Phase 3 Study of ALXN1850 in Pediatric Participants with HPP Previously Treated with Asfotase Alfa - CHESTNUT

Study identifier:D8590C00004

ClinicalTrials.gov identifier:NCT06079372

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase 3, Randomized, Open-label, Parallel-arm, Active-controlled, Multicenter Study to Evaluate Safety and Efficacy of ALXN1850 Versus Asfotase Alfa Administered Subcutaneously in Pediatric Participants (2 to < 12 years of age) with Hypophosphatasia (HPP) Previously Treated with Asfotase Alfa

Medical condition

Hypophosphatasia

Phase

Phase 3

Healthy volunteers

Study drug

ALXN1850, asfotase alfa

Sex

All

Estimated Enrollment

Study type

Interventional

Age

2 Years - 11 Years

Date

Study Start Date: 02 Apr 2024

Estimated Primary Completion Date: 16 Jun 2025

Estimated Study Completion Date: 24 Jan 2028

Study design

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

Verification:

Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.

Collaborators

Inclusion and exclusion criteria

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No locations available

Arms	Assigned Interventions
Experimental: ALXN1850 Starting at Day 1 of the Randomized Evaluation Period participants will receive ALXN1850 for a total of 24 weeks. Participants will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection. During Part A of the OLE Period, participants will have frequent visits over the first 24 weeks; Part B of the OLE Period participants will have visits every 9 months for up to approximately 108 weeks.	Drug: ALXN1850 ALXN1850 will be administered via subcutaneous (SC) injection. Drug: asfotase alfa Asfotase alfa will be administered via SC injection.
Experimental: asfotase alfa Starting at Day 1 of the Randomized Evaluation Period, participants will receive asfotase alfa for a total of 24 weeks. Participants will receive 6 mg/kg/week of asfotase alfa via SC injection as either 2 mg/kg 3 times per week or 1 mg/kg 6 times per week. Part A of the OLE Period participants will have frequent visits over the first 24 weeks; Part B will have visits every 9 months for up to approximately 108 weeks.	Drug: asfotase alfa Asfotase alfa will be administered via SC injection.

Arms

Assigned Interventions

Experimental: ALXN1850
Starting at Day 1 of the Randomized Evaluation Period participants will receive ALXN1850 for a total of 24 weeks. Participants will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection. During Part A of the OLE Period, participants will have frequent visits over the first 24 weeks; Part B of the OLE Period participants will have visits every 9 months for up to approximately 108 weeks.

Drug: ALXN1850
ALXN1850 will be administered via subcutaneous (SC) injection.

Drug: asfotase alfa
Asfotase alfa will be administered via SC injection.

Experimental: asfotase alfa
Starting at Day 1 of the Randomized Evaluation Period, participants will receive asfotase alfa for a total of 24 weeks. Participants will receive 6 mg/kg/week of asfotase alfa via SC injection as either 2 mg/kg 3 times per week or 1 mg/kg 6 times per week. Part A of the OLE Period participants will have frequent visits over the first 24 weeks; Part B will have visits every 9 months for up to approximately 108 weeks.

Drug: asfotase alfa
Asfotase alfa will be administered via SC injection.

Contacts

Contact

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356

[email protected]