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Monoclonal Antibodies

ALXN1850 for Hypophosphatasia (HICKORY Trial)

Phase 3

Recruiting

Research Sponsored by Alexion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of HPP documented in the medical records

Documented ALPL gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (Section 8.7 )

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 169

Awards & highlights

HICKORY Trial Summary

This trial will test if a new drug can help improve the function of people with a rare metabolic bone disease.

Who is the study for?

This trial is for adolescents and adults with Hypophosphatasia (HPP) who have a documented ALPL gene variant, low serum alkaline phosphatase activity without other causes than HPP, high plasma PLP levels, and reduced walking capacity. They must not have been treated with asfotase alfa before. People with hypoparathyroidism unrelated to HPP, recent fractures or surgeries that could affect the study, allergies to ingredients in the treatment or placebo, or significant health issues affecting drug absorption or posing risks are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of a new medication called ALXN1850 compared to a placebo on improving physical function in participants with HPP. It's designed to see if those taking ALXN1850 perform better on functional tests like walking distance than those taking an inactive substance.See study design

What are the potential side effects?

While specific side effects for ALXN1850 aren't listed here, common side effects from similar treatments may include allergic reactions to ingredients, potential impact on organ functions due to genetic differences in metabolism of drugs, and general discomforts such as headaches or nausea.

HICKORY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My medical records show a diagnosis of HPP.

Select...

My test shows an ALPL gene variant from a certified lab.

Select...

I walked less than 85% of the expected distance for someone my age, sex, weight, and height due to HPP.

HICKORY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 169 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in 6-Minute Walk Test (6MWT) at the end of the Randomized Evaluation Period (Day 169)

Secondary outcome measures

Change from Baseline in 30-second Sit to Stand (STS) Test Score at the end of the Randomized Evaluation Period (Day 169)

Change from Baseline in Lower Extremity Functional Scale (LEFS) Score at the end of the Randomized Evaluation Period (Day 169)

Change from Baseline in Percent Predicted 6MWT at the end of the Randomized Evaluation Period (Day 169)

+4 more

HICKORY Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALXN1850 GroupExperimental Treatment2 Interventions

Starting at Day 1 of the Randomized Evaluation Period, the ALXN1850 group will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection, for 24 weeks. Participants will enter the OLE Period and continue q2w dosing with ALXN1850 for up to 132 weeks.

Group II: Placebo GroupPlacebo Group1 Intervention

During the Randomized Evaluation Period, the placebo group will receive placebo on Day 1, followed by once every 2 weeks (q2w) via SC injection for 24 weeks. Participants will enter the OLE Period and receive bodyweight dependent doses of either 20mg, 35mg, or 50mg of ALXN1850 and continue q2w dosing with ALXN1850 for up to 132 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

ALXN1850

2021

Completed Phase 1

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor

253 Previous Clinical Trials

41,088 Total Patients Enrolled

25 Trials studying Hypophosphatasia

1,498 Patients Enrolled for Hypophosphatasia

AlexionLead Sponsor

246 Previous Clinical Trials

39,163 Total Patients Enrolled

25 Trials studying Hypophosphatasia

1,498 Patients Enrolled for Hypophosphatasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be a suitable candidate for this experiment?

"In order to qualify for this medical trial, participants should have hypophosphatasia and range in age from 12-130. This study is seeking a total of 114 enrollees."

Answered by AI

Is the age limitation for this trial greater than 25 years?

"This medical trial is seeking patients aged 12 to 130 years old. However, there are two distinct studies for participants under 18 and another one designated for those over 65."

Answered by AI

Where can this clinical trial be accessed?

"Currently, 86 medical centres are accepting enrolment for this clinical study. These sites span from Baltimore to Boston and Saint Louis to many other cities. It is advised that potential participants select the closest location in order to limit their travel needs when participating."

Answered by AI

Has ALXN1850 Group been granted governmental sanction for its products?

"There is a plethora of clinical evidence that supports the safety of ALXN1850 Group, so it was assigned a score of 3."

Answered by AI

Are enrolment opportunities still available for this trial?

"According to information found on clinicaltrials.gov, this medical trial is not actively searching for participants as it was last updated in October 6th 2023. Nevertheless, two alternative studies are still recruiting patients at present time. This particular study first appeared on December 4th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079281.

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