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

This study has been completed.

Sponsor:

Information provided by:

Asubio Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00717769

First received: July 16, 2008

Last updated: April 4, 2011

Last verified: April 2011

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 ]

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

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:	Ron Corey, PhD, MBA / Executive Director Clinical and Project Management, Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00717769 History of Changes
Other Study ID Numbers:	ASBI 404
Study First Received:	July 16, 2008
Last Updated:	April 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:

Atopic Dermatitis

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn

Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013