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: 05 Nov 2025
Estimated Study Completion Date: 02 Nov 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Group During the Randomized Evaluation Period, the placebo group will receive placebo on Day 1, followed by once every 2 weeks (q2w) via SC injection for 24 weeks. Participants will enter the OLE Period and receive bodyweight dependent doses of either 20mg, 35mg, or 50mg of ALXN1850 and continue q2w dosing with ALXN1850 for up to 132 weeks. | Drug: Placebo Placebo will be administered via SC injection. |
| Experimental: ALXN1850 Group Starting at Day 1 of the Randomized Evaluation Period, the ALXN1850 group will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection, for 24 weeks. Participants will enter the OLE Period and continue q2w dosing with ALXN1850 for up to 132 weeks. | Drug: ALXN1850 ALXN1850 will be administered via subcutaneous (SC) injection. Drug: Placebo Placebo will be administered via SC injection. |
