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Eczema drug dupilumab tested for Long-Term use in kids

NCT ID NCT02612454

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at the long-term safety of dupilumab (Dupixent) in children aged 6 months to 18 years with atopic dermatitis (eczema). About 880 kids who were in earlier dupilumab studies will continue treatment. Researchers will track side effects and check if a pre-filled pen works as well as a syringe. The goal is to see if the drug remains safe and effective over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If successful, this could confirm that dupilumab is safe and effective for long-term use in children with eczema, offering a reliable treatment option.
What could go wrong
This is an open-label extension study, meaning everyone knows they are getting the drug, which can bias results. Long-term side effects are still being monitored, and the study may not prove the drug works better than no treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

880 people

The number who actually took part.

Started

Oct 2015

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participated in a prior dupilumab study in pediatric participants with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol * PFP Sub-Study Only: * Age ≥2 to \<12 years at time of screening * Body weight ≥5 kg and \<60 kg at time of screening * 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 Key Exclusion Criteria: * Participants who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient * Participants, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient * Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit * Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit * Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit * Diagnosed active endoparasitic infections or at high risk of these infections * Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study * PFP Sub-study Only: * Poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main OLE study prior to entering the sub-study * Switched dupilumab doses within the past 12 weeks * Meet criteria for temporary/permanent discontinuation of study drug at time of screening into PFP sub-study, as defined in the protocol. Note: Other protocol defined Inclusion / Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Regeneron Investigational Site

    Birmingham, Alabama, 35209, United States

  • Regeneron Investigational Site

    Gilbert, Arizona, 85234, United States

  • Regeneron Investigational Site

    Bakersfield, California, 93309, United States

  • Regeneron Investigational Site

    Long Beach, California, 90808, United States

  • Regeneron Investigational Site

    Los Angeles, California, 90027, United States

  • Regeneron Investigational Site

    Orange, California, 92868, United States

  • Regeneron Investigational Site

    Palo Alto, California, 92304, United States

  • Regeneron Investigational Site

    Rolling Hills Estates, California, 90274, United States

  • Regeneron Investigational Site

    San Diego, California, 92123, United States

  • Regeneron Investigational Site

    Centennial, Colorado, 80112, United States

  • Regeneron Investigational Site

    Washington D.C., District of Columbia, 20016, United States

  • Regeneron Investigational Site

    Coral Gables, Florida, 33146, United States

  • Regeneron Investigational Site

    Tampa, Florida, 33613, United States

  • Regeneron Investigational Site

    Tampa, Florida, 33624, United States

  • Regeneron Investigational Site

    Columbus, Georgia, 31904, United States

  • Regeneron Investigational Site

    Macon, Georgia, 31217, United States

  • Regeneron Investigational Site

    Sandy Springs, Georgia, 30328, United States

  • Regeneron Investigational Site

    Chicago, Illinois, 60611, United States

  • Regeneron Investigational Site

    Skokie, Illinois, 60077, United States

  • Regeneron Investigational Site

    Rockville, Maryland, 20850, United States

  • Regeneron Investigational Site

    Boston, Massachusetts, 02115, United States

  • Regeneron Investigational Site

    Boston, Massachusetts, 02116, United States

  • Regeneron Investigational Site

    Ypsilanti, Michigan, 48197, United States

  • Regeneron Investigational Site

    Plymouth, Minnesota, 55441, United States

  • Regeneron Investigational Site

    St Louis, Missouri, 63104, United States

  • Regeneron Investigational Site

    Forest Hills, New York, 11375, United States

  • Regeneron Investigational Site

    New York, New York, 10029, United States

  • Regeneron Investigational Site

    Rochester, New York, 14642, United States

  • Regeneron Investigational Site

    Gahanna, Ohio, 43230, United States

  • Regeneron Investigational Site

    Portland, Oregon, 97239, United States

  • Regeneron Investigational Site

    Charleston, South Carolina, 29425, United States

  • Regeneron Investigational Site

    North Charleston, South Carolina, 29420, United States

  • Regeneron Investigational Site

    Bellaire, Texas, 77401-3505, United States

  • Regeneron Investigational Site

    Fort Worth, Texas, 76244, United States

  • Regeneron Investigational Site

    San Antonio, Texas, 78218, United States

  • Regeneron Investigational Site

    Norfolk, Virginia, 23502, United States

  • Regeneron Investigational Site

    Seattle, Washington, 98105, United States

  • Regeneron Investigational Site

    Calgary, Alberta, T2G 1B1, Canada

  • Regeneron Investigational Site

    Surrey, British Columbia, V3R 6A7, Canada

  • Regeneron Investigational Site

    Winnipeg, Manitoba, R3C 0N2, Canada

  • Regeneron Investigational Site

    Markham, Ontario, L3P 1X2, Canada

  • Regeneron Investigational Site

    Ottawa, Ontario, K2C 2N3, Canada

  • Regeneron Investigational Site

    Peterborough, Ontario, K9J 5K2, Canada

  • Regeneron Investigational Site

    Waterloo, Ontario, N2J 1C4, Canada

  • Regeneron Investigational Site

    Windsor, Ontario, N8W 1E6, Canada

  • Regeneron Investigational Site

    Montreal, Quebec, H3T 1C5, Canada

  • Regeneron Investigational Site

    Kutná Hora, 28401, Czechia

  • Regeneron Investigational Site

    Prague, 10034, Czechia

  • Regeneron Investigational Site

    Ústí nad Labem, 40113, Czechia

  • Regeneron Investigational Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Regeneron Investigational Site

    Münster, North Rhine-Westphal, 48149, Germany

  • Regeneron Investigational Site

    Dresden, Saxony, 01307, Germany

  • Regeneron Investigational Site

    Gera, 07548, Germany

  • Regeneron Investigational Site

    Hamburg, 22149, Germany

  • Regeneron Investigational Site

    Munich, 80337, Germany

  • Regeneron Investigational Site

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • Regeneron Investigational Site

    Kaposvár, 7400, Hungary

  • Regeneron Investigational Site

    Miskolc, 3526, Hungary

  • Regeneron Investigational Site

    Szeged, 6720, Hungary

  • Regeneron Investigational Site

    Ostrowiec Świętokrzyski, Kielce, 27-400, Poland

  • Regeneron Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

  • Regeneron Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50368, Poland

  • Regeneron Investigational Site

    Krakow, Malopolska, 30 363, Poland

  • Regeneron Investigational Site

    Krakow, Malopolska, 31-011, Poland

  • Regeneron Investigational Site

    Katowice, Silesian Voivodeship, 40-648, Poland

  • Regeneron Investigational Site

    Bialystok, 15 453, Poland

  • Regeneron Investigational Site

    Bydgoszcz, 85-065, Poland

  • Regeneron Investigational Site

    Chorzów, 41-500, Poland

  • Regeneron Investigational Site

    Gdansk, 80-152, Poland

  • Regeneron Investigational Site

    Katowice, 40 611, Poland

  • Regeneron Investigational Site

    Krakow, 30 363, Poland

  • Regeneron Investigational Site

    Lodz, 90-265, Poland

  • Regeneron Investigational Site

    Warsaw, 01-142, Poland

  • Regeneron Investigational Site

    Warsaw, 01-817, Poland

  • Regeneron Investigational Site

    Warsaw, 02-758, Poland

  • Regeneron Investigational Site

    Warsaw, 91-142, Poland

  • Regeneron Investigational Site

    London, Greater London, SE1 7EH, United Kingdom

  • Regeneron Investigational Site

    Manchester, Lancashire, M13 9WL, United Kingdom

  • Regeneron Investigational Site

    Sheffield, South Yorkshire, S10 2TH, United Kingdom

  • Regeneron Investigational site

    Mission Viejo, California, 92691, United States

  • Regeneron Investigational site

    Plainfield, Indiana, 46168, United States

  • Regeneron Investigational site

    Philadelphia, Pennsylvania, 19104, United States

  • Regeneron Study Site

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Regeneron Study Site

    München, 80802, Germany

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