A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
Running, not enrolling · Phase 2
Conditions studied: Duchenne Muscular Dystrophy
In brief
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.
Key facts
- Study ID
- NCT06450639
- Run by
- Hoffmann-La Roche
- People needed
- 30
- Starts
- 2025-04-04
- Expected to finish
- 2026-11-18
- Last updated by the study team
- 2026-05-15
Who can join
Age: 8 and older, up to 17. Sex: male. Healthy volunteers: not accepted.
Where it is running
- 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
- Corewell Health — Grand Rapids, Michigan, 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
- Policlinico Agostino Gemelli — Rome, Lazio, Italy
- Fondazione IRCCS Istituto Neurologico ?Carlo Besta? — Milan, Lombardy, Italy
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
- Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
- Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny — Warsaw, Poland
- Hospital Sant Joan De Deu — Esplugues de Llobregas, Barcelona, Spain
- Hospital U. Central de Asturias — Asturias, Principality of Asturias, Spain
- Hospital Universitario Torrecardenas;Servicio de Neurologia — Almería, Spain
- Hospital Universitario la Fe — Valencia, Spain
- Ivano-Frankivsk Regional Children Clinical Hospital — Ivano-Frankivsk, Kharkiv Governorate, Ukraine
- Ohmatdyt - National Specialized children's hospital of MoH of Ukraine — Kyiv, Ukraine
- Lvivska oblasna tsentralna likarnia — Lviv, Ukraine
Full record on ClinicalTrials.gov
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