria may apply
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
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Child's Hosp King's Daughters
Norfolk, Virginia, 23507, United States
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Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, 30329, United States
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Corewell Health
Grand Rapids, Michigan, 49503, United States
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Fondazione IRCCS Istituto Neurologico ?Carlo Besta?
Milan, Lombardy, 20133, Italy
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Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, 08950, Spain
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Hospital U. Central de Asturias
Asturias, Principality of Asturias, 33011, Spain
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Hospital Universitario Torrecardenas;Servicio de Neurologia
Almería, 04009, Spain
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Hospital Universitario la Fe
Valencia, 46026, Spain
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Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
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Lvivska oblasna tsentralna likarnia
Lviv, 79010, Ukraine
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Neurology Rare Disease Center
Flower Mound, Texas, 75028, United States
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Ohmatdyt - National Specialized children's hospital of MoH of Ukraine
Kyiv, 01135, Ukraine
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Policlinico Agostino Gemelli
Rome, Lazio, 00168, Italy
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Rigshospitalet;Klinik for Børn og Unge med Hjerne- og Nervesygdomme
København Ø, 2100, Denmark
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University of California Davis Medical Center
Sacramento, California, 95817, United States
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Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
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Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
Warsaw, 02-097, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new dosing schedule tame steroid side effects in duchenne?
- Can a daily supplement ease the toll of duchenne muscular dystrophy?
- Can a lower steroid dose preserve strength in young boys with DMD?
- Can a targeted infusion slow muscle decline in duchenne? a new trial aims to find out.
- Can a massive patient database unlock new treatments for muscular dystrophy?
- Umbilical cord stem cells aim to slow muscle loss in duchenne boys