Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Last updated: March 17, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

asfotase alfa

ALXN1850

Clinical Study ID

NCT06079372
D8590C00004
ALXN1850-HPP-303
  • Ages 2-11
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 injectionadministered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6months 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.

Exclusion

Exclusion Criteria:

  • History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrinological, hematological, neurological disorders, or anyother disorders that are capable of significantly altering the absorption,metabolism, or elimination of drugs; constituting a risk when taking the studyintervention; or interfering with the interpretation of data as determined by theInvestigator.

  • 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 (inthe opinion of the Investigator) during the Randomized Evaluation Period

  • History of allergy or hypersensitivity to any ingredient contained in asfotase alfaor ALXN1850

  • Body weight < 10 kg during the Screening Period

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: asfotase alfa
Phase: 3
Study Start date:
April 02, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Research Site

    Buenos Aires, C1425BPE
    Argentina

    Site Not Available

  • Research Site

    Córdoba, 5000
    Argentina

    Site Not Available

  • Research Site

    Mar del Plata, B7600
    Argentina

    Site Not Available

  • Research Site

    South Brisbane, 4101
    Australia

    Site Not Available

  • Research Site

    Westmead, 2145
    Australia

    Site Not Available

  • Research Site

    Winnepeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Research Site

    Le Kremlin Bicêtre, 94270
    France

    Site Not Available

  • Research Site

    Paris, 75015
    France

    Site Not Available

  • Research Site

    Homburg, 66421
    Germany

    Site Not Available

  • Research Site

    Würzburg, 97074
    Germany

    Site Not Available

  • Research Site

    Bangalore, 560017
    India

    Site Not Available

  • Research Site

    Genova, 16147
    Italy

    Site Not Available

  • Research Site

    Milano, 20133
    Italy

    Site Not Available

  • Research Site

    Roma, 00190
    Italy

    Site Not Available

  • Research Site

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • Research Site

    Kyoto-shi, 606-8507
    Japan

    Site Not Available

  • Research Site

    Minato-ku, 105-8471
    Japan

    Site Not Available

  • Research Site

    Suita-shi, 565-0871
    Japan

    Site Not Available

  • Research Site

    Yonago-shi, 683-8504
    Japan

    Site Not Available

  • Research Site

    Altındağ, 06230
    Turkey

    Site Not Available

  • Research Site

    Altındağ-Ankara, 06230
    Turkey

    Site Not Available

  • Research Site

    Ankara, 06560
    Turkey

    Site Not Available

  • Research Site

    Bursa, 16059
    Turkey

    Site Not Available

  • Research Site

    Edirne, 22030
    Turkey

    Site Not Available

  • Research Site

    Erzurum, 25240
    Turkey

    Site Not Available

  • Research Site

    Istambul, 34899
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34020
    Turkey

    Site Not Available

  • Research Site

    Küçükçekmece, 34295
    Turkey

    Site Not Available

  • Research Site

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Research Site

    Manchester,
    United Kingdom

    Site Not Available

  • Research Site

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • Research Site

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Research Site

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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