Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01979016
Phase
PHASE2
Status
Completed

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
  • Placebo — DRUG
    Matching placebo
  • Background treatment — OTHER
    Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).

Study Details

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Dec 31, 2013
Status verified
Mar 2020
Primary completion
Dec 31, 2014
Completion
Jan 31, 2015

Study Design

Enrollment
54 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 once weekly (qw) from Week 1 to Week 15.
  • Experimental: Dupilumab 200 mg qw
    Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.

Primary Outcome Measure

Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16 [ Time Frame: Baseline to Week 16 ]

Locations (3)

FacilityCityStateZIPSite coordinators
-ChicagoIllinois--
-New YorkNew York--
-DallasTexas--

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