NCT06079281

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 (Recombinant Alkaline Phosphatase) Administered Subcutaneously in Adolescent (12 to < 18 Years of Age) and Adult Participants With Hypophosphatasia Who Have Not Previously Been Treated With Asfotase Alfa

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

Conditions

• Hypophosphatasia

Interventions

Type	Name	Description
DRUG	ALXN1850	ALXN1850 will be administered via subcutaneous (SC) injection.
DRUG	Placebo	Placebo will be administered via SC injection.

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-07-09
• Completion: 2028-03-29
• First posted: 2023-10-12
• Last updated: 2026-03-12

Locations

65 sites across 17 countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study