15 Participants Needed

Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

Recruiting at 5 trial locations
AP
Overseen ByAlexion Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ALXN1850 to see if it is safe and effective for adults with Hypophosphatasia (HPP). The drug will be given either through a vein or under the skin. Researchers want to understand how the drug moves through the body, its effects, and if it causes any immune reactions. Asfotase alfa (Strensiq™) is a first-in-class bone-targeted human recombinant tissue-nonspecific alkaline phosphatase (TNSALP) replacement therapy approved for treating hypophosphatasia (HPP).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using asfotase alfa, you must have stopped it at least 6 months before joining the trial.

Eligibility Criteria

Inclusion Criteria

Confirmed clinical diagnosis of HPP
Not anticipated to require further treatment with enzyme replacement therapy to treat participant's HPP after study completion
Willing and able to follow protocol-specified contraception requirements
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALXN1850 via IV infusion and/or SC in a dose-escalating manner

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ALXN1850
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ALXN1850Experimental Treatment1 Intervention
Three experimental cohorts will be administered 3 dosages (low, medium, high) of ALXN1850, respectively, via IV infusion and/or SC over multiple administration intervals.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexion

Lead Sponsor

Trials
247
Recruited
38,600+
Marc Dunoyer profile image

Marc Dunoyer

Alexion

Chief Executive Officer since 2021

PhD in Molecular Biology, University of Brussels

Christophe Hotermans profile image

Christophe Hotermans

Alexion

Chief Medical Officer since 2021

MD, University of Leuven

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials
267
Recruited
141,000+
Dr. Alberto R. Martinez profile image

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Alexion Pharmaceuticals

Lead Sponsor

Trials
231
Recruited
36,700+
Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals

Chief Executive Officer since 2021

B.A. in Psychology from the University of New Hampshire

Christophe Hotermans profile image

Christophe Hotermans

Alexion Pharmaceuticals

Chief Medical Officer since 2023

MD

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