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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01756898
First received: November 9, 2012
Last updated: June 3, 2014
Last verified: June 2014

November 9, 2012
June 3, 2014
December 2012
January 2014   (final data collection date for primary outcome measure)
Investigator's Global Assessment (IGA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01756898 on ClinicalTrials.gov Archive Site
  • Eczema Area and Severity Index Score (EASI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The Percentage of Body Surface Area (BSA) Involved [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Pruritus Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Insomnia Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Number of Patients with Abnormal Findings in Electrocardiograms, Serum Biomarkers, Clinical Laboratory Test, and Vital Signs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics: AUC and Cavg [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of Patients with Adverse Events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: ASB17061
    Oral administration of ASB17061 taken once daily for 28 consecutive days.
  • Drug: Placebo
    Oral administration of placebo taken once daily for 28 consecutive days.
  • Experimental: Low dose ASB17061
    Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
    Intervention: Drug: ASB17061
  • Experimental: Middle dose ASB17061
    Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
    Intervention: Drug: ASB17061
  • Experimental: High dose ASB17061
    Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
    Intervention: Drug: ASB17061
  • Placebo Comparator: Placebo
    Oral administration of placebo taken once daily for 28 consecutive days.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult subjects ages 18 to 65 years
  • A diagnosis of atopic dermatitis (AD)
  • An IGA score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
  • Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
  • Subjects must be practicing acceptable birth control methods

Exclusion Criteria:

  • Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
  • Use of phototherapy or tanning beds within 6 weeks of screening
  • Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
  • Female subjects who are pregnant or breastfeeding
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01756898
ASBI 704
No
Asubio Pharmaceuticals, Inc.
Asubio Pharmaceuticals, Inc.
Not Provided
Study Director: Ger Rikken, MD Asubio Pharmaceuticals, Inc.
Asubio Pharmaceuticals, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP