A Phase 3, Randomized, Open-label, Parallel-arm, Active-controlled, Multicenter Study to Evaluate Safety and Efficacy of ALXN1850 Versus Asfotase Alfa Administered Subcutaneously in Pediatric Participants (2 to < 12 Years of Age) With Hypophosphatasia (HPP) Previously Treated With Asfotase Alfa

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06079372Tipo: INTERVENTIONALInicio: 2 de abr de 2024Fin estimado: 29 de feb de 2028

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.

Elegibilidad

Edad mínima: 2 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

Diagnosis of HPP documented in the medical records
Presence of open growth plates by X-ray during Screening Period
Tanner stage 2 or less during the Screening Period
Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study.

Criterios de exclusión

History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator.
Diagnosis of primary or secondary hyperparathyroidism
Hypoparathyroidism, unless secondary to HPP
Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850
Body weight \< 10 kg during the Screening Period

Intervenciones

drug

ALXN1850

ALXN1850 will be administered via subcutaneous (SC) injection.

drug

asfotase alfa

Asfotase alfa will be administered via SC injection.

Ubicaciones

Research Site

Mar del Plata, Argentina

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

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