Undersøgelse for at vurdere den langsigtede sikkerhed af Dupilumab administreret hos deltagere ≥6 måneder til
2. november 2026 opdateret af: Regeneron Pharmaceuticals
Et åbent udvidelsesstudie for at vurdere langsigtet sikkerhed og effektivitet af Dupilumab hos patienter ≥6 måneder til
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
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
880
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2G 1B1
- Regeneron Investigational Site
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British Columbia
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Surrey, British Columbia, Canada, V3R 6A7
- Regeneron Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
- Regeneron Investigational Site
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Ontario
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Markham, Ontario, Canada, L3P 1X2
- Regeneron Investigational Site
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Ottawa, Ontario, Canada, K2C 2N3
- Regeneron Investigational Site
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Peterborough, Ontario, Canada, K9J 5K2
- Regeneron Investigational Site
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Waterloo, Ontario, Canada, N2J 1C4
- Regeneron Investigational Site
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Windsor, Ontario, Canada, N8W 1E6
- Regeneron Investigational Site
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Regeneron Investigational Site
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Greater London
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London, Greater London, Det Forenede Kongerige, SE1 7EH
- Regeneron Investigational Site
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Lancashire
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Manchester, Lancashire, Det Forenede Kongerige, M13 9WL
- Regeneron Investigational Site
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South Yorkshire
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Sheffield, South Yorkshire, Det Forenede Kongerige, S10 2TH
- Regeneron Investigational Site
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- Regeneron Investigational Site
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Regeneron Investigational Site
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California
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Bakersfield, California, Forenede Stater, 93309
- Regeneron Investigational Site
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Long Beach, California, Forenede Stater, 90808
- Regeneron Investigational Site
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Los Angeles, California, Forenede Stater, 90027
- Regeneron Investigational Site
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Mission Viejo, California, Forenede Stater, 92691
- Regeneron Investigational site
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Orange, California, Forenede Stater, 92868
- Regeneron Investigational Site
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Palo Alto, California, Forenede Stater, 92304
- Regeneron Investigational Site
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Rolling Hills Estates, California, Forenede Stater, 90274
- Regeneron Investigational Site
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San Diego, California, Forenede Stater, 92123
- Regeneron Investigational Site
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
- Regeneron Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Regeneron Investigational Site
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Florida
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Coral Gables, Florida, Forenede Stater, 33146
- Regeneron Investigational Site
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Tampa, Florida, Forenede Stater, 33613
- Regeneron Investigational Site
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Tampa, Florida, Forenede Stater, 33624
- Regeneron Investigational Site
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Georgia
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Columbus, Georgia, Forenede Stater, 31904
- Regeneron Investigational Site
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Macon, Georgia, Forenede Stater, 31217
- Regeneron Investigational Site
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Sandy Springs, Georgia, Forenede Stater, 30328
- Regeneron Investigational Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Regeneron Investigational Site
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Skokie, Illinois, Forenede Stater, 60077
- Regeneron Investigational Site
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Indiana
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Plainfield, Indiana, Forenede Stater, 46168
- Regeneron Investigational site
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Regeneron Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Regeneron Investigational Site
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Boston, Massachusetts, Forenede Stater, 02116
- Regeneron Investigational Site
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Michigan
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Ypsilanti, Michigan, Forenede Stater, 48197
- Regeneron Investigational Site
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Minnesota
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Plymouth, Minnesota, Forenede Stater, 55441
- Regeneron Investigational Site
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Missouri
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St Louis, Missouri, Forenede Stater, 63104
- Regeneron Investigational Site
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New York
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Forest Hills, New York, Forenede Stater, 11375
- Regeneron Investigational Site
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New York, New York, Forenede Stater, 10029
- Regeneron Investigational Site
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Rochester, New York, Forenede Stater, 14642
- Regeneron Investigational Site
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Ohio
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Gahanna, Ohio, Forenede Stater, 43230
- Regeneron Investigational Site
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Regeneron Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Regeneron Investigational site
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Regeneron Investigational Site
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North Charleston, South Carolina, Forenede Stater, 29420
- Regeneron Investigational Site
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Texas
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Bellaire, Texas, Forenede Stater, 77401-3505
- Regeneron Investigational Site
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Fort Worth, Texas, Forenede Stater, 76244
- Regeneron Investigational Site
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San Antonio, Texas, Forenede Stater, 78218
- Regeneron Investigational Site
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Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Regeneron Investigational Site
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Regeneron Investigational Site
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Bialystok, Polen, 15 453
- Regeneron Investigational Site
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Bydgoszcz, Polen, 85-065
- Regeneron Investigational Site
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Chorzów, Polen, 41-500
- Regeneron Investigational Site
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Gdansk, Polen, 80-152
- Regeneron Investigational Site
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Katowice, Polen, 40 611
- Regeneron Investigational Site
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Krakow, Polen, 30 363
- Regeneron Investigational Site
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Lodz, Polen, 90-265
- Regeneron Investigational Site
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Warsaw, Polen, 01-142
- Regeneron Investigational Site
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Warsaw, Polen, 01-817
- Regeneron Investigational Site
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Warsaw, Polen, 02-758
- Regeneron Investigational Site
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Warsaw, Polen, 91-142
- Regeneron Investigational Site
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Kielce
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Ostrowiec Świętokrzyski, Kielce, Polen, 27-400
- Regeneron Investigational Site
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
- Regeneron Investigational Site
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Wroclaw, Lower Silesian Voivodeship, Polen, 50368
- Regeneron Investigational Site
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Malopolska
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Krakow, Malopolska, Polen, 31-011
- Regeneron Investigational Site
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Krakow, Malopolska, Polen, 30 363
- Regeneron Investigational Site
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Silesian Voivodeship
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Katowice, Silesian Voivodeship, Polen, 40-648
- Regeneron Investigational Site
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Kutná Hora, Tjekkiet, 28401
- Regeneron Investigational Site
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Prague, Tjekkiet, 10034
- Regeneron Investigational Site
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Ústí nad Labem, Tjekkiet, 40113
- Regeneron Investigational Site
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Gera, Tyskland, 07548
- Regeneron Investigational Site
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Hamburg, Tyskland, 22149
- Regeneron Investigational Site
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Munich, Tyskland, 80337
- Regeneron Investigational Site
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München, Tyskland, 80802
- Regeneron Study Site
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Baden-Wurttemberg
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Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Regeneron Study Site
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Hesse
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Frankfurt am Main, Hesse, Tyskland, 60590
- Regeneron Investigational Site
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North Rhine-Westphal
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Münster, North Rhine-Westphal, Tyskland, 48149
- Regeneron Investigational Site
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Regeneron Investigational Site
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Kaposvár, Ungarn, 7400
- Regeneron Investigational Site
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Miskolc, Ungarn, 3526
- Regeneron Investigational Site
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Szeged, Ungarn, 6720
- Regeneron Investigational Site
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Jász-Nagykun-Szolnok
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Szolnok, Jász-Nagykun-Szolnok, Ungarn, 5000
- Regeneron Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
6 måneder til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
4
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Body weight ≥60 kg
Administered every two weeks (Q2W) |
Weight-tiered dosing administered subcutaneous (SC)
Andre navne:
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Eksperimentel: Body weight 30 kg to <60 kg
Administered Q2W |
Weight-tiered dosing administered subcutaneous (SC)
Andre navne:
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Eksperimentel: Body weight 15 kg to <30 kg
Administered every 4 weeks (Q4W) |
Weight-tiered dosing administered subcutaneous (SC)
Andre navne:
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Eksperimentel: Body weight 5 kg to <15 kg
Administered Q4W |
Weight-tiered dosing administered subcutaneous (SC)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hyppighed af behandlingsfremkomne bivirkninger (TEAE) pr. deltagerår fra baseline til det sidste studiebesøg
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Antal deltagere med mindst én TEAE pr. deltagerår fra baseline til det sidste studiebesøg
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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VALGFRI DELUNDERSØGELSE: Forekomst af TEAE'er under den 12-ugers PFP-behandlingsperiode og under hele delstudiet
Tidsramme: Op til uge 16
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Op til uge 16
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VALGFRI DELUNDERSØGELSE: Forekomst af SAE'er under den 12-ugers PFP-behandlingsperiode og under hele delstudiet
Tidsramme: Op til uge 16
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Op til uge 16
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OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax)
Tidsramme: Up to week 16
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Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) |
Up to week 16
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OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough)
Tidsramme: Up to week 16
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Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) |
Up to week 16
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antallet af behandlingsfremkaldte alvorlige bivirkninger (SAE'er) fra baseline til det sidste studiebesøg
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Forekomst af TEAE'er af særlig interesse fra baseline til det sidste studiebesøg
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Andel af deltagere med en Investigator Global Assessment (IGA)-score på 0 eller 1 (klar eller næsten klar) ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Andel af deltagere med Eczema Area and Severity Index (EASI)-75 (≥75 % reduktion i EASI fra baseline af forældreundersøgelsen) respons ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Ændring fra baseline i EASI-score ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Procentvis ændring fra baseline i EASI ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Ændring fra baseline i kropsoverfladeareal (BSA) påvirket af AD (BSA) ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
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Baseline op til uge 272
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Procentvis ændring fra baseline i SCORing atopisk dermatitis (SCORAD) ved alle klinikbesøg efter baseline
Tidsramme: Baseline op til uge 272
|
Baseline op til uge 272
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Ændring fra baseline i Children's Dermatology Life Quality Index (CDLQI) for deltagere ≥4 år ved alle klinikbesøg efter baseline, hvor vurderingerne er planlagt til at blive udført
Tidsramme: Baseline op til uge 272
|
Baseline op til uge 272
|
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Ændring fra baseline i Infants' Dermatology Quality of Life Index (IDQOL) for deltagere <4 år ved alle klinikbesøg efter baseline, hvor vurderingerne er planlagt til at blive udført
Tidsramme: Baseline op til uge 272
|
Baseline op til uge 272
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VALGFRI DELUNDERSØGELSE: Forekomst og titer af behandlingsfremkomne anti-lægemiddelantistoffer (ADA) (PFP-underundersøgelse)
Tidsramme: Op til 16 uger
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Op til 16 uger
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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
Tidsramme: Baseline to week 260
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*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved. |
Baseline to week 260
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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
Tidsramme: Baseline to week 260
|
*Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved. |
Baseline to week 260
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Number of AD flares during the study
Tidsramme: Baseline to week 272
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AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment |
Baseline to week 272
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Annualize event rate of AD flares during the study
Tidsramme: Baseline to week 272
|
AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment |
Baseline to week 272
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Proportion of participants with at least one flare during the study
Tidsramme: Baseline to week 272
|
AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment |
Baseline to week 272
|
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Proportion of well-controlled weeks
Tidsramme: Baseline to week 272
|
Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered |
Baseline to week 272
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
15. oktober 2015
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
9. oktober 2026
Studieafslutning (Faktiske)
Studieafslutning
9. oktober 2026
Datoer for studieregistrering
Først indsendt
Først indsendt
11. november 2015
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
19. november 2015
Først opslået (Anslået)
Først opslået
23. november 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- R668-AD-1434
- 2015-001396-40 (EudraCT nummer)
- 2015 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .