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ACTIVE NOT RECRUITING
NCT06079372
PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-04-02

Completion Date

2028-02-29

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

ALXN1850

ALXN1850 will be administered via subcutaneous (SC) injection.

DRUG

asfotase alfa

Asfotase alfa will be administered via SC injection.

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

Research Site

Minatoku, Japan

Research Site

Suita-shi, Japan

Research Site

Yonago-shi, Japan

Research Site

Altındağ, Turkey (Türkiye)

Research Site

Ankara, Turkey (Türkiye)

Research Site

Edirne, Turkey (Türkiye)

Research Site

Erzurum, Turkey (Türkiye)

Research Site

Istanbul, Turkey (Türkiye)

Research Site

Birmingham, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Sheffield, United Kingdom