A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02395133
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.
  • Placebo — DRUG
    Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).

Study Details

The primary objective of the study was to assess the ability of different Dupilumab dose regimens, administered as monotherapy, to maintain the treatment response achieved after 16 weeks of initial treatment with Dupilumab monotherapy compared to placebo.

Key Dates

Start date
Mar 25, 2015
Status verified
Feb 2020
Primary completion
Jul 31, 2016
Completion
Oct 18, 2016

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW) from Week 1 (Day 1) to Week 36.
  • Experimental: Dupilumab 300 mg Q8W
    Subcutaneous injection of Dupilumab 300 milligram (mg) alternatively with placebo (matched to Dupilumab) was administered once every eight week (Q8W) from Week 1 to Week 36.
  • Experimental: Dupilumab 300 mg Q4W
    Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every four week (Q4W) from Week 1 to Week 36.
  • Experimental: Dupilumab 300 mg Q2W/QW
    Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered once every week (QW) or twice a week (Q2W) from Week 1 to Week 36.

Primary Outcome Measure

Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769) [ Time Frame: Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study) ]

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