Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01639040
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Dupilumab 300 mg once weekly (QW) for 4 weeks
  • Placebo (for Dupilumab) — DRUG
    Placebo (for Dupilumab) once weekly (QW) for 4 weeks
  • Topical Corticosteroid (TCS) — OTHER
    TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

Study Details

The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Jul 31, 2012
Status verified
May 2017
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: Placebo QW
    Placebo (for Dupilumab) once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent topical corticosteroid (TCS) for up to 28 days
  • Experimental: Dupilumab 300 mg QW
    Dupilumab 300 mg once weekly (QW) for 4 weeks by subcutaneous injection with the background therapy of potent TCS for up to 28 days

Primary Outcome Measure

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to the end of study (up to Day 78) ]

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