A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.

Key facts

Study ID

NCT00717769

Run by

Daiichi Sankyo

People needed

270

Starts

2008-07-16

Expected to finish

2009-04-09

Last updated by the study team

2021-04-21

Who can join

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

You may qualify if…

• Male or female participants between 18 and 65 years of age.
• A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
• At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.

You may not qualify if…

• Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
• Use of phototherapy or tanning beds within 6 weeks of screening
• History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
• Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).

Where it is running

• Radiant Research, Inc. — Birmingham, Alabama, United States
• Pivotal Research Center — Mesa, Arizona, United States
• Pivotal Research Center — Peoria, Arizona, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Therapeutics Clinical Research — San Diego, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Miami Research Associates — Miami, Florida, United States
• Advanced Dermatology and Cosmetic Surgery — Ormond Beach, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• Deaconess Clinic Downtown Research Institute — Evansville, Indiana, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Michigan Center for Skin Care Research — Clinton Township, Michigan, United States
• Academic Dermatology — Albuquerque, New Mexico, United States
• Derm Research Center of New York, Inc. — Stony Brook, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Wake Forest University Health Sciences - Dermatology Studies — Winston-Salem, North Carolina, United States
• Toledo Center for Clinical Research — Sylvania, Ohio, United States
• Oklahoma University Health Sciences Center, Dermatology Dept — Oklahoma City, Oklahoma, United States
• Paddington Testing Co, Inc. — Philadelphia, Pennsylvania, United States
• Clinical Partners, LLC — Johnston, Rhode Island, United States
• Radiant Research, Inc — Greer, South Carolina, United States
• J & S Studies, Inc — College Station, Texas, United States
• Baylor Research Institute of Dermatology Department — Dallas, Texas, United States
• Dermatology Associates of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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