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Clinical Trials in the UK / NCT06079372
Active, not recruiting Phase 3

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

NCT06079372 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-04-02
Last updated
2026-05-05

Condition(s) studied

Hypophosphatasia

Investigational drug(s) / intervention(s)

ALXN1850asfotase alfa

ALXN1850: ALXN1850 will be administered via subcutaneous (SC) injection.

asfotase alfa: Asfotase alfa will be administered via SC injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Research Site Hartford Connecticut
Research Site Baltimore Maryland
Research Site Minneapolis Minnesota
Research Site Kansas City Missouri
Research Site Durham North Carolina
Research Site Nashville Tennessee
Research Site Mar del Plata Argentina
Research Site South Brisbane Australia
Research Site Ottawa Ontario
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

More Alexion Pharmaceuticals, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079372 on ClinicalTrials.gov ↗ ← All trials in the UK