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Atopic DermatitisPhase 3NCT02612454

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

A Phase 3 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 84 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are: To assess the long-term efficacy of dupilumab in pediatric participants with AD To assess the trough concentrations of functional dupilumab in serum and the… Read more about this study

Who is it for?
Ages 6 months to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
880 participants
Where
84 sitesin 7 countries
Study dates
15 Oct 2015to 9 Oct 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

84 sites in 7 countries.

84 sites in 7 countries

United States40 sites

  • Regeneron Investigational Site

    Bakersfield, California, 93309

  • Regeneron Investigational Site

    Bellaire, Texas, 77401-3505

  • Regeneron Investigational Site

    Birmingham, Alabama, 35209

  • Regeneron Investigational Site

    Boston, Massachusetts, 02115

  • Regeneron Investigational Site

    Boston, Massachusetts, 02116

  • Regeneron Investigational Site

    Centennial, Colorado, 80112

  • Regeneron Investigational Site

    Charleston, South Carolina, 29425

  • Regeneron Investigational Site

    Chicago, Illinois, 60611

  • Regeneron Investigational Site

    Columbus, Georgia, 31904

  • Regeneron Investigational Site

    Coral Gables, Florida, 33146

  • Regeneron Investigational Site

    Forest Hills, New York, 11375

  • Regeneron Investigational Site

    Fort Worth, Texas, 76244

  • Regeneron Investigational Site

    Gahanna, Ohio, 43230

  • Regeneron Investigational Site

    Gilbert, Arizona, 85234

  • Regeneron Investigational Site

    Long Beach, California, 90808

  • Regeneron Investigational Site

    Los Angeles, California, 90027

  • Regeneron Investigational Site

    Macon, Georgia, 31217

  • Regeneron Investigational site

    Mission Viejo, California, 92691

  • Regeneron Investigational Site

    New York, New York, 10029

  • Regeneron Investigational Site

    Norfolk, Virginia, 23502

  • Regeneron Investigational Site

    North Charleston, South Carolina, 29420

  • Regeneron Investigational Site

    Orange, California, 92868

  • Regeneron Investigational Site

    Palo Alto, California, 92304

  • Regeneron Investigational site

    Philadelphia, Pennsylvania, 19104

  • Regeneron Investigational site

    Plainfield, Indiana, 46168

  • Regeneron Investigational Site

    Plymouth, Minnesota, 55441

  • Regeneron Investigational Site

    Portland, Oregon, 97239

  • Regeneron Investigational Site

    Rochester, New York, 14642

  • Regeneron Investigational Site

    Rockville, Maryland, 20850

  • Regeneron Investigational Site

    Rolling Hills Estates, California, 90274

  • Regeneron Investigational Site

    San Antonio, Texas, 78218

  • Regeneron Investigational Site

    San Diego, California, 92123

  • Regeneron Investigational Site

    Sandy Springs, Georgia, 30328

  • Regeneron Investigational Site

    Seattle, Washington, 98105

  • Regeneron Investigational Site

    Skokie, Illinois, 60077

  • Regeneron Investigational Site

    St Louis, Missouri, 63104

  • Regeneron Investigational Site

    Tampa, Florida, 33613

  • Regeneron Investigational Site

    Tampa, Florida, 33624

  • Regeneron Investigational Site

    Washington D.C., District of Columbia, 20016

  • Regeneron Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland17 sites

  • Regeneron Investigational Site

    Bialystok, 15 453

  • Regeneron Investigational Site

    Bydgoszcz, 85-065

  • Regeneron Investigational Site

    Chorzów, 41-500

  • Regeneron Investigational Site

    Gdansk, 80-152

  • Regeneron Investigational Site

    Katowice, Silesian Voivodeship, 40-648

  • Regeneron Investigational Site

    Katowice, 40 611

  • Regeneron Investigational Site

    Krakow, Malopolska, 30 363

  • Regeneron Investigational Site

    Krakow, Malopolska, 31-011

  • Regeneron Investigational Site

    Krakow, 30 363

  • Regeneron Investigational Site

    Lodz, 90-265

  • Regeneron Investigational Site

    Ostrowiec Świętokrzyski, Kielce, 27-400

  • Regeneron Investigational Site

    Warsaw, 01-142

  • Regeneron Investigational Site

    Warsaw, 01-817

  • Regeneron Investigational Site

    Warsaw, 02-758

  • Regeneron Investigational Site

    Warsaw, 91-142

  • Regeneron Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • Regeneron Investigational Site

    Wroclaw, Lower Silesian Voivodeship, 50368

Other trials in Poland

Canada9 sites

  • Regeneron Investigational Site

    Calgary, Alberta, T2G 1B1

  • Regeneron Investigational Site

    Markham, Ontario, L3P 1X2

  • Regeneron Investigational Site

    Montreal, Quebec, H3T 1C5

  • Regeneron Investigational Site

    Ottawa, Ontario, K2C 2N3

  • Regeneron Investigational Site

    Peterborough, Ontario, K9J 5K2

  • Regeneron Investigational Site

    Surrey, British Columbia, V3R 6A7

  • Regeneron Investigational Site

    Waterloo, Ontario, N2J 1C4

  • Regeneron Investigational Site

    Windsor, Ontario, N8W 1E6

  • Regeneron Investigational Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Germany8 sites

  • Regeneron Investigational Site

    Dresden, Saxony, 01307

  • Regeneron Investigational Site

    Frankfurt am Main, Hesse, 60590

  • Regeneron Investigational Site

    Gera, 07548

  • Regeneron Investigational Site

    Hamburg, 22149

  • Regeneron Study Site

    München, 80802

  • Regeneron Investigational Site

    Munich, 80337

  • Regeneron Investigational Site

    Münster, North Rhine-Westphal, 48149

  • Regeneron Study Site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Hungary4 sites

  • Regeneron Investigational Site

    Kaposvár, 7400

  • Regeneron Investigational Site

    Miskolc, 3526

  • Regeneron Investigational Site

    Szeged, 6720

  • Regeneron Investigational Site

    Szolnok, Jász-Nagykun-Szolnok, 5000

Other trials in Hungary

Czechia3 sites

  • Regeneron Investigational Site

    Kutná Hora, 28401

  • Regeneron Investigational Site

    Prague, 10034

  • Regeneron Investigational Site

    Ústí nad Labem, 40113

Other trials in Czechia

United Kingdom3 sites

  • Regeneron Investigational Site

    London, Greater London, SE1 7EH

  • Regeneron Investigational Site

    Manchester, Lancashire, M13 9WL

  • Regeneron Investigational Site

    Sheffield, South Yorkshire, S10 2TH

Other trials in United Kingdom

About this study

Official title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.

The secondary objectives of the study are:

  • To assess the long-term efficacy of dupilumab in pediatric participants with AD
  • To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab

Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to <12 years of age with AD

Co-Primary Objectives are:

  • To evaluate the pharmacokinetic (PK) of dupilumab PFPs
  • To evaluate the safety of dupilumab PFPs

Secondary Objective is:

  • To evaluate the immunogenicity of dupilumab PFPs
Being tested
Dupilumab
Keywords
Eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called DUPIXENT®, REGN668, SAR231893

    Weight-tiered dosing administered subcutaneous (SC)

Study groups in NCT02612454
Study groupRoleWhat they receive
Body weight ≥60 kgExperimentalAdministered every two weeks (Q2W)
Receives: Drug: Dupilumab
Body weight 30 kg to <60 kgExperimentalAdministered Q2W
Receives: Drug: Dupilumab
Body weight 15 kg to <30 kgExperimentalAdministered every 4 weeks (Q4W)
Receives: Drug: Dupilumab
Body weight 5 kg to <15 kgExperimentalAdministered Q4W
Receives: Drug: Dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit

    Measured: Baseline up to week 272

  2. Number of participants with at least one TEAE per participant year from baseline through the last study visit

    Measured: Baseline up to week 272

  3. OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)

    Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

    Measured: Up to week 16

  4. OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)

    Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference)

    Measured: Up to week 16

  5. OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study

    Measured: Up to week 16

  6. OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study

    Measured: Up to week 16

Secondary outcomes (17)

  1. Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit

    Measured: Baseline up to week 272

  2. Incidence of TEAEs of special interest from baseline through the last study visit

    Measured: Baseline up to week 272

  3. Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  4. Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  5. Change from baseline in EASI score at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  6. Percent change from baseline in EASI at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  7. Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  8. Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline

    Measured: Baseline up to week 272

  9. 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

    Measured: Baseline up to week 272

  10. Change from baseline in Infants' Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed

    Measured: Baseline up to week 272

  11. Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period

    *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

    Measured: Baseline to week 260

  12. For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained

    *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

    Measured: Baseline to week 260

  13. Number of AD flares during the study

    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

    Measured: Baseline to week 272

  14. Annualize event rate of AD flares during the study

    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

    Measured: Baseline to week 272

  15. Proportion of participants with at least one flare during the study

    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

    Measured: Baseline to week 272

  16. Proportion of well-controlled weeks

    Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered

    Measured: Baseline to week 272

  17. OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study)

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study start15 Oct 2015
  3. Primary completion9 Oct 2026
  4. Study completion9 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02612454
Sponsor's protocol ID
R668-AD-1434
Other IDs
2015-001396-40, 2015
Status last verified
Oct 2026
First submitted
11 Nov 2015
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Paller AS, Siegfried EC, Bansal A, Xiao J, Khokhar FA, Van Spall M, Liu X, Xu C, Dubost-Brama A, Kosloski MP. Pharmacokinetics, efficacy and safety of dupilumab administered with prefilled pen devices in patients aged <12 years with atopic dermatitis. Br J Clin Pharmacol. 2026 Nov 4. doi: 10.1002/bcp.70895. Online ahead of print.

    PubMed 42980500

  • Paller AS, Pinter A, Wine Lee L, Aschoff R, Zdybski J, Schnopp C, Khokhar FA, Praestgaard AH, Bansal A, Shumel B, Bastian M. Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis. Paediatr Drugs. 2026 May;28(3):307-320. doi: 10.1007/s40272-026-00747-4. Epub 2026 Apr 2.

    PubMed 41926052

  • Paller AS, Simpson EL, Siegfried EC, Cork MJ, Arkwright PD, Pinter A, Deleuran M, Hong HC, Ma Y, Bansal A, Dubost-Brama A, Nguyen TV. Safety and Efficacy of Treatment with Dupilumab for up to 2 Years in Infants and Young Children with Atopic Dermatitis. Am J Clin Dermatol. 2026 May;27(3):611-620. doi: 10.1007/s40257-026-01018-1. Epub 2026 Mar 28.

    PubMed 41903092

  • Kamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024.

    PubMed 39588375

  • Paller AS, Siegfried EC, Simpson EL, Cork MJ, Sidbury R, Chen IH, Khokhar FA, Xiao J, Dubost-Brama A, Bansal A. Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study. Am J Clin Dermatol. 2024 Jul;25(4):655-668. doi: 10.1007/s40257-024-00859-y. Epub 2024 May 14.

    PubMed 38743155

  • Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Chen Z, Thomas RB, Kosloski MP, Dubost-Brama A, Prescilla R, Bansal A, Levit NA. Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2697-2719. doi: 10.1007/s13555-023-01016-9. Epub 2023 Sep 26.

    PubMed 37750994

  • Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14.

    PubMed 35567671

  • Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25.

    PubMed 34726270

  • Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1.

    PubMed 33481203

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab in people with Atopic Dermatitis, run by Regeneron Pharmaceuticals at 84 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Poland, Canada, Germany, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit (time frame: Baseline up to week 272). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02612454, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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