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ACTIVE NOT RECRUITING
NCT06079359
PHASE3

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

Sponsor: Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-05-14

Completion Date

2028-08-24

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

DRUG

ALXN1850

Participants will receive a ALXN1850 via subcutaneous (SC) injection.

DRUG

Placebo

Participants will receive placebo via SC injection.

Locations (32)

Research Site

Baltimore, Maryland, United States

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Kansas City, Missouri, United States

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Durham, North Carolina, United States

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Nedlands, Australia

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Parkville, Australia

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Brussels, Belgium

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Brasília, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Winnepeg, Manitoba, Canada

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Beijing, China

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Guangzhou, China

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Shanghai, China

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Shenzhen, China

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Helsinki, Finland

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Ashkelon, Israel

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Chihuahua City, Mexico

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Lodz, Poland

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Bucharest, Romania

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Madrid, Spain

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Vitoria-Gasteiz, Spain

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Stockholm, Sweden

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Taipei, Taiwan

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Ankara, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Birmingham, United Kingdom