Clinical Trials Logo
  1. Home
  2. Duchenne Muscular Dystrophy
  3. NCT05938023

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

Duchenne Muscular Dystrophy Clinical Trial

Official title:
A Multicentre, Randomised, Double-blind, Placebo-controlled and Open Label Extension Study to Assess the Efficacy, Safety, and Pharmacokinetic Profile of of ATL1102 in Non-ambulatory Participants With Duchenne Muscular Dystrophy

Clinical Trial 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).

Clinical Trial Description

This Phase IIb study is a two part, multicenter study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ATL1102 and will enroll 45 non-ambulant boys with Duchenne Muscular Dystrophy (DMD) aged 10 to <18 years old. During the 24 week randomised, double-blind, placebo-controlled treatment period (Part A) participants will be enrolled and randomised to receive either ATL1102 25mg, ATL1102 50mg or matched placebo in a 1:1:1 ratio given as a weekly subcutaneous injection. Participants will then continue to the 24 week Open Labelled Treatment Period (Part B) and continue to receive ATL1102 25mg or ATL1102 50mg for a further 24 weeks. Participants on placebo in Part A will transition to ATL1102. The study will consist of a 4 week screening period, 24 week randomised, double-blind, placebo-controlled treatment period (Part A), 24 week open label treatment period (Part B) and 16 week follow up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05938023
Study type Interventional
Source Percheron Therapeutics
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 18, 2023
Completion date March 5, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT05575648 - Dual Task in Duchenne Muscular Dystrophy N/A
Terminated NCT03907072 - Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy Phase 2/Phase 3
Not yet recruiting NCT06450639 - An Open-label Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy Phase 2
Completed NCT04335942 - Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor N/A
Active, not recruiting NCT04906460 - Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53) Phase 1/Phase 2
Active, not recruiting NCT02500381 - Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD) Phase 3
Enrolling by invitation NCT05967351 - A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study Phase 3
Recruiting NCT03067831 - Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy Phase 1/Phase 2
Recruiting NCT01834040 - Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy Phase 1/Phase 2
Completed NCT02246478 - A Study of TAS-205 for Duchenne Muscular Dystrophy Phase 1
Active, not recruiting NCT01772043 - Duchenne Muscular Dystrophy Tissue Bank for Exon Skipping N/A
Terminated NCT01168908 - Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy Phase 2
Completed NCT00758225 - Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Phase 2
Completed NCT03680365 - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Recruiting NCT03513367 - The Validation Process for Confirmation of the French Version of the Pediatric Quality of Life Inventory :PedsQLTM.
Recruiting NCT05712447 - Duchenne Muscular Dystrophy Video Assessment Registry
Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Completed NCT03319030 - Aerobic Exercise in Boys With Duchenne Muscular Dystrophy (DMD)
Terminated NCT01753804 - A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy. N/A
Completed NCT02530905 - Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients Phase 1