drugset / Trial / NCT06015750

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

NCT06015750

Phase 4 Withdrawn Alexion Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

Timeline

Start
2026-07-29
Primary completion
2030-03-13
Completion
2030-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic Intravenous
Subject Methotrexate Small molecule Subcutaneous
Subject Rituximab Monoclonal antibody Intravenous
Background folic acid Other / unclassified Oral

Indications