NCT06100887 (FOX) is a Phase 2 clinical trial of Sevasemten Dose 1 in Duchenne Muscular Dystrophy, sponsored by Edgewise Therapeutics, Inc..

Who is sponsoring NCT06100887?

NCT06100887 is sponsored by Edgewise Therapeutics, Inc..

What drugs are being tested in NCT06100887?

Interventions in NCT06100887: Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Placebo.

What condition does NCT06100887 study?

NCT06100887 studies Duchenne Muscular Dystrophy.

Is NCT06100887 still recruiting?

NCT06100887 is currently active, enrolled. Last updated 5 November 2025.

Last reviewed 2025-11-05 · How we verify

NCT06100887: FOX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Study to Evaluate the Effect of EDG-5506 on Safety, Pharmacokinetics, and Biomarkers in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Active, enrolled Phase 2 Last updated 5 November 2025

What this trial tests

Phase 2 trial testing Sevasemten Dose 1 in Duchenne Muscular Dystrophy in 43 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 March 2024

Primary endpoint
1 March 2027

1 March 2027

Quick facts

Lead sponsor	Edgewise Therapeutics, Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	43
Start date	22 March 2024
Primary completion	1 March 2027
Estimated completion	1 March 2027
Sites	7 locations across United States

Drugs / interventions tested

Sevasemten Dose 1 — full drug profile →
Sevasemten Dose 2
Sevasemten Dose 3
Placebo

Conditions studied

Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →

Sponsor

Edgewise Therapeutics, Inc. — full company profile →

Who can join

Adults 6 to 17, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of adverse events during treatment with sevasemten or placebo
Time frame: 36 months
All participants
Severity of adverse events during treatment with sevasemten or placebo
Time frame: 36 months
All participants

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular mechanisms and therapeutic strategies for neuromuscular diseases.
Zambon AA, Falzone YM, Bolino A, Previtali SC. · · 2024 · cited 7× · PMID 38678519 · DOI 10.1007/s00018-024-05229-9
Molecular pathways involved in the control of contractile and metabolic properties of skeletal muscle fibers as potential therapeutic targets for Duchenne muscular dystrophy.
Bonato A, Raparelli G, Caruso M. · · 2024 · cited 4× · PMID 39717824 · DOI 10.3389/fphys.2024.1496870
A Phase 1, Double-Blind, Placebo-Controlled Trial of Sevasemten (EDG-5506), a Selective Modulator of Fast Skeletal Muscle Contraction, in Healthy Volunteers and Adults With Becker Muscular Dystrophy.
Donovan J, Silverman JA, Barthel B, DuVall M, et al · · 2025 · cited 2× · PMID 40452637 · DOI 10.1002/mus.28444

Verify or expand the search:

Other recruiting trials for Duchenne Muscular Dystrophy

Currently open trials in the same condition.

NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting

Other Edgewise Therapeutics, Inc. trials

Trials by the same sponsor.

NCT07034768 — A Study to Evaluate EDG-7500 in People With Renal Impairment · Phase 1 · completed
NCT06916897 — A Study to Evaluate Effect of Verapamil and Food of Sevasemten in Healthy Volunteers · Phase 1 · completed
NCT06738836 — A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500 · Phase 1 · completed
NCT06011317 — A Study of EDG-7500 in Healthy Adults · Phase 1 · completed
NCT05730842 — Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06100887 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edgewise Therapeutics, Inc.
Last refreshed: 5 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06100887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing