Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
NCT ID: NCT01756898
Last Updated: 2021-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
370 participants
INTERVENTIONAL
2012-11-28
2014-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose ASB17061
Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
5 mg ASB17061
Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.
Middle dose ASB17061
Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
10 mg ASB17061
Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.
High dose ASB17061
Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
20 mg ASB17061
Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Placebo
Oral administration of placebo taken once daily for 28 consecutive days.
Placebo
Oral administration of placebo taken once daily for 28 consecutive days.
Interventions
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5 mg ASB17061
Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.
Placebo
Oral administration of placebo taken once daily for 28 consecutive days.
10 mg ASB17061
Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.
20 mg ASB17061
Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Rogers, Arkansas, United States
Encino, California, United States
Fremont, California, United States
San Diego, California, United States
Temecula, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Saint Augustine, Florida, United States
South Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Overland Park, Kansas, United States
Crowley, Louisiana, United States
Bay City, Michigan, United States
Clinton Township, Michigan, United States
Fort Gratiot, Michigan, United States
Berlin, New Jersey, United States
Verona, New Jersey, United States
Stony Brook, New York, United States
Raleigh, North Carolina, United States
Sylvania, Ohio, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Johnston, Rhode Island, United States
Arlington, Texas, United States
College Station, Texas, United States
Pflugerville, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Draper, Utah, United States
West Jordan, Utah, United States
Henrico, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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ASBI 704
Identifier Type: -
Identifier Source: org_study_id
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