Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03736967
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • REGN3500 — DRUG
    Administered subcutaneous (SC) every 2 weeks (q2w)
  • Dupilumab — DRUG
    Administered SC q2w
  • REGN3500 + Dupilumab Combo — DRUG
    Administered SC q2w
  • Placebo — DRUG
    Administered SC q2w

Study Details

The primary objective of the study is to evaluate the efficacy of REGN3500 monotherapy compared with placebo treatment in adult patients with moderate-to-severe Atopic dermatitis (AD). Secondary Objectives are to: * Evaluate the efficacy of REGN3500 in combination with dupilumab compared with placebo treatment in adult patients with moderate-to-severe AD * Assess the safety, tolerability, and immunogenicity of subcutaneous (SC) doses of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD * Evaluate the Pharmacokinetic (PK) of REGN3500 monotherapy and REGN3500 in combination with dupilumab in adult patients with moderate-to-severe AD

Key Dates

Start date
Nov 12, 2018
Status verified
Oct 2021
Primary completion
Mar 13, 2020
Completion
Jul 28, 2020

Study Design

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

Arms

  • Experimental: REGN3500
  • Experimental: Dupilumab
  • Experimental: Combo
  • Experimental: Placebo

Primary Outcome Measure

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 [ Time Frame: Week 16 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Regeneron Research SitePhoenixArizona85259-
Regeneron Research SiteFountain ValleyCalifornia92708-
Regeneron Research SiteLong BeachCalifornia90808-
Regeneron Research SiteLos AngelesCalifornia90025-
Regeneron Research SiteLos AngelesCalifornia90033-
Regeneron Research SiteSacramentoCalifornia95815-
Regeneron Research SiteDavieFlorida33328-
Regeneron Research SiteSandy SpringsGeorgia30328-
Regeneron Research SiteRockvilleMaryland20850-
Regeneron Research SiteBay CityMichigan48706-
Regeneron Research SiteSaint JosephMichigan49085-
Regeneron Research SiteTroyMichigan48084-
Regeneron Research SiteForest HillsNew York11375-
Regeneron Research SiteNew YorkNew York10022-
Regeneron Research SiteNew YorkNew York10029-
Regeneron Research SiteThe BronxNew York10467-
Regeneron Research SiteHigh PointNorth Carolina27262-
Regeneron Research SiteNormanOklahoma73071-
Regeneron Research SitePortlandOregon97239-
Regeneron Research SitePittsburghPennsylvania15213-
Regeneron Research SiteArlingtonTexas76014-
Regeneron Research SiteRichmondVirginia23220-

Find similar trials in Phoenix, AZ

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Regeneron Research Site· Phoenix, AZRegeneron Research Site· Fountain Valley, CARegeneron Research Site· Long Beach, CARegeneron Research Site· Los Angeles, CARegeneron Research Site· Sacramento, CARegeneron Research Site· Davie, FL

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