Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

July 29, 2026

Primary Completion Date

March 13, 2030

Study Completion Date

March 13, 2030

Conditions
Hypophosphatasia
Interventions
DRUG

methotrexate

Methotrexate will be administered SC or orally weekly for 104 weeks.

DRUG

rituximab

Rituximab will be administered intravenously (IV) continuously weekly, for up to 74 weeks.

DRUG

bortezomib

Bortezomib will be administered via IV bolus or SC, as needed.

DRUG

IVIg

IVIg will be administered via IV monthly through initial 74 weeks.

DRUG

Folic Acid

Folic acid will be given orally as long as methotrexate is being dosed.

Trial Locations (2)

15213

Research Site, Pittsburgh

94270

Research Site, Le Kremlin-Bicêtre

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY