🏛️ Verified NIH Record • Updated 2026-08-12

A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) (NCT06450639)

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)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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 aged ≥ 8 to \< 18 years old receiving corticosteroid therapy.

Who can join: Review the eligibility criteria below.

Location: Arkansas Children's Hospital — Little Rock, Arkansas

Age range: 8 Years to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (18 Sites)

  • Arkansas Children's Hospital — Little Rock, Arkansas
  • University of California Davis Medical Center — Sacramento, California
  • Children's Healthcare of Atlanta Center for Advanced Pediatrics — Atlanta, Georgia
  • Corewell Health — Grand Rapids, Michigan
  • Neurology Rare Disease Center — Flower Mound, Texas
  • Child's Hosp King's Daughters — Norfolk, Virginia
  • Rigshospitalet;Klinik for Børn og Unge med Hjerne- og Nervesygdomme — København Ø,
  • Policlinico Agostino Gemelli — Rome, Lazio
  • Fondazione IRCCS Istituto Neurologico ?Carlo Besta? — Milan, Lombardy
  • Uniwersyteckie Centrum Kliniczne — Gdansk,
  • Instytut Centrum Zdrowia Matki Polki — Lodz,
  • Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny — Warsaw,
  • Hospital Sant Joan De Deu — Esplugues de Llobregas, Barcelona
  • Hospital U. Central de Asturias — Asturias, Principality of Asturias
  • Hospital Universitario Torrecardenas;Servicio de Neurologia — Almería,
  • Hospital Universitario la Fe — Valencia,
  • Ohmatdyt - National Specialized children's hospital of MoH of Ukraine — Kyiv,
  • Lvivska oblasna tsentralna likarnia — Lviv,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗