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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT00455429 |
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Date of registration:
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01/04/2007 |
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Primary sponsor: |
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Public title:
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An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
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Scientific title:
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A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Exploratory Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis That is Moderate in Severity |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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84 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00455429 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:-Adult participants with Atopic Dermatitis (skin rash, inflammation)
involving greater than or equal to 10 percent body surface area
- Female participants must have a negative serum pregnancy test at screening
- 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
- Female participants of child bearing potential 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
clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic,
pulmonary, neurologic, respiratory (with the exception of well-controlled asthma),
endocrine or cardiovascular abnormalities or psychiatric disorders
- Participants with screening alanine aminotransferase, alkaline phosphatase or direct
bilirubin levels above the upper limit of normal
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Drug: JNJ-26113100 (100 mg) once daily
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Drug: JNJ-26113100 (100 mg) twice daily
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Drug: JNJ-26113100 (250 mg) twice daily
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Drug: JNJ-26113100 (50 mg) once daily
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Drug: Placebo
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Primary Outcome(s)
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Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
[Time Frame: Baseline and Week 6]
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Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
[Time Frame: Baseline and Week 6]
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Investigator's Global Assessment (IGA) Score at Week 6
[Time Frame: Week 6]
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Number of Flare Occurrences per Participant
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving Greater than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving Greater than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving Greater than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving Greater than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6
[Time Frame: Baseline up to Week 6]
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Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
[Time Frame: Baseline up to Week 6]
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Percentage of Participants who had at Least 1 Flare
[Time Frame: Baseline up to Week 6]
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Percentage of Participants who had at least 1 Worsening AD Event
[Time Frame: Baseline up to Week 6]
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Secondary Outcome(s)
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Plasma concentration of JNJ-26113100
[Time Frame: Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6]
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Secondary ID(s)
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C-2006-004
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CR012946
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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