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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 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.

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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.

Conditions Studied

Duchenne Muscular Dystrophy

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

FieldValue
Enrollment Target 50 participants
Start Date 2025-04-04
Est. Completion 2028-06-30
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06450639

The ClinicalTrials.gov registry entry for NCT06450639 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (88% lower). The listed sponsor is Hoffmann-La Roche, which has 909 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 Satralizumab is the first listed.

NCT06450639 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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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.