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Monoclonal Antibodies

ALXN1850 for Hypophosphatasia (CHESTNUT 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

Tanner stage 2 or less during the Screening Period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 169

Awards & highlights

CHESTNUT Trial Summary

This trial will test if a new medication is safe and effective for children with a rare bone disease.

Who is the study for?

This trial is for children with Hypophosphatasia (HPP) who are in early puberty or younger, have open growth plates, and have been treated with asfotase alfa for at least 6 months. They must weigh over 10 kg and not have had a new fracture recently. Kids can't join if they've had certain other health problems or surgeries that might affect the study, or if they're allergic to ingredients in the treatments.Check my eligibility

What is being tested?

The trial is testing ALXN1850 against asfotase alfa to see which one is safer and more tolerable for kids with HPP who've already tried asfotase alfa. It's a Phase 3 study where participants will be randomly assigned to receive either ALXN1850 or continue their current treatment of asfotase alfa.See study design

What are the potential side effects?

Possible side effects from ALXN1850 could include reactions similar to those experienced with asfotase alfa since both drugs treat HPP. These may involve issues at the injection site, allergic reactions, or complications related to the conditions being treated.

CHESTNUT 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 physical development is at or before early puberty.

Select...

I have been treated with asfotase alfa for at least 6 months.

CHESTNUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 169

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 169

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Secondary outcome measures

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

Change from Baseline in Bruininks Oseretsky Test of Motor Proficiency, Second Edition (BOT2) Score at the end of the Randomized Evaluation Period (Day 169)

Change from Baseline in Peabody Developmental Motor Scales, Third Edition (PDMS-3) Score at the end of the Randomized Evaluation Period (Day 169)

+3 more

CHESTNUT Trial Design

2Treatment groups

Experimental Treatment

Group I: asfotase alfaExperimental Treatment1 Intervention

Starting at Day 1 of the Randomized Evaluation Period, participants will receive asfotase alfa for a total of 24 weeks. Participants will receive 6 mg/kg/week of asfotase alfa via SC injection as either 2 mg/kg 3 times per week or 1 mg/kg 6 times per week. Part A of the OLE Period participants will have frequent visits over the first 24 weeks; Part B will have visits every 9 months for up to approximately 108 weeks.

Group II: ALXN1850Experimental Treatment2 Interventions

Starting at Day 1 of the Randomized Evaluation Period participants will receive ALXN1850 for a total of 24 weeks. Participants will receive bodyweight dependent doses of either 20mg, 35mg or 50mg of ALXN1850 once q2w via SC injection. During Part A of the OLE Period, participants will have frequent visits over the first 24 weeks; Part B of the OLE Period participants will have visits every 9 months for up to approximately 108 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALXN1850

2021

Completed Phase 1

~20

asfotase alfa

2008

Completed Phase 3

~130

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor

253 Previous Clinical Trials

41,165 Total Patients Enrolled

25 Trials studying Hypophosphatasia

1,572 Patients Enrolled for Hypophosphatasia

AlexionLead Sponsor

246 Previous Clinical Trials

39,240 Total Patients Enrolled

25 Trials studying Hypophosphatasia

1,572 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.

Is this experiment inviting seniors to participate?

"According to the stated requirements, eligible participants must be between 2 and 11 years old."

Answered by AI

Are there any deleterious effects of taking ALXN1850?

"According to our assessment, ALXN1850's safety is rated at 3 because of the pre-existing evidence that supports its efficacy and multiple clinical trials attesting to its security."

Answered by AI

Could I qualify to be included in this research project?

"The current clinical trial for hypophosphatasia treatment is accepting 30 participants between the ages of two and eleven."

Answered by AI

How many locations are hosting this clinical investigation?

"At present, this clinical trial has 29 sites across the United States. These include Baltimore, Boston and Minneapolis among other cities. Therefore, it is wise to choose a location nearby in order to reduce travel costs when participating in the study."

Answered by AI

Are new participants being accepted for this experiment?

"Per the information displayed on clinicaltrials.gov, this particular medical trial has ceased recruiting participants; it was initially posted on November 16th 2023 and its last update occurred October 6th 2023. Alternatively, there are presently 4 other trials that remain open for new enrollees."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

2024. "Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079372.

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