Status:
ACTIVE_NOT_RECRUITING
Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hypophosphatasia
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2028
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06079372
Start Date
April 2 2024
End Date
February 29 2028
Last Update
November 13 2025
Active Locations (21)
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1
Research Site
Hartford, Connecticut, United States, 06106
2
Research Site
Baltimore, Maryland, United States, 21287
3
Research Site
Minneapolis, Minnesota, United States, 55455
4
Research Site
Kansas City, Missouri, United States, 64108