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NCT06450639 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06450639: Recruiting Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Hoffmann-La Roche.
NCT06450639 is a Phase 2 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 50 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450639, a Phase 2 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory participants with DMD age ≥ 8 to \< 18 years old receiving corticosteroid therapy.
Primary Outcome
BMD of the LS is measured using DEXA.
Conditions Studied
Interventions
- DRUG Satralizumab
Study Locations (20)
Other
- Rigshospitalet;Klinik for Børn og Unge med Hjerne- og Nervesygdomme - København Ø
- Uniwersyteckie Centrum Kliniczne - Gdansk
- Instytut Centrum Zdrowia Matki Polki - Lodz
- Uniwersytecki Szpital Kliniczny w Poznaniu - Poznan
- Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny - Warsaw
- Hospital Universitario Torrecardenas;Servicio de Neurologia - Almería
Arkansas
- Arkansas Children's Hospital - Little Rock
California
- University of California Davis Medical Center - Sacramento
Georgia
- Children's Healthcare of Atlanta Center for Advanced Pediatrics - Atlanta
Massachusetts
- University of Massachusetts Memorial Childrens Medical Center - Worcester
Michigan
- Corewell Health - Grand Rapids
Montana
- Billings Clinic Research Center - Billings
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-04-04 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT06450639 shows while recruiting
NCT06450639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Satralizumab is the first listed.
NCT06450639 names 20 study sites across 15 states, led by Other, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT06450639 about?
NCT06450639 is a clinical study titled "A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)". The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory participants with DMD age ≥ 8 to \< 18 years old receiving corticostero...
What is the current status of trial NCT06450639?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2025-04-04. Estimated completion is 2028-06-30.
What conditions does trial NCT06450639 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT06450639?
The interventions under investigation include: Satralizumab (DRUG).
Who is sponsoring clinical trial NCT06450639?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450639 being conducted?
This trial has 20 study locations across Arkansas, California, Georgia, Massachusetts, Michigan. 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 NCT06450639's enrollment target sits among peer trials
50 25th of 48 higher than 22 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
-
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
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A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)
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