Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP
NCT ID: NCT06079359
Last Updated: 2026-01-14
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
30 participants
INTERVENTIONAL
2024-05-14
2028-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALXN1850
Starting at Day 1 of the Randomized Evaluation Period, the ALXN1850 group will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once every 2 weeks (q2w) via SC injection, for 24 weeks. Participants will enter the OLE Period and continue q2w dosing with ALXN1850 for up to 132 weeks.
ALXN1850
Participants will receive a ALXN1850 via subcutaneous (SC) injection.
Placebo
Participants will receive placebo via SC injection.
Placebo
Starting at Day 1 during the Randomized Evaluation Period, participants will receive placebo q2w for a total of 24 weeks. Participants will enter the OLE Period and continue q2w dosing with ALXN1850 for up to 132 weeks.
Placebo
Participants will receive placebo via SC injection.
Interventions
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ALXN1850
Participants will receive a ALXN1850 via subcutaneous (SC) injection.
Placebo
Participants will receive placebo via SC injection.
Eligibility Criteria
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Inclusion Criteria
1. Presence of HPP-related rickets on skeletal X-rays during the Screening Period, with a minimum Rickets Severity Score (RSS) of 1.0 AND
2. Serum ALP activity below the age- and sex-adjusted normal range during the Screening Period as measured by the Central Laboratory OR 2 documented serum ALP activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the Day 1 Visit. Note: Local laboratories need to be Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified, or have other local equivalent laboratory certification with Alexion's approval.
* Must meet 1 of the following criteria:
1. Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a CLIA certified laboratory (Section 8.7)
2. Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations)
* Tanner stage 2 or less during the Screening Period
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 ALXN1850 or the placebo comparator
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
Baltimore, Maryland, United States
Research Site
Kansas City, Missouri, United States
Research Site
Durham, North Carolina, United States
Research Site
Nedlands, , Australia
Research Site
Parkville, , Australia
Research Site
Brussels, , Belgium
Research Site
Brasília, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Recife, , Brazil
Research Site
Salvador, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Winnepeg, Manitoba, Canada
Research Site
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Shanghai, , China
Research Site
Shenzhen, , China
Research Site
Helsinki, , Finland
Research Site
Ashkelon, , Israel
Research Site
Chihuahua City, , Mexico
Research Site
Lodz, , Poland
Research Site
Bucharest, , Romania
Research Site
Madrid, , Spain
Research Site
Vitoria-Gasteiz, , Spain
Research Site
Stockholm, , Sweden
Research Site
Taipei, , Taiwan
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Bursa, , Turkey (Türkiye)
Research Site
Erzurum, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Birmingham, , United Kingdom
Countries
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Other Identifiers
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ALXN1850-HPP-305
Identifier Type: OTHER
Identifier Source: secondary_id
D8590C00003
Identifier Type: -
Identifier Source: org_study_id
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