drugset
drugset / Trial / NCT06079281

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

NCT06079281 ↗

Phase 3 Active not recruiting 124 enrolled Alexion Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

Timeline

Start
2024-01-03
Primary completion
2025-07-09
Completion
2028-03-29

Outcome

Missed primary endpoint

release “In the HICKORY Phase III trial, efzimfotase alfa showed numerical improvement but did not achieve statistical significance in the primary endpoint” 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