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A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy

NCT05938023 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-03

No results posted yet for this study

Summary

This Phase IIb study is a two part, multicenter study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ATL1102 in non-ambulant boys with Duchenne Muscular Dystrophy aged 10 to \<18 years old. The study includes a randomised, double-blind, placebo-controlled treatment period (Part A), followed by an open labelled treatment period (Part B).

Conditions

Interventions

DRUG

ATL1102 25mg

Dose and scheduled as specified in the Arm description

DRUG

ATL1102 50mg

Dose and scheduled as specified in the Arm description

DRUG

Placebo

Dose and scheduled as specified in the Arm description

Sponsors & Collaborators

  • Percheron Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thomas Voit · UCL Great Ormond Street Institute of Child Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2024-11-19
Completion
2025-01-15

Countries

  • Australia
  • Bulgaria
  • Serbia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05938023 on ClinicalTrials.gov