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ACTIVE NOT RECRUITING

NCT06079281

PHASE3

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

Sponsor: Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

Official title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 (Recombinant Alkaline Phosphatase) Administered Subcutaneously in Adolescent (12 to < 18 Years of Age) and Adult Participants With Hypophosphatasia Who Have Not Previously Been Treated With Asfotase Alfa

Key Details

Gender

All

Age Range

12 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-01-03

Completion Date

2028-03-29

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Hypophosphatasia

Interventions

DRUG

ALXN1850

ALXN1850 will be administered via subcutaneous (SC) injection.

DRUG

Placebo

Placebo will be administered via SC injection.

Inclusion Criteria: * Diagnosis of HPP documented in the medical records * Must meet 1 of the following criteria: 1. Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified laboratory (Section 8.7 ) 2. Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations) * Must meet 1 of the following criteria without a probably cause other than HPP: 1. Serum ALP activity below the age- and sex-adjusted normal range during the screening period as measured by the Central Laboratory 2. Two documented serum ALP activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the Day 1 Visit. Note: Local laboratories need to be CLIA or ISO 15189 certified, or have other local equivalent laboratory certification with Alexion's approval. * Two separate 6MWTs at below 85% of the predicted distance (for age, sex, weight, and height) during the Screening Period without a probable cause other than HPP Exclusion Criteria: * 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 ALXN1850 or the placebo comparator (Table 9)

Locations (65)

Research Site

Indianapolis, Indiana, United States

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Garden City, New York, United States

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Durham, North Carolina, United States

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Columbus, Ohio, United States

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Nashville, Tennessee, United States

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Ciudad de Buenos Aires, Argentina

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Clayton, Australia

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Herston, Australia

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Parkville, Australia

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St Leonards, Australia

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Belo Horizonte, Brazil

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Brasília, Brazil

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Recife, Brazil

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Winnepeg, Manitoba, Canada

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Oakville, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Beijing, China

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Beijing, China

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Changsha, China

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Chengdu, China

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Nanchang, China

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Qingdao, China

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Shanghai, China

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Shenzhen, China

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Paris, France

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Poitiers, France

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Bad Reichenhall, Germany

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Berlin, Germany

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Bonn, Germany

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Hamburg, Germany

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Würzburg, Germany

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Ashkelon, Israel

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Ramat Gan, Israel

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Padova, Italy

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Pisa, Italy

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San Giovanni Rotondo, Italy

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Verona, Italy

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Hiroshima, Japan

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Iizuka-shi, Japan

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Osaka, Japan

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Sapporo, Japan

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Yaizu-shi, Japan

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Lodz, Poland

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Barcelona, Spain

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Granada, Spain

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Madrid, Spain

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San Cristóbal de La Laguna, Spain

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Santander, Spain

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Vitoria-Gasteiz, Spain

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Ankara, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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London, United Kingdom

Clinical Research Directory

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)