Who is eligible for clinical trial NCT06079281?

Participants must meet protocol criteria for Hypophosphatasia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06079281 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-17

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa (NCT06079281)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Alexion Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Research Site — Indianapolis, Indiana

Age range: 12 Years to 130 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (65 Sites)

Showing the first 25 of 65 sites.

Research Site — Indianapolis, Indiana
Research Site — Garden City, New York
Research Site — Durham, North Carolina
Research Site — Columbus, Ohio
Research Site — Nashville, Tennessee
Research Site — Ciudad de Buenos Aires,
Research Site — Clayton,
Research Site — Herston,
Research Site — Parkville,
Research Site — St Leonards,
Research Site — Belo Horizonte,
Research Site — Brasília,
Research Site — Recife,
Research Site — Salvador,
Research Site — São Paulo,
Research Site — São Paulo,
Research Site — Calgary, Alberta
Research Site — Edmonton, Alberta
Research Site — Winnepeg, Manitoba
Research Site — Oakville, Ontario
Research Site — Trois-Rivières, Quebec
Research Site — Beijing,
Research Site — Beijing,
Research Site — Changsha,
Research Site — Chengdu,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Hypophosphatasia

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP — Baltimore, Maryland
Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa — Hartford, Connecticut
Natural History Study of Patients With Hypophosphatasia (HPP) — Durham, North Carolina
A Prospective Sub-Study of the Global Hypophosphatasia Registry — Hartford, Connecticut

Explore by condition: All Hypophosphatasia clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗