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

Running, not enrolling · Phase 3

Conditions studied: Hypophosphatasia

In brief

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.

Key facts

Study ID: NCT06079372
Run by: Alexion Pharmaceuticals, Inc.
People needed: 43
Starts: 2024-04-02
Expected to finish: 2028-02-29
Last updated by the study team: 2026-05-05

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of HPP documented in the medical records
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.

You may not qualify if…

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator.
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

Where it is running

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

Full record on ClinicalTrials.gov

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