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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
ALXN1850 will be administered via subcutaneous (SC) injection.
Asfotase alfa will be administered via SC injection.
Research Site
Hartford, Connecticut, United States
Research Site
Baltimore, Maryland, United States
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline Through Day 169
Radiographic Global Impression of Change (RGI-C) Score at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
Change from Baseline in Rickets Severity Score (RSS) at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
Change from Baseline in 6-Minute Walk Test (6MWT) at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
Change from Baseline in Percent Predicted 6MWT at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
Change from Baseline in Bruininks Oseretsky Test of Motor Proficiency, Second Edition (BOT2) Score at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
Change from Baseline in Peabody Developmental Motor Scales, Third Edition (PDMS-3) Score at the end of the Randomized Evaluation Period (Day 169)
Time frame: Baseline, Day 169
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 11 more locations