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NCT05996003 · ClinicalTrials.gov registry record · Phase 2

NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

A Phase 2 study of Duchenne Muscular Dystrophy and DMD, sponsored by NS Pharma.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
20
Study locations

NCT05996003 is a Phase 2 study of Duchenne Muscular Dystrophy and DMD that is actively recruiting participants, run by NS Pharma. The registered enrollment target is 20 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 19 states.

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The verdict

NCT05996003, a Phase 2 study of Duchenne Muscular Dystrophy and DMD, is actively recruiting participants, sponsored by NS Pharma.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \<15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.

Conditions Studied

Duchenne Muscular Dystrophy DMD Exon 44

Interventions

  • DRUG NS-089/NCNP-02

Study Locations (20)

Pennsylvania

  • The Children's Hospital of Philadelphia (CHOP) - Philadelphia
  • University of Pittsburgh School of Medicine - Pittsburgh

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • Rare Disease Research, LLC - FL - Kissimmee

Georgia

  • Rare Disease Research - Atlanta

Illinois

  • Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago

Kansas

  • University of Kansas Medical Center (KUMC) - Kansas City

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Texas

  • UT Southwestern/Children's Health - Dallas

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-02-22
Est. Completion 2026-09-11
Phase Phase 2

Sponsor

NS Pharma

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05996003

The ClinicalTrials.gov registry entry for NCT05996003 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 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 (95% lower). The listed sponsor is NS Pharma, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which NS-089/NCNP-02 is the first listed.

NCT05996003 reports 20 study locations spanning 19 distinct geographic areas - top geographies include Pennsylvania, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT05996003 about?

NCT05996003 is a clinical study titled "NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)". This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \<15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The stu...

What is the current status of trial NCT05996003?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-02-22. Estimated completion is 2026-09-11.

What conditions does trial NCT05996003 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy, DMD, Exon 44.

What interventions are being tested in trial NCT05996003?

The interventions under investigation include: NS-089/NCNP-02 (DRUG).

Who is sponsoring clinical trial NCT05996003?

This trial is sponsored by NS Pharma, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05996003 being conducted?

This trial has 20 study locations across Colorado, Florida, Georgia, Illinois, Kansas. 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.