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

Study Identifier:
D8400C00001
ClinicalTrials.gov Identifier:
NCT06015750
EudraCT Identifier:
2022-502793-17
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: methotrexate
  • Drug: rituximab
  • Drug: bortezomib
  • Drug: IVIg
  • Drug: Folic Acid
Date
Jul 2025 - Feb 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years
Requirements Information
Sex
Female & Male
Age
2 - 18 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: methotrexate
  • Drug: rituximab
  • Drug: bortezomib
  • Drug: IVIg
  • Drug: Folic Acid
Date
Jul 2025 - Feb 2029
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 2 - 18 Years years
Requirements Information

Protocol 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).

Trial Locations

Location
Status
Location
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Status
N/A
Location
Research Site
Nashville, Tennessee, United States, 37212
Status
N/A
Location
Research Site
Le Kremlin-Bicêtre, France, 94270
Status
N/A
Location
Research Site
Manchester, United Kingdom, M13 9WL
Status
N/A