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EDG-5506 for Becker Muscular Dystrophy (ARCH Trial)

Phase 1

Waitlist Available

Research Sponsored by Edgewise Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight ≥ 50 kg at the Screening visit

Documented dystrophin mutation with phenotype consistent with BMD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 months

Awards & highlights

ARCH Trial Summary

This trial is testing the safety and pharmacokinetics of EDG-5506 in people with Becker muscular dystrophy.

Who is the study for?

This trial is for adult males aged 18-55 with Becker Muscular Dystrophy who can walk at least 100 meters. They must have completed a prior EDG-5506 study, weigh over 50 kg, and have a BMI of 20-34 kg/m2. Those on recent investigational drugs, with certain medical conditions or taking high doses of corticosteroids are excluded.Check my eligibility

What is being tested?

The ARCH study is testing EDG-5506 in adults with Becker muscular dystrophy to see if it's safe and how the body processes it. It aims to protect and improve muscle function in patients by administering this experimental drug in an open-label, single-center Phase 1b setting.See study design

What are the potential side effects?

As EDG-5506 is investigational, specific side effects aren't listed but generally may include reactions at the site of administration, potential muscle-related symptoms or changes in liver enzymes as commonly seen with new muscular treatments.

ARCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 50 kg.

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I have a confirmed genetic mutation for Becker muscular dystrophy.

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I am a man between 18 and 55 years old.

ARCH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of AEs in those treated with EDG-5506

Incidence of AEs in those treated with EDG-5506

Severity of AEs in those treated with EDG-5506

Secondary outcome measures

Incidence of treatment-emergent abnormal clinical chemistry test results

Incidence of treatment-emergent abnormal coagulation test results

Incidence of treatment-emergent abnormal hematology test results

+13 more

Other outcome measures

Number of participants with changes in biomarkers of muscle fiber damage

ARCH Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Drug: EDG-5506

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EDG-5506

2022

Completed Phase 1

~150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medpace, Inc.Industry Sponsor

94 Previous Clinical Trials

29,603 Total Patients Enrolled

Edgewise Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

854 Total Patients Enrolled

Sam Collins, MBBS, PhDStudy ChairEdgewise Therapeutics, Inc.

6 Previous Clinical Trials

473 Total Patients Enrolled

Media Library

EDG-5506 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05160415 — Phase 1

Becker Muscular Dystrophy Research Study Groups: Treatment

Becker Muscular Dystrophy Clinical Trial 2023: EDG-5506 Highlights & Side Effects. Trial Name: NCT05160415 — Phase 1

EDG-5506 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160415 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with EDG-5506 intake?

"Due to the current lack of evidence, EDG-5506's safety was assigned a score of 1. This is because it is currently undergoing Phase I clinical trials which test for efficacy and initial safety data in humans."

Answered by AI

Are there any unfilled vacancies for participants in this research?

"The information on clinicaltrials.gov discloses that this trial is not presently recruiting participants, having originally been posted in December 2021 and last modified in October 2022. Nonetheless, there are 86 other studies actively searching for patients at the moment."

Answered by AI

Does this trial allow for participation by people under thirty years of age?

"This medical trial requires that potential participants are between 18 and 55. For those with ages outside of this range, there are currently 60 clinical trials for minors and 49 for the elderly available."

Answered by AI

May I be accepted as a participant in this investigation?

"This research seeks 12 individuals aged 18-55 who have muscular dystrophy. To qualify, participants must be male, maintain a body weight of 50 kg and Body Mass Index between 20-34kg/m2, and demonstrate the ability to complete a 100 meter timed test with or without assistance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy

2021. "A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05160415.