Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01548404
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Subcutaneous injection altered between back of arms, abdomen and upper thighs.
  • Dupilumab — DRUG
    Subcutaneous injection altered between back of arms, abdomen and upper thighs.

Study Details

The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Apr 30, 2012
Status verified
Nov 2017
Primary completion
Mar 31, 2013
Completion
Jun 30, 2013

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection.
  • Experimental: Dupilumab 300 mg
    Dupilumab 300 mg once weekly for 12 weeks by SC injection.

Primary Outcome Measure

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) [ Time Frame: Baseline to Week 12 ]

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