A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
Inclusion Criteria:
Exclusion Criteria:
Participation in a prior Dupilumab clinical study.
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
Known or suspected history of immunosuppression;
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.