Trials / Active Not Recruiting

Active Not RecruitingNCT06079372

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

A Phase 3, Randomized, Open-label, Parallel-arm, Active-controlled, Multicenter Study to Evaluate Safety and Efficacy of ALXN1850 Versus Asfotase Alfa Administered Subcutaneously in Pediatric Participants (2 to < 12 Years of Age) With Hypophosphatasia (HPP) Previously Treated With Asfotase Alfa

Status: Active Not Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 43 (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 assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.

Conditions

Hypophosphatasia

Interventions

Type	Name	Description
DRUG	ALXN1850	ALXN1850 will be administered via subcutaneous (SC) injection.
DRUG	asfotase alfa	Asfotase alfa will be administered via SC injection.

Timeline

Start date: 2024-04-02
Primary completion: 2025-07-23
Completion: 2028-02-29
First posted: 2023-10-12
Last updated: 2026-03-12

Locations

21 sites across 7 countries: United States, Argentina, Australia, Canada, Japan, Turkey (Türkiye), United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06079372. Inclusion in this directory is not an endorsement.