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HOPE-3NCT05126758

A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy

StatusActive, Not Recruiting
PhasePhase 3
Primary completion
Track this trial

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Record History

All 20 versions: 19 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 33 words Show 6 more changesShow less
    • Interventions modified
    • Trial arms changed: 2 → 5
    • Secondary endpoints: details revised at 2 of 10 entries
    • Study description revised
    • Site details revised at 13 of 20 sites
    • Publications: details revised at 1 of 1 entry
  2. Study completion pushed from Dec 2026 to Mar 2027v19
  3. Enrollment target: 104 to 106
    • Primary completion date changed from estimate of Dec 2025 to Jun 18, 2025
    • Study completion date: Dec 2027 to Dec 2026
    • Secondary endpoints revised (10)
    v17
  4. Study sites: 21 to 20
    • Secondary endpoints reordered
    v16
  5. Primary completion date: Dec 2024 to Dec 2025v15 Show 9 more changesShow less
    • Eligibility criteria revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 102 to confirmed 104
    • Study completion date: Dec 2026 to Dec 2027
    • Interventions: CAP-1002 (Biological), Placebo (Biological) to Deramiocel (CAP-1002) (Biological), Placebo (Biological)
    • Secondary endpoints revised (10)
    • Study description expanded, about 23 words
    • Site details revised at 21 of 21 sites
    • Study title expanded, about 1 word
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 21 sitesv14
  2. Study sites: 20 to 21v13
  3. Study sites: 19 to 20v12
  4. Study sites: 17 to 19v11
  5. Enrollment target: 68 to 102v10 Show 6 more changesShow less
    • Eligibility criteria expanded, about 322 words
    • Primary endpoint revised
    • Study sites: 16 to 17
    • Study completion date: Dec 2025 to Dec 2026
    • Interventions: CAP-1002 (Biological), Placebo (Drug) to CAP-1002 (Biological), Placebo (Biological)
    • Study description expanded, about 125 words
  6. Study sites: 13 to 16v9
  7. Eligibility criteria expanded, about 31 words
    • Study sites: 10 to 13
    v8
  8. Eligibility criteria expanded, about 30 words
    • Study sites: 8 to 10
    • Secondary endpoints: 9 to 10
    • Study description shortened, about 2 words
    v7
  9. Study sites: 5 to 8
    • Study description expanded, about 1 word
    v6
  10. Study sites: 3 to 5
    • Start date changed from estimate of May 2022 to Jun 22, 2022
    • Study title shortened, about 1 word
    v5
  11. Trial status: Not Yet Recruiting to Recruitingv4 Show 8 more changesShow less
    • Primary completion date: Jun 30, 2023 to Dec 2024
    • Start date: Mar 15, 2022 to May 2022
    • Eligibility criteria expanded, about 365 words
    • Primary endpoint revised
    • Study sites: 1 to 3
    • Study completion date: Jun 30, 2024 to Dec 2025
    • Secondary endpoints: 1 to 9
    • Study description expanded, about 113 words
  12. Site contact updatedv3
  13. Start date: Jan 1, 2022 to Mar 15, 2022
    • Site contact updated
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in the upper limb function
Timeframe: At Month 12

Secondary (10)

Change in cardiac muscle function and structure by assessment of left ventricular ejection fraction
Change in mid-level (elbow) upper limb function
Change in Global Statistical Test (Total GST) combining upper limb function, cardiac muscle function, and patient reported measure of disease severity
Change in the number of segments of myocardial scarring (Cohort B only)
Change in cardiac muscle function and structure by assessment of left ventricular end-systolic volume
Show 5 moreShow less
Change in cardiac muscle function and structure by assessment of left ventricular ejection fraction in subjects with documented cardiomyopathy
Change in a global statistical test (Cardiac GST) combining assessments of cardiac muscle function and structure
Change in percentage of myocardial scarring (Cohort B only)
Change in hand-to-mouth function in the context of functional eating
Changes in cardiac inflammation biomarker, creatine kinase MB isoenzyme [CK-MB]

Arms and interventions

Deramiocel (CAP-1002) Cohort AExperimental

Cohort A: Approximatetly 29 subjects will receive deramiocel (CAP-1002A) active treatment consisting of 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 infusions through Month 12 of the study

Placebo Cohort APlacebo comparator

Cohort A: Approximately 29 subjects will receive a Placebo solution via intravenous infusion every 3 months for a total of 4 infusions through Month 12 of the study

Deramiocel (CAP-1002) Cohort BExperimental

Cohort B: Approximately 22 participants will receive deramiocel (CAP-1002B) active treatment consisting of 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 infusions through Month 12 of the study

Placebo Cohort BPlacebo comparator

Cohort B: Approximately 22 participants will receive a Placebo solution via intravenous infusion every 3 months for a total of 4 infusions through Month 12 of the study

Deramiocel (CAP-1002) Open Label ExtensionExperimental

Open-Label Extension: After completion of the double-blind, placebo-controlled phase, subjects will receive deramiocel (CAP-1002) active treatment consisting of 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for an additional 12 months followed by the long-term open label extension phase which continues deramiocel administration every 3 months until sponsor decision.

Biologicals: Deramiocel, Placebo

Diagnostic tests: Cardiac magnetic resonance imaging, Cardiac magnetic resonance imaging with contrast

Sites

20 sites in 1 country