Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02277769
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
Nov 30, 2014
Status verified
May 2020
Primary completion
Oct 31, 2015
Completion
Jan 31, 2016

Study Design

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

Arms

  • Placebo Comparator: 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 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.
  • Experimental: Dupilumab 300 mg 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.

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 (53)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama--
-BirminghamAlabama--
-PhoenixArizona--
-BakersfieldCalifornia--
-Costa MesaCalifornia--
-FremontCalifornia--
-Long BeachCalifornia--
-Los AngelesCalifornia--
-OrangeCalifornia--
-RosevilleCalifornia--
-TemeculaCalifornia--
-TrumbullConnecticut--
-MiamiFlorida--
-OviedoFlorida--
-TampaFlorida--
-West Palm BeachFlorida--
-AlpharettaGeorgia--
-AtlantaGeorgia--
-ColumbusGeorgia--
-Buffalo GroveIllinois--
-PlainfieldIndiana--
-West Des MoinesIowa--
-Overland ParkKansas--
-RockvilleMaryland--
-Washington ParkMaryland--
-BostonMassachusetts--
-Farmington HillsMichigan--
-MinneapolisMinnesota--
-PlymouthMinnesota--
-Saint JosephMissouri--
-St LouisMissouri--
-BillingsMontana--
-BozemanMontana--
-Las VegasNevada--
-VeronaNew Jersey--
-Forest HillsNew York--
-New YorkNew York--
-SmithtownNew York--
-Chapel HillNorth Carolina--
-RaleighNorth Carolina--
-WilmingtonNorth Carolina--
-Winston-SalemNorth Carolina--
-TulsaOklahoma--
-PortlandOregon--
-JenkintownPennsylvania--
-GreerSouth Carolina--
-ArlingtonTexas--
-AustinTexas--
-BellaireTexas--
-HoustonTexas--
-San AntonioTexas--
-RichmondVirginia--
-SeattleWashington--

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