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ACTIVE_NOT_RECRUITINGPHASE3

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

NCT06079372•Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of HPP documented in the medical records
•Presence of open growth plates by X-ray during Screening Period
•Tanner stage 2 or less during the Screening Period
•Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study.

Exclusion Criteria

•History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator.
•Diagnosis of primary or secondary hyperparathyroidism
•Hypoparathyroidism, unless secondary to HPP
•Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
•Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
•History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850
•Body weight \< 10 kg during the Screening Period

Locations (21)

Research Site

Hartford, Connecticut, United States

Research Site

Baltimore, Maryland, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

Kansas City, Missouri, United States

Research Site

Durham, North Carolina, United States

Research Site

Nashville, Tennessee, United States

Research Site

Mar del Plata, Argentina

Research Site

South Brisbane, Australia

Research Site

Ottawa, Ontario, Canada

Research Site

Bunkyō City, Japan

Key Dates

Start Date

April 2, 2024

Primary Completion Date

July 23, 2025

Completion Date

February 29, 2028

Last Updated

March 12, 2026

Enrollment

ACTUAL participants

Conditions

Hypophosphatasia

Interventions

ALXN1850

DRUG

asfotase alfa

DRUG

The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia

NCT07390240

Hypophosphatasia

View study

RECRUITING

A Prospective Sub-Study of the Global Hypophosphatasia Registry

NCT05234567

Hypophosphatasia

View study

RECRUITINGPHASE1/PHASE2

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia

A Prospective Sub-Study of the Global Hypophosphatasia Registry

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia

Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)

Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)