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NCT06053814 · ClinicalTrials.gov registry record · Phase 1
NS-050/NCNP-03 in Boys With DMD (Meteor50)
A Phase 1 study of Duchenne Muscular Dystrophy, sponsored by NS Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 18
- Study locations
NCT06053814: Recruiting Phase 1 study of Duchenne Muscular Dystrophy, sponsored by NS Pharma.
NCT06053814 is a Phase 1 study of Duchenne Muscular Dystrophy 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 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06053814, a Phase 1 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by NS Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD exon deletion amenable to exon 50 skipping.
Primary Outcome
TEAEs will be summarized both at the patient level for number of TEAEs, highest severity, relationship, action, and outcome, and at the TEAE level (summarizing events) by system organ class (SOC) and preferred term (PT) as well as severity, relationship, action, and outcome. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) will be used for coding TEAEs.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NS-050/NCNP-03
Study Locations (18)
Other
- Seoul National University Hospital - Seoul
- Ankara Bilkent City Hospital - Ankara
- Istanbul University - Istanbul
- Yeditepe University Kosuyolu Hospital - Istanbul
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Alberta
- Alberta Children's Hospital - Calgary
British Columbia
- British Columbia Children's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT06053814 shows while recruiting
NCT06053814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06053814 lists 18 locations in 14 states (Other, Pennsylvania, California).
Frequently Asked Questions
What is clinical trial NCT06053814 about?
NCT06053814 is a clinical study titled "NS-050/NCNP-03 in Boys With DMD (Meteor50)". This is a Phase 1/2 study of Multiple-Ascending Dose (MAD) levels for 12 weeks of treatment followed by 24 weeks of open-label treatment with a selected dose of NS-050/NCNP-03 administered once weekly to ambulant boys with DMD, who have a DMD exon deletion amenable to exon 50 skipping.
What is the current status of trial NCT06053814?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-09-18. Estimated completion is 2027-05.
What conditions does trial NCT06053814 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT06053814?
The interventions under investigation include: Placebo (DRUG), NS-050/NCNP-03 (DRUG).
Who is sponsoring clinical trial NCT06053814?
This trial is sponsored by NS Pharma, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06053814 being conducted?
This trial has 18 study locations across California, Colorado, Illinois, Kansas, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06053814's enrollment target sits among peer trials
20 36th of 48 higher than 12 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of SGT-003 Gene Therapy in Duchenne Muscular Dystrophy (INSPIRE DUCHENNE)
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Study of AOC 1044 in Healthy Adult Volunteers and Participants With Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping
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