drugset / Trial / NCT06015750
Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia
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
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision following FDA release from the PMR.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |