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NCT04428476 · ClinicalTrials.gov registry record · Phase 2

Open-label Extension of the HOPE-2 Trial

A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Capricor.

Active
Registry status
Phase 2
Development phase
13
Enrollment target
5
Study locations

NCT04428476 is a Phase 2 study of Duchenne Muscular Dystrophy that is active but no longer recruiting, run by Capricor. The registered enrollment target is 13 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT04428476, a Phase 2 study of Duchenne Muscular Dystrophy, is active but no longer recruiting, sponsored by Capricor.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
13 participants
Enrollment target
5
Study locations

Study Summary

This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of twenty intravenous administrations of deramiocel, each separated by three months, over a period of approximately 60 months. Following completion of the initial open-label phase (Month 60), subjects who have completed all Month 60 assessments will be eligible to continue into a long-term open label extension (LT-OLE) period and can continue to receive deramiocel once every 3 months until deramiocel is commercially available or the sponsor terminates the study, or the subject withdraws consent or study participation is terminated by the sponsor. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of deramiocel. Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, and all LT-OLE visits. Safety and efficacy assessments will be conducted prior to deramiocel administration at the Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, and at all LT-OLE trial visits, unless otherwise indicated. All deramiocel infusions will be conducted in an outpatient setting at the investigative site on Day 1 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, with continued dosing in the LT-OLE visits. Subjects will be observed in the outpatient setting for at least two hours post infusion and then discharged the same day, if medically cleared by the site Investigator.

Conditions Studied

Duchenne Muscular Dystrophy

Interventions

  • BIOLOGICAL Deramiocel (CAP-1002)

Study Locations (5)

California

  • University of California, Davis - Sacramento

Colorado

  • Children's Hospital Colorado - Aurora

Missouri

  • Washington University - St Louis

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Wisconsin

  • Children's Hospital Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2020-08-05
Est. Completion 2026-05
Phase Phase 2

Sponsor

Capricor

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04428476

The ClinicalTrials.gov registry entry for NCT04428476 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (97% lower). The listed sponsor is Capricor, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Deramiocel (CAP-1002) is the first listed.

NCT04428476 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Missouri.

Frequently Asked Questions

What is clinical trial NCT04428476 about?

NCT04428476 is a clinical study titled "Open-label Extension of the HOPE-2 Trial". This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of twenty intravenous administrations of deramiocel, each separated by thr...

What is the current status of trial NCT04428476?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2020-08-05. Estimated completion is 2026-05.

What conditions does trial NCT04428476 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT04428476?

The interventions under investigation include: Deramiocel (CAP-1002) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04428476?

This trial is sponsored by Capricor, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04428476 being conducted?

This trial has 5 study locations across California, Colorado, Missouri, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.