Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02210780
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Administered via subcutaneous injection.
  • Placebo — DRUG
    An inactive substance containing no medicine administered via subcutaneous injection.

Study Details

This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab.

Key Dates

Start date
Aug 5, 2014
Status verified
Apr 2020
Primary completion
Sep 15, 2015
Completion
Sep 15, 2015

Study Design

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

Arms

  • Experimental: Placebo qw
    Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection 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 qw from Week 1 to Week 15.

Primary Outcome Measure

Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 [ Time Frame: Week 16 ]

Locations (42)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Fort SmithArkansas--
-Long BeachCalifornia--
-Los AngelesCalifornia--
-Mission ViejoCalifornia--
-Rolling Hills EstatesCalifornia--
-San DiegoCalifornia--
-Santa MonicaCalifornia--
-DenverColorado--
-JacksonvilleFlorida--
-MiamiFlorida--
-TampaFlorida--
-MaconGeorgia--
-ChicagoIllinois--
-MaywoodIllinois--
-West DundeeIllinois--
-IndianapolisIndiana--
-PlainfieldIndiana--
-Overland ParkKansas--
-BostonMassachusetts--
-Ann ArborMichigan--
-TroyMichigan--
-St LouisMissouri--
-HackensackNew Jersey--
-AlbuquerqueNew Mexico--
-BuffaloNew York--
-Forest HillsNew York--
-New YorkNew York--
-ClevelandOhio--
-NormanOklahoma--
-TulsaOklahoma--
-MedfordOregon--
-PortlandOregon--
-PittsburghPennsylvania--
-CharlestonSouth Carolina--
-GreerSouth Carolina--
-ArlingtonTexas--
-AustinTexas--
-HoustonTexas--
-WebsterTexas--
-RichmondVirginia--
-SeattleWashington--

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease

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