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A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
NCT06450639 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Satralizumab
Study Locations (20)
Other
- Rigshospitalet;Klinik for Børn og Unge med Hjerne- og Nervesygdomme — København Ø
- Uniwersyteckie Centrum Kliniczne — Gdansk
- Instytut Centrum Zdrowia Matki Polki — Lodz
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
- Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny — Warsaw
- Hospital Universitario Torrecardenas;Servicio de Neurologia — Almería
Arkansas
- Arkansas Children's Hospital — Little Rock
California
- University of California Davis Medical Center — Sacramento
Georgia
- Children's Healthcare of Atlanta Center for Advanced Pediatrics — Atlanta
Massachusetts
- University of Massachusetts Memorial Childrens Medical Center — Worcester
Michigan
- Corewell Health — Grand Rapids
Montana
- Billings Clinic Research Center — Billings
New York
- Columbia University Medical Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06450639
The ClinicalTrials.gov registry entry for NCT06450639 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention — of which Satralizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06450639 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06450639 about?
NCT06450639 is a clinical study titled "A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)". 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 corticostero...
What is the current status of trial NCT06450639?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2025-04-04. Estimated completion is 2028-06-30.
What conditions does trial NCT06450639 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06450639?
The interventions under investigation include: Satralizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06450639?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06450639 being conducted?
This trial has 20 study locations across Arkansas, California, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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