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SHIELD DMDNCT06450639

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

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from Roche/Genentech

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Record History

All 29 versions: 23 with changes below, 6 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 26, 2026 to Nov 18, 2026v29
  2. Study sites: 19 to 18v28
  3. Primary endpoint(s) modifiedv27 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Trial sites reduced: 22 → 19 locations
    • Secondary endpoints: 16 to 11
    • Study description shortened, about 3 words
  4. Enrollment reduced: 50 → 30 participantsv26 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 25 → 22 locations
    • Primary completion moved earlier from Sep 30, 2026 to Aug 26, 2026
    • Study completion moved earlier from Jun 30, 2028 to Nov 18, 2026
  5. Site details revised at 7 of 25 sitesv25
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 5 of 25 sitesv24
  2. Study sites: 22 to 25v23
  3. Study sites: 19 to 22v22
  4. Study sites: 28 to 19
    • Primary completion date: Nov 30, 2026 to Sep 30, 2026
    • Study completion date: Nov 15, 2027 to Jun 30, 2028
    v21
  5. Study sites: 18 to 28v20
  6. Study sites: 17 to 18v18
  7. Study sites: 16 to 17v16
  8. Study sites: 15 to 16v15
  9. Study sites: 14 to 15v14
  10. Site details revised at 3 of 14 sitesv13
  11. Study sites: 12 to 14
    • Start date changed from estimate of Mar 31, 2025 to Apr 4, 2025
    v12
  12. Start date: Feb 15, 2025 to Mar 31, 2025v11
  13. Study sites: 10 to 12v10
  14. Start date: Nov 29, 2024 to Feb 15, 2025v9 Show 8 more changesShow less
    • Eligibility criteria expanded, about 91 words
    • Primary endpoint revised
    • Study sites: 4 to 10
    • Primary completion date: Jun 30, 2026 to Nov 30, 2026
    • Study completion date: Jun 30, 2027 to Nov 15, 2027
    • Secondary endpoints: 14 to 16
    • Study description expanded, about 15 words
    • Study title revised
  15. Start date: Oct 31, 2024 to Nov 29, 2024v7
  16. Study sites: 1 to 4v6
  17. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 30, 2024 to Oct 31, 2024
    • Study site revised
    v5
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Group 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)
Timeframe: Baseline up to Week 24

Secondary (11)

All Participants: Change From Baseline to Week 24 in LS BMD Z-score Measured by DEXA
Group 2: Change From Baseline to Week 24 in Total Body Less Head (TBLH) BMD Z-score Measured by DEXA
Group 2: Change From Baseline to Week 24 in Total Hip BMD Z-score Measured by DEXA
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants With Serious Adverse Events (SAEs)
Show 6 moreShow less
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Observed Serum Concentration of Satralizumab at Specified Trough Timepoints up to Study End
Apparent Clearance (CL) of Satralizumab
Apparent Volume of Distribution (Vd) of Satralizumab
Area Under the Concentration-time Curve (AUC) of Satralizumab
Percentage of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study

Arms and interventions

SatralizumabExperimental

Satralizumab will be administered SC in the abdominal or femoral region on Day 1, Weeks 2 and 4 (loading doses) and then Q4W from Weeks 8 until the study completion (maintenance doses).

Drugs: Satralizumab

Sites

18 sites in 6 countries

United States 6, Spain 4, Poland 3, Italy 2, Ukraine 2, Denmark 1