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Monoclonal Antibodies

Dupilumab for Eczema

Phase 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
For PFP Sub-Study Only: Must have received the same dupilumab dose regimen to be used in the PFP sub-study during the previous 12 weeks in the main OLE study using the prefilled syringe, as defined in the protocol
For PFP Sub-Study Only: Age ≥2 to <12 years at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 272
Awards & highlights

Study Summary

This trial is testing the long-term safety and efficacy of dupilumab, a medication used to treat eczema, in children. The trial will also assess the levels of functional dupilumab in the blood after repeated treatment and the immunogenicity of the medication.

Who is the study for?
This trial is for children aged ≥6 months to <18 years with Atopic Dermatitis (AD) who have participated in a prior dupilumab study. For the sub-study, only kids ≥2 to <12 years old and weighing between 5kg and 60kg can join. Participants must not have severe illnesses or recent treatments that could interfere with the study.Check my eligibility
What is being tested?
The main goal is to check long-term safety of dupilumab in young patients with AD. It also looks at how well it works over time, its levels in blood after repeated use, and if bodies react against it. A sub-study tests a pre-filled pen version for safety, dosage levels in blood, and immune response.See study design
What are the potential side effects?
While specific side effects are not listed here, generally Dupilumab may cause injection site reactions, eye issues like redness or itching, cold sores in mouth or throat area; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on the same dupilumab dose for the last 12 weeks as in the PFP study.
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I am between 2 and 11 years old, for the PFP study.
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My weight is between 5 kg and 60 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 272
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 272 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 at least one TEAE per participant year from baseline through the last study visit
Therapeutic procedure
OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study
+3 more
Secondary outcome measures
Annualize event rate of AD flares during the study
Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) for participants ≥4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed
+14 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB Period: Dupilumab
DB Period: Placebo
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: Body weight ≥60 kgExperimental Treatment1 Intervention
Administered every two weeks (Q2W)
Group II: Body weight 5 kg to <15 kgExperimental Treatment1 Intervention
Administered Q4W
Group III: Body weight 30 kg to <60 kgExperimental Treatment1 Intervention
Administered Q2W
Group IV: Body weight 15 kg to <30 kgExperimental Treatment1 Intervention
Administered every 4 weeks (Q4W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
378,579 Total Patients Enrolled
SanofiIndustry Sponsor
2,158 Previous Clinical Trials
3,513,468 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
249,819 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02612454 — Phase 3
Atopic Dermatitis Research Study Groups: Body weight 5 kg to <15 kg, Body weight ≥60 kg, Body weight 30 kg to <60 kg, Body weight 15 kg to <30 kg
Atopic Dermatitis Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT02612454 — Phase 3
Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02612454 — Phase 3

Frequently Asked Questions

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

What are some of the most well-known health conditions that Dupilumab can help with?

"Dupilumab is often used as an immunotherapy treatment for atopic dermatitis. It can also help patients who have corticosteroid-resistant asthma, eosinophilic asthma, and chronic spontaneous urticaria."

Answered by AI

Where can patients go to receive this treatment?

"Currently, this trial is being conducted in 47 different locations. Some of these places include Washington, Seattle and Philadelphia. There are also 47 other locations. When deciding on a clinic, please choose the one that is closest to your residence to minimize travel."

Answered by AI

What prior research has been conducted using Dupilumab?

"Dupilumab was first trialled in 2015 by Regeneron. To date, there have been 54 completed clinical trials with 53 more currently underway. Many of these active studies are situated in Washington, D.C."

Answered by AI

What are the US government's thoughts on Dupilumab?

"There is pre-existing evidence for Dupilumab's efficacy and safety from Phase 3 trials, resulting in a safety score of 3."

Answered by AI

Does this clinical trial set a precedent?

"As of now, there are 53 ongoing clinical trials for Dupilumab in 455 different cities and 43 countries. The first trial happened in 2015 and was completed in the Phase 3 stage of drug approval. Sanofi sponsored the trial which had 880 patients. In the 5 years since the first trial, 54 studies have been completed."

Answered by AI

Does this research allow for minors to participate?

"The recruitment process for this study requires that potential participants are above 6 months old and below 17 years of age."

Answered by AI

Are new participants currently being accepted into this research project?

"This study has completed recruitment and is no longer actively seeking patients. The study was posted on October 15th, 2015 and was last updated on July 26th, 2022. If you are seeking other studies, there are currently 255 studies actively looking for participants with eczema and 53 studies for Dupilumab admitting patients."

Answered by AI

Could you give me an estimate of how many individuals are included in this clinical trial?

"As of July 26th, 2022, this study is no longer recruiting patients. If you are interested in participating in a clinical trial, there are presently 255 trials actively looking for patients with eczema and 53 studies for Dupilumab that are actively searching for patients."

Answered by AI
Recent research and studies
~190 spots leftby Aug 2026