Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-03 @ 12:08 PM
Study NCT ID:
NCT06079359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2023-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP
Sponsor:
Alexion Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 Versus Placebo Administered Subcutaneously in Pediatric (2 to < 12 Years of Age) Participants With Hypophosphatasia Who Have Not Received Previous Treatment With Asfotase Alfa
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MULBERRY
Brief Summary:
The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ALXN1850-HPP-305 | OTHER | Alexion Pharmaceuticals, Inc. | View |