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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
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: ASB17061
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Investigator's Global Assessment (IGA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 370
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose ASB17061
Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
Drug: ASB17061
Oral administration of ASB17061 taken once daily for 28 consecutive days.
Experimental: Middle dose ASB17061
Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
Drug: ASB17061
Oral administration of ASB17061 taken once daily for 28 consecutive days.
Experimental: High dose ASB17061
Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
Drug: ASB17061
Oral administration of ASB17061 taken once daily for 28 consecutive days.
Placebo Comparator: Placebo
Oral administration of placebo taken once daily for 28 consecutive days.
Drug: Placebo
Oral administration of placebo taken once daily for 28 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01756898

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix, Arizona, United States, 85018
Rogers, Arizona, United States, 72758
United States, California
Encino, California, United States, 91436
Fremont, California, United States, 94538
San Diego, California, United States, 92122
Temecula, California, United States, 92592
United States, Colorado
Denver, Colorado, United States, 80220
United States, Florida
Miami, Florida, United States, 33175
Miami, Florida, United States, 33144
Miramar, Florida, United States, 33027
Saint Augustine, Florida, United States, 32086
South Tampa, Florida, United States, 33609
Tampa, Florida, United States, 33609
Tampa, Florida, United States, 33613
United States, Georgia
Savannah, Georgia, United States, 31405
United States, Idaho
Boise, Idaho, United States, 83704
United States, Kansas
Overland Park, Kansas, United States, 66215
United States, Louisiana
Crowley, Louisiana, United States, 70526
United States, Michigan
Bay City, Michigan, United States, 48706
Clinton Township, Michigan, United States, 48038
Fort Gratiot, Michigan, United States, 48059
United States, New Jersey
Berlin, New Jersey, United States, 08009
Verona, New Jersey, United States, 07044
United States, New York
Stony Brook, New York, United States, 11790
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Sylvania, Ohio, United States, 43560
United States, Oregon
Oswego, Oregon, United States, 97035
Portland, Oregon, United States, 97239
United States, Rhode Island
Johnston, Rhode Island, United States, 02919
United States, Texas
Arlington, Texas, United States, 76011
College Station, Texas, United States, 77845
Pflugerville, Texas, United States, 78660
San Antonio, Texas, United States, 78229
Webster, Texas, United States, 77598
United States, Utah
Draper, Utah, United States, 84020
West Jordan, Utah, United States, 84088
United States, Virginia
Henrico, Virginia, United States, 23233
Norfolk, Virginia, United States, 23507
United States, Washington
Spokane, Washington, United States, 99204-4880
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
Investigators
Study Director: Ger Rikken, MD Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01756898     History of Changes
Other Study ID Numbers: ASBI 704
Study First Received: November 9, 2012
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Asubio Pharmaceuticals, Inc.:
Atopic Dermatitis
eczema

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 August 28, 2014