Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03346434
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
6 Months - 5 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Solution for injection, subcutaneous (SC)
  • Matching placebo — DRUG
    Solution for injection, subcutaneous (SC)

Study Details

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Nov 30, 2017
Status verified
Jul 2022
Primary completion
Jul 8, 2021
Completion
Jul 8, 2021

Study Design

Enrollment
202 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (Open label Dupilumab): Age cohorts 1 & 2
    Age cohort 1: ≥2 years old to \<6 years old Age cohort 2: ≥6 months to \<2 years old
  • Experimental: Part B (Double-blind): Dupilumab dose 1
    The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.
  • Experimental: Part B (Double-blind): Dupilumab dose 2
    The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.
  • Experimental: Part B (Double-Blind): Placebo

Primary Outcome Measure

Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab [ Time Frame: Post-dose on Days 1, 3, 8, 18, and 29 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Regeneron Investigational SiteBirminghamAlabama35209-
Regeneron Investigational SiteGilbertArizona85234-
Regeneron Investigational SiteLong BeachCalifornia90808-
Regeneron Investigational siteLos AngelesCalifornia90027-
Regeneron Investigational SitePalo AltoCalifornia94304-
Regeneron Investigational SiteRolling Hills EstatesCalifornia90274-
Regeneron Investigational SiteSan DiegoCalifornia92123-
Regeneron Investigational SiteWashington D.C.District of Columbia20010-
Regeneron Investigational SiteCoral GablesFlorida33146-
Regeneron Investigational SiteTampaFlorida33612-3807-
Regeneron Investigational SiteColumbusGeorgia31904-
Regeneron Investigational SiteMaconGeorgia31217-
Regeneron Investigational SiteSandy SpringsGeorgia39328-
Regeneron Investigational SiteChicagoIllinois60611-
Regeneron Investigational SiteRockvilleMaryland20850-
Regeneron Investigational SiteBostonMassachusetts02115-
Regeneron Investigational SiteAnn ArborMichigan48109-5314-
Regeneron Investigational SiteYpsilantiMichigan48197-
Regeneron Investigational SiteSt LouisMissouri63104-1003-
Regeneron Investigational SiteLincolnNebraska68505-
Regeneron Investigational SiteHackensackNew Jersey07601-
Regeneron Investigational SiteForest HillsNew York113756-
Regeneron Investigational SiteNew YorkNew York10032-
Regeneron Investigational SiteRochesterNew York14642-
Regeneron Investigational SitePortlandOregon97239-
Regeneron Investigational SitePhiladelphiaPennsylvania19104-
Regeneron Investigational SiteCharlestonSouth Carolina29425-
Regeneron Investigational SiteNorth CharlestonSouth Carolina29420-
Regeneron Investigational SiteAustinTexas78723-
Regeneron Investigational SiteSan AntonioTexas78218-
Regeneron Investigational SiteNorfolkVirginia23502-
Regeneron Investigational SiteSeattleWashington98105-
Regeneron Investigational SiteMilwaukeeWisconsin53226-

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Regeneron Investigational Site· Birmingham, ALRegeneron Investigational Site· Gilbert, AZRegeneron Investigational Site· Long Beach, CARegeneron Investigational site· Los Angeles, CARegeneron Investigational Site· Palo Alto, CARegeneron Investigational Site· Rolling Hills Estates, CA

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