drugset
drugset / Trial / NCT04632940

Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD

NCT04632940 ↗

Phase 3 Terminated 73 enrolled Kyntra Bio
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids administered every 2 weeks in ambulatory participants with Duchenne muscular dystrophy (DMD) (age 6 to \<12 years).

Timeline

Start
2021-03-03
Primary completion
2023-06-12
Completion
2023-12-14

Outcome

Missed primary endpoint

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

registry analysis (other test); Pamrevlumab vs Placebo; p = 0.5553; LS Mean Difference -0.528 (95% CI -2.308 to 1.251); Mixed Models Analysis NCT04632940 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamrevlumab Monoclonal antibody 35 mg/kg Intravenous
Background Deflazacort Other / unclassified — Oral

Indications

Duchenne muscular dystrophy