drugset
drugset / Trial / NCT06079359

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

NCT06079359 ↗

Phase 3 Active not recruiting 30 enrolled Alexion Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

Timeline

Start
2024-05-14
Primary completion
2026-01-06
Completion
2028-08-24

Outcome

Met primary endpoint

release “MULBERRY randomised, placebo-controlled trial showed efzimfotase alfa demonstrated statistically significant and clinically meaningful improvement in bone health in treatment-naïve paediatric patients” astrazeneca.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject efzimfotase alfa Protein / enzyme biologic 20 mg Subcutaneous
Subject efzimfotase alfa Protein / enzyme biologic 35 mg Subcutaneous
Subject efzimfotase alfa Protein / enzyme biologic 50 mg Subcutaneous

Indications

hypophosphatasia