NCT06450639 · ClinicalTrials.gov record · last posted 2026-08-13
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
Study acronym: SHIELD DMD
StatusActive, Not Recruiting
PhasePhase 2
Started2025-04-04
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 13, 2026 (before its estimated August 26, 2026 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.
Protocol amendment history
7 changes detected by DataLookout
2026-05-16
critical
Primary endpoint(s) modified
WasGroup 2: Change From Baseline to Week 52 in Lumbar Spine (LS) Bone Mineral Density (BMD) Z-score Measured by Dual-energy X-ray Absorptiometry (DEXA)
NowGroup 2: Change From Baseline to Week 24 in Lumbar Spine (LS) Bone Mineral Density (BMD) Z-score Measured by Dual-energy X-ray Absorptiometry (DEXA)
2026-05-16
minor
Trial sites reduced: 22 → 19 locations
2026-04-10
notable
Trial status changed: Recruiting → Active, Not Recruiting
2026-04-10
critical
Enrollment reduced: 50 → 30 participants
2026-04-10
minor
Trial sites reduced: 25 → 22 locations
2026-04-10
minor
Primary completion moved earlier: 2026-09-30 → 2026-08-26
2026-04-10
minor
Completion moved earlier: 2028-06-30 → 2026-11-18
| NCT Number |
NCT06450639 |
| Lead Sponsor |
Hoffmann-La Roche
|
| Conditions |
Duchenne Muscular Dystrophy |
| Enrollment |
30 participants |
| Start Date |
2025-04-04 |
| Primary Completion |
2026-08-26 (estimated) |
| Study Completion |
2026-11-18 (estimated) |
| Updated on ClinicalTrials.gov |
2026-08-13 |