Only 33 spots left

~33 spots leftby Nov 2026

Satralizumab for Duchenne Muscular Dystrophy
(SHIELD DMD Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: < 18

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Hoffmann-La Roche

Must be taking: Corticosteroids

Disqualifiers: HIV, Tuberculosis, Hepatitis B, others

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial requires participants to be on daily oral corticosteroids, but it does not specify if you need to stop other medications. It's best to discuss your current medications with the trial team to get a clear answer.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

Participants with a prior history of low-trauma fractures are additionally required to meet the following criteria:

I have a confirmed diagnosis of DMD based on genetic testing.

Signed Informed Consent Form and Signed Assent Form when appropriate

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Exclusion Criteria

Has serological evidence of current, chronic, or active human immunodeficiency virus, tuberculosis, hepatitis C, or hepatitis B infection

I haven't had major surgery in the last 3 months and don't plan any that could affect this study.

I have a serious health condition.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive satralizumab SC injection on Day 1, Weeks 2 and 4 (loading doses) and then Q4W from Weeks 8 to 104 (maintenance doses)

104 weeks

In-person visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

Satralizumab (Monoclonal Antibodies)

Trial OverviewThe 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).

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SatralizumabExperimental Treatment1 Intervention

Participants will receive satralizumab SC injection on Day 1, Weeks 2 and 4 (loading doses) and then Q4W from Weeks 8 to 104 (maintenance doses) until the study completion visit.

Satralizumab is already approved in Canada, Japan, Switzerland for the following indications: