Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02277743
Phase
PHASE3
Status
Completed

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms
  • Placebo (for Dupilumab) — DRUG
    Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms

Study Details

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Oct 31, 2014
Status verified
Nov 2017
Primary completion
Nov 30, 2015
Completion
Feb 29, 2016

Study Design

Enrollment
671 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo
    Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.
  • Experimental: Dupilumab 300 mg once weekly (qw)
    Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
  • Experimental: Dupilumab 300 mg every 2 weeks (q2w)
    Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.

Primary Outcome Measure

Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 [ Time Frame: Week 16 ]

Locations (45)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Fort SmithArkansas--
-RogersArkansas--
-ClovisCalifornia--
-LomitaCalifornia--
-Los AngelesCalifornia--
-OceansideCalifornia--
-PalmdaleCalifornia--
-Rolling Hills EstatesCalifornia--
-San DiegoCalifornia--
-Santa MonicaCalifornia--
-StocktonCalifornia--
-Boca RatonFlorida--
-ClearwaterFlorida--
-Fort LauderdaleFlorida--
-MiamiFlorida--
-Miami LakesFlorida--
-PensacolaFlorida--
-TampaFlorida--
-NewnanGeorgia--
-ChicagoIllinois--
-NormalIllinois--
-EvansvilleIndiana--
-IndianapolisIndiana--
-LouisvilleKentucky--
-BostonMassachusetts--
-TroyMichigan--
-St LouisMissouri--
-NewingtonNew Hampshire--
-East WindsorNew Jersey--
-BuffaloNew York--
-CorningNew York--
-New Hyde ParkNew York--
-RochesterNew York--
-High PointNorth Carolina--
-BethlehemPennsylvania--
-UplandPennsylvania--
-ChattanoogaTennessee--
-KnoxvilleTennessee--
-San AntonioTexas--
-WacoTexas--
-OgdenUtah--
-Newport NewsVirginia--
-NorfolkVirginia--
-SpokaneWashington--

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