Study of Dupilumab (REGN668/SAR231893) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2013
End Date:September 2014

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

To assess the efficacy of multiple dupilumab (REGN668/SAR231893) dose-regimens, compared to
placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).


The inclusion criteria include, but are not limited to, the following:

1. Chronic Atopic Dermatitis that has been present for at least 3 years

2. History of inadequate response to outpatient treatment with topical medications, or
for whom topical treatments are otherwise inadvisable (eg, because of important side
effects or safety risks)

3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria include, but are not limited to, the following:

1. Prior treatment with dupilumab (REGN668/ SAR231893)

2. Presence of certain laboratory abnormalities at the screening visit

3. Treatment with an investigational drug within 8 weeks of baseline visit

4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

5. Certain other treatments and medical procedures undertaken within a particular
timeframe prior to the baseline visit

6. Known history of human immunodeficiency virus (HIV) infection

7. History of malignancy within 5 years before the baseline visit (with certain
exceptions)

8. Planned surgical procedure during the length of the study

9. High risk of parasite infection

10. Any other medical or psychological condition that, in the opinion of the investigator
or the sponsor's medical monitor, would place the patient at risk, interfere with
participation in the study or interfere with interpretation of study results.

11. Pregnant or breast-feeding women
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