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Monoclonal Antibodies

Satralizumab for Muscular Dystrophy (REINFORCE Trial)

Phase 2

Recruiting

Research Sponsored by Centre Hospitalier Universitaire de Nice

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent

Male or female subjects between the ages of 18 and 65 years, inclusive

Must not have

Subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study

Orthopedic conditions, such as unresolved fracture or arthrosis, interfering or precluding testing of muscle function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 96

Summary

This trial is studying a type of muscle disease called facioscapulohumeral muscular dystrophy (FSHD), which is caused by a gene mutation leading to muscle cell death and weakness. Recent

Who is the study for?

This trial is for adults with FSHD1, a type of muscular dystrophy. Participants should have evidence of muscle weakness and meet specific clinical criteria. Those with other forms of muscular dystrophy or conditions that might interfere with the study are excluded.

What is being tested?

The study tests Satralizumab, an IL-6 receptor blocker thought to reduce inflammation in muscles affected by FSHD1. It's compared against a placebo in a randomized, double-blind setup to assess its effectiveness and safety.

What are the potential side effects?

Satralizumab may cause potential side effects such as infections due to immune system suppression, liver issues, increased cholesterol levels, gastrointestinal problems, and hypersensitivity reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and have signed the consent form for the trial.

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I am between 18 and 65 years old.

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My body weight is 100 kg or less.

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My MRI shows significant fat in my muscles but not over 50%.

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I can walk on my own without any help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've been on a stable dose of medication or supplements that affect muscle function for at least 3 months.

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I have bone or joint issues that could affect muscle testing.

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I cannot have an MRI due to medical reasons.

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I have had or will have surgery that limits my joint movement.

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I am legally able to participate in a clinical study.

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I haven't had any cancer except for certain skin cancers or treated cervical cancer in the last 5 years.

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My kidney function is severely impaired.

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I have a history of liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during the Double Blind (DB) period (week 0 to week 48) on FSHD-Composite Outcome Measure (FSHD-COM) total score, sub-scale scores and individual items.

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during the Double Blind (DB) period (week 0 to week 48) on FSHD-Rasch-built overall disability scale (FSHD-RODS) total score

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during the Double Blind (DB) period (week 0 to week 48) on Neuromuscular Disease Independence Scale-Ambulatory (NMDIS-Amb) total score.

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Secondary study objectives

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during Double Blind (DB) and Open-label (OL) periods (week 0 to week 96) on FSHD-Rasch-built overall disability scale (FSHD-RODS) total score

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during Double Blind (DB) and Open-label (OL) periods (week 0 to week 96) on Neuromuscular Disease Independence Scale-Ambulatory (NMDIS-Amb) total score

The study will evaluate the efficacy of satralizumab compared to placebo, measured by the change during Double Blind (DB) and Open-label (OL) periods (week 0 to week 96) on RICCI clinical severity scale score

+6 more