An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
NCT ID: NCT00455429
Last Updated: 2014-03-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
84 participants
INTERVENTIONAL
2007-04-30
2009-03-31
Brief Summary
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Detailed Description
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The total duration of the study will be approximately 8 weeks. Participants will be asked to follow-up at the end of Week 1, 2, 3, 4, 5 and 6. A study termination visit (Day 57) will be conducted at the end of Week 8. Skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Participants developing flares of their disease may be treated with triamcinolone acetonide 0.1 percent ointment twice daily for up to 7 days. Efficacy will be assessed using Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Matching placebo capsules to JNJ-26113100 (50 milligram \[mg\]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.
JNJ-26113100 (50 mg) once daily
JNJ-26113100 (50 mg) once daily
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
JNJ-26113100 (250 mg) twice daily
JNJ-26113100 (250 mg) twice daily
JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
Interventions
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Placebo
Matching placebo capsules to JNJ-26113100 (50 milligram \[mg\]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.
JNJ-26113100 (50 mg) once daily
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
JNJ-26113100 (250 mg) twice daily
JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* With the exception of well-controlled asthma, allergic rhinitis and food allergies, participants must be in good general health prior to study participation with no clinically significant abnormalities as assessed by the investigator and determined by medical history, physical examination, blood chemistry, complete blood count, coagulation tests, urinalysis and electrocardiogram (ECG)
* Male subjects must consent to utilize a medically acceptable method of contraception throughout the study including the washout period and for three months after the study is completed
Exclusion Criteria
* Evidence of any skin condition that in the opinion of the investigator would interfere with assessment of atopic dermatitis
* Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
* Use of any biologic within a period of 5 times its half-life
18 Years
65 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Huntsville, Alabama, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Stanford, California, United States
Vista, California, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Stony Brook, New York, United States
Sylvania, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
College Station, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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C-2006-004
Identifier Type: -
Identifier Source: secondary_id
CR012946
Identifier Type: -
Identifier Source: org_study_id
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