A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participation in a prior Dupilumab clinical trial;
Important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician;
Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment:
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 hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at the screening visit;
Active or acute infection requiring systemic treatment within 2 weeks before baseline visit;
Known or suspected history of immunosuppression;
Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study.
Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
Dulwich, Queensland, Australia
Kamimashiki-gun, Kumamoto, Japan
Saitama-shi, Saitama, Japan
Koto-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Adachi-ku, Tôkyô, Japan
Chiyoda-ku, Tôkyô, Japan
Nerima-ku, Tôkyô, Japan
Shibuya-ku, Tôkyô, Japan
Shinagawa-ku, Tôkyô, Japan
Shinjuku-ku, Tôkyô, Japan
Suginami-ku, Tôkyô, Japan
Seodaemun-gu, South Korea