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RECRUITINGPHASE2

A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)

A Phase II Multicenter, Open-label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Pediatric Patients With Duchenne Muscular Dystrophy (SHIELD DMD)

NCT06450639•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory participants with DMD age ≥ 8 to \< 18 years old receiving corticosteroid therapy.

Detailed Description

Participants will be included in two groups: ambulatory participants with fractures and non-ambulatory participants with or without a history of fractures (Group 1) and ambulatory participants who are fracture naive (Group 2) at baseline. The study will assess the potential of satralizumab to improve bone fragility and to increase muscle function. A weight tier based dose of satralizumab will be given by subcutaneous (SC) injection every 4 weeks (Q4W).

Eligibility

Age

8 - 17 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Signed Informed Consent Form 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 Informed Consent Form
•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:
•1. 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) OR
•2. 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
+3 more criteria

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, or hepatitis B 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 kg
•Evidence of a severe vertebral fracture (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 vaccination during the first 3 months after Baseline.
•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.
+2 more criteria

Locations (25)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of California Davis Medical Center

Sacramento, California, United States

Children's Healthcare of Atlanta Center for Advanced Pediatrics

Atlanta, Georgia, United States

University of Massachusetts Memorial Childrens Medical Center

Worcester, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Billings Clinic Research Center

Billings, Montana, United States

Columbia University Medical Center

New York, New York, United States

Neurology Rare Disease Center

Flower Mound, Texas, United States

Child's Hosp King's Daughters

Norfolk, Virginia, United States

Rigshospitalet;Klinik for Børn og Unge med Hjerne- og Nervesygdomme

København Ø, Denmark

Key Dates

Start Date

April 4, 2025

Primary Completion Date

September 30, 2026

Completion Date

June 30, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Duchenne Muscular Dystrophy

Interventions

Satralizumab

DRUG

Contacts

Reference Study ID Number: BN45398 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Global Medical Information:

CONTACT

global-roche-genentech-trials@gene.com

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

NCT07037862

Duchenne Muscular Dystrophy (DMD)

View study

RECRUITINGPHASE3

A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

NCT07160634

Duchenne Muscular Dystrophy

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RECRUITINGNA

Fear of Falling in Muscular Dystrophy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)

Inclusion Criteria

Exclusion Criteria

A Study in Participants With Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44

A Study of SGT-003 Gene Therapy in Ambulant Males With Duchenne Muscular Dystrophy (IMPACT DUCHENNE)

Fear of Falling in Muscular Dystrophy

Vasodilator and Exercise Study for DMD (VASO-REx)

DMD Voice: Qualitative Interviews With Patients and Caregivers

Evaluation of the Safety, Tolerability, and Efficacy of LE051 in Patients With Duchenne Muscular Dystrophy