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Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

NCT03703882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2022-06-21

Study results available
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Summary

The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled.

Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

Conditions

  • Muscular Dystrophy, Duchenne

Interventions

DRUG

Edasalonexent

100 mg/kg/day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Catabasis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joanne M Donovan, Chief Medical Officer, MD, PhD · Catabasis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2020-09-22
Completion
2020-09-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Ireland
  • Israel
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703882 on ClinicalTrials.gov