Phase 3 Study of ALXN1850 versus Placebo in Adolescent and Adult Participants with HPP who have not previously been treated with Asfotase Alfa - HICKORY

Study identifier:D8590C00002

ClinicalTrials.gov identifier:NCT06079281

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Hypophosphatasia

Phase

Phase 3

Healthy volunteers

No

Study drug

ALXN1850, Placebo

Sex

All

Estimated Enrollment

114

Study type

Interventional

Age

12 Years - 130 Years

Date

Study Start Date: 03 Jan 2024
Estimated Primary Completion Date: 23 Dec 2025
Estimated Study Completion Date: 24 Jul 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.

Sponsors

Alexion Pharmaceuticals, Inc.

Collaborators

-

Inclusion and exclusion criteria