A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy（REACH-DMD）

• Status: Recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Criteria

Key Inclusion Criteria:

• Patients with a diagnosis of dystrophinopathy as determined by a dystrophin genetic test at the time of informed consent, symptoms or signs characteristic to DMD (e.g., proximal muscular weakness, waddling gait, Gower's sign)

• Patients aged 5 years or more at the time of informed consent

• Patients who meet all of the following at the time of screening test

• walk by themselves

• time to rise from the floor on own is ≥ 3 seconds and <10 seconds

• Patients who can expect a 6-minute walking test of 350 meters or more

• If taking oral glucocorticoids no significant change in the total daily or dosing 6 months before enrollment.

Key Exclusion Criteria

• Patients who have serious concomitant drug hypersensitivity or medical history

• Patients who have used cyclooxygenase-1 (COX-1) or COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs) during 7 days before the measurement of time to rise from the floor in the screening period

• Patients who have incurred an injury (trauma/damage) that may affect muscle strength or motor function within 3 months before enrollment or who have an uncured injury (trauma/damage) that may affect muscle strength or motor function at the enrollment

• Patients who have received gene-/cell-based therapy or stop-codon readthrough therapy with antisense oligonucleotides

• Patients who have participated in another clinical trial and received a study drug within 90 days before study drug administration in the present study

• Patients with a left ventricular ejection fraction (EF) of <40% or left ventricular fractional shortening (FS) of <25% on the cardiac ultrasonography (echocardiography) at observation period