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Monoclonal Antibodies

Pozelimab for Protein-Losing Enteropathy

Q: Have similar tests been conducted previously with this same medication?

<p>Since the completion of its Phase 2 &#x26; 3 in 2020, there have been 6 active trials for Pozelimab across 18 countries and 40 cities.</p>

Phase 2 & 3

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

Awards & highlights

Study Summary

This trial is testing a new drug, pozelimab, for a protein-losing enteropathy called CHAPLE. The study will look at the effect of the drug on the disease, safety, and quality of life.

Who is the study for?

This trial is for patients with a condition called CD55-deficient Protein-Losing Enteropathy (CHAPLE Disease). Participants must have a clinical diagnosis confirmed by genetic testing and either be currently experiencing symptoms or on eculizumab therapy but willing to switch to pozelimab.Check my eligibility

What is being tested?

The study aims to test the effectiveness and safety of a drug named Pozelimab in treating CHAPLE Disease. It will look at how well it manages symptoms, improves quality of life, affects lab values like albumin levels, reduces hospital stays, and impacts growth among other factors.See study design

What are the potential side effects?

While specific side effects are not listed here, the trial will monitor how patients tolerate Pozelimab. This includes any adverse reactions they might have during treatment as well as changes in their overall health.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with CD55-deficient PLE/CHAPLE disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants With Active Disease at Baseline Who Achieved Normalization of Serum Albumin and Improvement in Prespecified Clinical Outcomes at Week 24

Secondary outcome measures

Absolute Value of Total Albumin at Specified Timepoints

Absolute Values of Total Ferritin at Baseline and Week 24

Absolute Values of Total Immunoglobulin (Ig), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) at Baseline and Week 24

+63 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active PLEExperimental Treatment1 Intervention

Patients aged 1 year and older with a clinical diagnosis of CD55-deficient PLE disease

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pozelimab

2020

Completed Phase 2

~120

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,837 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

251,034 Total Patients Enrolled

Media Library

Pozelimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04209634 — Phase 2 & 3

Protein-Losing Enteropathy Research Study Groups: Active PLE

Protein-Losing Enteropathy Clinical Trial 2023: Pozelimab Highlights & Side Effects. Trial Name: NCT04209634 — Phase 2 & 3

Pozelimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209634 — Phase 2 & 3

Frequently Asked Questions

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

Have similar tests been conducted previously with this same medication?

"Since the completion of its Phase 2 & 3 in 2020, there have been 6 active trials for Pozelimab across 18 countries and 40 cities."

Answered by AI

How many people will be included in this research project?

"This particular study has completed recruitment for its clinical trial. While it was first posted on 1/27/2020, the most recent update was on 11/8/2022. However, there are 134 other trials regarding protein-losing enteropathies and 6 for Pozelimab that are currently looking for patients."

Answered by AI

Are patients still being recruited for this clinical trial?

"This research project is no longer looking for volunteers. The trial was first posted on January 27th, 2020 and edited November 8th, 2022. There are presently 134 trials actively recruiting patients with protein-losing enteropathies and 6 Pozelimab studies still searching for participants."

Answered by AI

Is this the first time Pozelimab has been used in a research setting?

"There are currently six ongoing clinical trials for Pozelimab. Four of those studies are in Phase III, which is the last stage before FDA approval can be sought. Most of the trial locations for Pozelimab are situated in Whittier, California; however, there are a total of 64 research centres running these experiments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)

2020. "Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04209634.