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Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP
Sponsor: Alexion Pharmaceuticals, Inc.
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
Conditions
Interventions
ALXN1850
Participants will receive a ALXN1850 via subcutaneous (SC) injection.
Placebo
Participants will receive placebo via SC injection.
Locations (32)
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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