Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)

Summary

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in participants with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

Timeline

Start

2020-08-10

Primary completion

2023-02-13

Completion

2023-08-17

Outcome

Missed primary endpoint

Stopped: “Study did not meet its primary endpoint.”

registry analysis (other test); Pamrevlumab vs Placebo; p = 0.8802; Least square (LS) Mean Difference 0.083 (95% CI -1.010 to 1.176) NCT04371666 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pamrevlumab	Monoclonal antibody	35 mg/kg	Intravenous
Background	Deflazacort	Other / unclassified	—	Oral

Indications