Status:
COMPLETED
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Lead Sponsor:
Daiichi Sankyo
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2009
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00717769
Start Date
July 16 2008
End Date
April 9 2009
Last Update
April 21 2021
Active Locations (28)
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1
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
2
Pivotal Research Center
Mesa, Arizona, United States, 85210
3
Pivotal Research Center
Peoria, Arizona, United States, 85381
4
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913