Clinical trial NCT00455429: An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
JNJ-26113100
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-04-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of four dose regimens (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis (\[AD\]; skin rash, inflammation) that is moderate in severity.

Detailed description: This study is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), sequential cohort exploratory study to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult AD that is moderate in severity, including its effect on inflammatory biomarkers (biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease). Participants will be sequentially assigned to 50 milligram (mg) once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily cohort and randomly assigned to receive JNJ-26113100 or matching placebo.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Score at Week 6
timeFrame: Week 6
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
timeFrame: Baseline and Week 6
measure: Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Who Had at Least 1 Flare
timeFrame: Baseline up to Week 6
measure: Number of Flare Occurrences Per Participant
timeFrame: Baseline up to Week 6
measure: Percentage of Participants Who Had at Least 1 Worsening AD Event
timeFrame: Baseline up to Week 6
Secondary outcomes:
measure: Plasma Concentration of JNJ-26113100
timeFrame: 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
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Vista
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Sylvania
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: College Station
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial
role: STUDY_DIRECTOR
References: