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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 28 Study Locations
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 July 22, 2014