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NCT05540860 · ClinicalTrials.gov registry record · Phase 2

A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)

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

Active
Registry status
Phase 2
Development phase
76
Enrollment target
14
Study locations

NCT05540860 is a Phase 2 study of Duchenne Muscular Dystrophy that is active but no longer recruiting, run by Edgewise Therapeutics. The registered enrollment target is 76 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (82% lower). The trial reports 14 study locations across 12 states.

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The verdict

NCT05540860, a Phase 2 study of Duchenne Muscular Dystrophy, is active but no longer recruiting, sponsored by Edgewise Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
76 participants
Enrollment target
14
Study locations

Study Summary

The LYNX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics and biomarkers in children with Duchenne muscular dystrophy including a randomized, double-blind, placebo-controlled part A, followed by an open-label part B.

Interventions

  • DRUG Sevasemten Dose 1
  • DRUG Sevasemten Dose 2
  • DRUG Sevasemten Dose 3
  • DRUG Sevasemten Dose 4
  • DRUG Sevasemten Dose 5

Study Locations (14)

California

  • UCLA Medical Center - Los Angeles
  • UC Davis Medical Center - Sacramento

Ohio

  • Cincinnati Children's Hospital - Cincinnati
  • Nationwide Children's Hospital - Columbus

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • University of Florida - Gainesville

Georgia

  • Rare Disease Research - Atlanta

Iowa

  • University of Iowa - Iowa City

Kansas

  • University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2022-10-24
Est. Completion 2027-01
Phase Phase 2

Sponsor

Edgewise Therapeutics

15 total trials

What the Registry Record Tells You About NCT05540860

The ClinicalTrials.gov registry entry for NCT05540860 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 76 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 (82% lower). The listed sponsor is Edgewise Therapeutics, which has 15 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 5 interventions - of which Sevasemten Dose 1 is the first listed.

NCT05540860 reports 14 study locations spanning 12 distinct geographic areas - top geographies include California, Ohio, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05540860 about?

NCT05540860 is a clinical study titled "A Study of EDG-5506 in Children With Duchenne Muscular Dystrophy (LYNX)". The LYNX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics and biomarkers in children with Duchenne muscular dystrophy including a randomized, double-blind, placebo-controlled part A, followed by an open-label part B.

What is the current status of trial NCT05540860?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2022-10-24. Estimated completion is 2027-01.

What conditions does trial NCT05540860 study?

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

What interventions are being tested in trial NCT05540860?

The interventions under investigation include: Sevasemten Dose 1 (DRUG), Sevasemten Dose 2 (DRUG), Sevasemten Dose 3 (DRUG), Sevasemten Dose 4 (DRUG), Sevasemten Dose 5 (DRUG).

Who is sponsoring clinical trial NCT05540860?

This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05540860 being conducted?

This trial has 14 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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