A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:December 2012
End Date:January 2014

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A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

The purpose of this research study is to gather scientific information about the
effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult
subjects with atopic dermatitis.


Inclusion Criteria:

- Adult subjects ages 18 to 65 years

- A diagnosis of atopic dermatitis (AD)

- An IGA score of 2 or higher and AD affecting at least 5% of total Body Surface Area
(BSA)

- Other than active AD, in good health with no medical condition that may jeopardize
the safety of the subject or impact the validity of the study results

- Subjects must be practicing acceptable birth control methods

Exclusion Criteria:

- Taking systemic immunosuppressive therapy within 3 months prior to screening or
systemic (cortico) steroid therapy within 4 weeks prior to screening

- Use of phototherapy or tanning beds within 6 weeks of screening

- Presence of a clinically significant disorder involving gastrointestinal, renal,
hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic,
psychiatric, or cardiovascular disease or any other condition, which will jeopardize
the safety of the subject or impact the validity of the study results

- Female subjects who are pregnant or breastfeeding
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