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

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT01756898

Run by

Daiichi Sankyo

People needed

370

Starts

2012-11-28

Expected to finish

2014-01-14

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Rogers, Arkansas, United States
• Study site — Encino, California, United States
• Study site — Fremont, California, United States
• Study site — San Diego, California, United States
• Study site — Temecula, California, United States
• Study site — Denver, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miramar, Florida, United States
• Study site — Saint Augustine, Florida, United States
• Study site — South Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Overland Park, Kansas, United States
• Study site — Crowley, Louisiana, United States
• Study site — Bay City, Michigan, United States
• Study site — Clinton Township, Michigan, United States
• Study site — Fort Gratiot, Michigan, United States
• Study site — Berlin, New Jersey, United States
• Study site — Verona, New Jersey, United States
• Study site — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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