Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01385657
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    A total of 4 doses were administered.
  • Dupilumab — DRUG
    A total of 4 doses were administered.
  • Background treatment — OTHER
    Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.

Study Details

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).

Key Dates

Start date
Jul 31, 2011
Status verified
Feb 2020
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Placebo
    Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22
  • Experimental: Dupilumab 150 mg
    Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22
  • Experimental: Dupilumab 300 mg
    Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22

Primary Outcome Measure

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to end of study (up to Day 85) ]

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