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

This study is ongoing, but not recruiting participants.

First Received: July 16, 2008 Last Updated: March 13, 2009 History of Changes

Sponsored by:	Asubio Pharmaceuticals, Inc.
Information provided by:	Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00717769

Purpose

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:

Eczema Area and Severity Index (EASI) Score measured throughout the study [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator's Global Assessment measured throughout the study [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Pruritis score measured throughout the study [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Insomnia evaluation measured throughout the study [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Safety and tolerability data as measured by adverse events, electrocardiograms, serum biomarkers, clinical laboratory tests, and vital signs [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	July 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SUN13834 Daily oral doses, low dose, for 28 days of SUN13834
2: Placebo Comparator	Drug: Placebo Daily oral doses, placebo, for 28 days of SUN13834

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717769

Sponsors and Collaborators

Asubio Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Asubio Pharmaceuticals, Inc. ( Ron Corey, PhD, MBA / Executive Director Clinical and Project Management )
Study ID Numbers:	ASBI 404
Study First Received:	July 16, 2008
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00717769 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:

Atopic Dermatitis

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009