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New hope for rare bone disease: experimental drug aims to help patients walk better

NCT ID NCT06079281

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests an experimental drug called ALXN1850 in 124 adolescents and adults with hypophosphatasia, a rare genetic bone disease. Participants receive either the drug or a placebo by injection under the skin. The main goal is to see if the drug improves walking distance in 6 minutes, with other measures like sit-to-stand ability and pain. The study is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALXN1850 (recombinant alkaline phosphatase)
What this could lead to
If successful, this could provide a new treatment option for hypophosphatasia, improving mobility and reducing pain for people who have not used other therapies.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not work better than placebo, and side effects from the injection or the drug itself are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

124 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

hypophosphatasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypophosphatasia

Contacts and locations

Locations

  • Research Site

    Indianapolis, Indiana, 46202, United States

  • Research Site

    Garden City, New York, 11530, United States

  • Research Site

    Durham, North Carolina, 27705, United States

  • Research Site

    Columbus, Ohio, 43203, United States

  • Research Site

    Nashville, Tennessee, 37212, United States

  • Research Site

    Ciudad de Buenos Aires, C1199, Argentina

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Herston, 4029, Australia

  • Research Site

    Parkville, 3052, Australia

  • Research Site

    St Leonards, 2065, Australia

  • Research Site

    Belo Horizonte, 30130-100, Brazil

  • Research Site

    Brasília, 71625-009, Brazil

  • Research Site

    Recife, 50740-465, Brazil

  • Research Site

    Salvador, 40050-410, Brazil

  • Research Site

    São Paulo, 01409-902, Brazil

  • Research Site

    São Paulo, 05403-900, Brazil

  • Research Site

    Calgary, Alberta, T2E 7H7, Canada

  • Research Site

    Edmonton, Alberta, T6G 2R7, Canada

  • Research Site

    Winnepeg, Manitoba, R3E 3P4, Canada

  • Research Site

    Oakville, Ontario, L6M 1M1, Canada

  • Research Site

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Research Site

    Beijing, 100039, China

  • Research Site

    Beijing, 100730, China

  • Research Site

    Changsha, 430033, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Qingdao, 266035, China

  • Research Site

    Shanghai, 201306, China

  • Research Site

    Shenzhen, 518053, China

  • Research Site

    Paris, 75014, France

  • Research Site

    Poitiers, 86000, France

  • Research Site

    Bad Reichenhall, 83435, Germany

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Bonn, 53127, Germany

  • Research Site

    Hamburg, 20251, Germany

  • Research Site

    Würzburg, 97074, Germany

  • Research Site

    Ashkelon, 7830604, Israel

  • Research Site

    Ramat Gan, 52621, Israel

  • Research Site

    Florence, 50139, Italy

  • Research Site

    Milan, 20122, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Pisa, 56126, Italy

  • Research Site

    San Giovanni Rotondo, 71013, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Iizuka-shi, 820-8505, Japan

  • Research Site

    Osaka, 545-8586, Japan

  • Research Site

    Sapporo, 060-8648, Japan

  • Research Site

    Yaizu-shi, 425-8505, Japan

  • Research Site

    Lodz, 93-338, Poland

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 07061, South Korea

  • Research Site

    Suwon, 16499, South Korea

  • Research Site

    Barcelona, 08003, Spain

  • Research Site

    Granada, 18016, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    San Cristóbal de La Laguna, 38320, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Vitoria-Gasteiz, 01009, Spain

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Ankara, 06560, Turkey (Türkiye)

  • Research Site

    Yakutiye, 25040, Turkey (Türkiye)

  • Research Site

    London, SW170QT, United Kingdom

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