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

Daiichi Sankyo

Status and phase: Active, not recruiting; Phase 2

Conditions: Duchenne Muscular Dystrophy

Treatments: Drug: DS-5141b

Study type: Interventional

Funder types: Industry

Identifiers

NCT04433234

DS5141-A-J201

205321 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: Male

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

DS-5141b 2.0 mg/kg

Experimental group

Description:

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

Treatment:

Drug: DS-5141b

DS-5141b 6.0 mg/kg

Experimental group

Description:

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

Treatment:

Drug: DS-5141b