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ALXN1850 in Adolescent and Adult Participants With Hypophosphatasia
NCT06079281Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2024
- Primary completion
- Jul 2025
- Countries
- 17
- Sponsor
- Alexion Pharmaceuticals
- Modality
- Replacement Enzymes, Fc-Fusion Proteins
- Drugs
- efzimfotase alfa
- Conditions
- hypophosphatasia (HPP)
01
Overview
Phase 3, randomised, double-blind trial in hypophosphatasia (HPP) comparing Placebo Group with ALXN1850 Group (2 arms). Primary endpoint: 6-Minute Walk Test at Day 169. Started Jan 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo Group
Placebo SC q2w for 24 weeks, followed by ALXN1850 SC q2w for up to 132 weeks.
ALXN1850 Group
ALXN1850 SC q2w for 24 weeks, followed by ALXN1850 SC q2w for up to 132 weeks.
03
Who it enrols
Adolescent and adult patients with documented hypophosphatasia, ALPL gene variant or elevated PLP/low ALP, and impaired 6MWT, who have not been previously treated with asfotase alfa.
04
Endpoints
Primary
6-Minute Walk Test
Secondary
30-second Sit to Stand Test
Lower Extremity Functional Scale
Brief Pain Inventory-Short Form
Functional Assessment of Chronic Illness Therapy-Fatigue
Timed Up-and-Go
Percent Predicted 6-Minute Walk Test
Radiographic Global Impression of Change
Radiographic Global Impression of Change Responder
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