Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa
NCT ID: NCT06079372
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
43 participants
INTERVENTIONAL
2024-04-02
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALXN1850
Starting at Day 1 of the Randomized Evaluation Period participants will receive ALXN1850 for a total of 24 weeks. Participants will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection. During Part A of the OLE Period, participants will have frequent visits over the first 24 weeks; Part B of the OLE Period participants will have visits every 9 months for up to approximately 108 weeks.
ALXN1850
ALXN1850 will be administered via subcutaneous (SC) injection.
asfotase alfa
Asfotase alfa will be administered via SC injection.
asfotase alfa
Starting at Day 1 of the Randomized Evaluation Period, participants will receive asfotase alfa for a total of 24 weeks. Participants will receive 6 mg/kg/week of asfotase alfa via SC injection as either 2 mg/kg 3 times per week or 1 mg/kg 6 times per week. Part A of the OLE Period participants will have frequent visits over the first 24 weeks; Part B will have visits every 9 months for up to approximately 108 weeks.
asfotase alfa
Asfotase alfa will be administered via SC injection.
Interventions
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ALXN1850
ALXN1850 will be administered via subcutaneous (SC) injection.
asfotase alfa
Asfotase alfa will be administered via SC injection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
11 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ALXN1850-HPP-303
Identifier Type: OTHER
Identifier Source: secondary_id
D8590C00004
Identifier Type: -
Identifier Source: org_study_id