Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

Recruiting at 5 trial locations

Overseen By Alexion Pharmaceuticals, Inc.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Alexion

Must not be taking: Asfotase alfa

Disqualifiers: Hyperparathyroidism, Hypoparathyroidism, Fracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ALXN1850

How Is the Trial Designed?

Group I: ALXN1850 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Alexion

Lead Sponsor

Trials

247

Recruited

38,600+

Marc Dunoyer

Alexion

Chief Executive Officer since 2021

PhD in Molecular Biology, University of Brussels

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

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

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

Alexion Pharmaceuticals

Chief Executive Officer since 2021

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

Christophe Hotermans

Alexion Pharmaceuticals

Chief Medical Officer since 2023

MD