CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
DS-5141bdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02667483
NCT02667483Phase 2Completed
CompareCT.gov

Phase I/II Study of DS-5141b: Open-label Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

Daiichi Sankyo Co., Ltd.·interventional·Posted Jan 29, 2016·Updated Mar 7, 2024

In Brief

A Phase 2 clinical trial evaluating DS-5141b for Duchenne Muscular Dystrophy. Completed, enrolled 8 participants across 2 sites.

Detailed Summary

This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping and to determine the dosage for subsequent studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesJapan
CollaboratorsDaiichi Sankyo

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 29, 2016
Enrollment StartOct 1, 2015
Primary CompletionOct 20, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.4 years ago

Interventions

DS-5141bdrug

DS-5141b, Subcutaneous injection