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

• Status: Completed
• Trial end date: 2014-01-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.

Criteria

Inclusion Criteria:

• Adult subjects ages 18 to 65 years

• A diagnosis of atopic dermatitis (AD)

• An Investigator's Global Assessment (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