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

NCT06015750 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-12-18

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-29
Primary Completion
2030-03-13
Completion
2030-03-13
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015750 on ClinicalTrials.gov