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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: July 16, 2008
Last updated: October 19, 2015
Last verified: October 2015
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult subjects with atopic dermatitis

Condition Intervention Phase
Atopic Dermatitis
Drug: SUN13834
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Eczema Area and Severity Index (EASI) Score measured throughout the study [ Time Frame: throughout study ]

Secondary Outcome Measures:
  • Investigator's Global Assessment measured throughout the study [ Time Frame: throughout study ]
  • Pruritis score measured throughout the study [ Time Frame: throughout study ]
  • Insomnia evaluation measured throughout the study [ Time Frame: throughout study ]
  • Safety and tolerability data as measured by adverse events, electrocardiograms, serum biomarkers, clinical laboratory tests, and vital signs [ Time Frame: throughout study ]

Enrollment: 270
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SUN13834
Daily oral doses, low dose, for 28 days of SUN13834
Placebo Comparator: 2 Drug: Placebo
Daily oral doses, placebo, for 28 days of SUN13834


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects between 18 and 65 years of age (inclusive).
  • A diagnosis of AD, meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria

Exclusion Criteria:

  • 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 interpretation of data from this patient (eg, renal impairment with non-atopic pruritis).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00717769

  Show 28 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc. Identifier: NCT00717769     History of Changes
Other Study ID Numbers: ASBI 404
Study First Received: July 16, 2008
Last Updated: October 19, 2015

Keywords provided by Daiichi Sankyo Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases processed this record on April 28, 2017