Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

NCT ID: NCT04433234

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2027-01-31

Brief Summary

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This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.

Detailed Description

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Conditions

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Duchenne Muscular Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DS-5141b 2.0 mg/kg

Participants who will receive DS-5141b 2.0 mg/kg once weekly.

Group Type EXPERIMENTAL

DS-5141b

Intervention Type DRUG

Administered via subcutaneous injection once weekly

DS-5141b 6.0 mg/kg

Participants who will receive DS-5141b 6.0 mg/kg once weekly.

Group Type EXPERIMENTAL

DS-5141b

Intervention Type DRUG

Administered via subcutaneous injection once weekly

Interventions

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DS-5141b

Administered via subcutaneous injection once weekly

Intervention Type DRUG

Other Intervention Names

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Renadirsen

Eligibility Criteria

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Inclusion Criteria

* Has competed a study of DS5141-A-J101

Exclusion Criteria

* Significant safety issues in a study of DS5141-A-J101
* Patient who does not consent to use appropriate contraception
* Patient not appropriate to participant in the study as determined by the Investigator
Minimum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Study Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo Co., Ltd.

Locations

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National Center of Neurology and Psychiatry

Tokyo, Kodaira-Shi, Japan

Site Status

Kobe University Hospital

Hyōgo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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205321

Identifier Type: OTHER

Identifier Source: secondary_id

DS5141-A-J201

Identifier Type: -

Identifier Source: org_study_id

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