NCT06079359

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

A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 Versus Placebo Administered Subcutaneously in Pediatric (2 to < 12 Years of Age) Participants With Hypophosphatasia Who Have Not Received Previous Treatment With Asfotase Alfa

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypophosphatasia

Interventions

Type	Name	Description
DRUG	ALXN1850	Participants will receive a ALXN1850 via subcutaneous (SC) injection.
DRUG	Placebo	Participants will receive placebo via SC injection.

Timeline

• Start date: 2024-05-14
• Primary completion: 2026-01-06
• Completion: 2028-08-24
• First posted: 2023-10-12
• Last updated: 2026-02-18

Locations

32 sites across 16 countries: United States, Australia, Belgium, Brazil, Canada, China, Finland, Israel, Mexico, Poland, Romania, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study