An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis

• Investigator's Global Assessment (IGA) Score at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  Participants will be reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).
  
  
• Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  EASI is used to assess the severity of AD. The 4 body regions of head and neck, trunk, upper limbs and lower limbs will be assessed separately. At each visit, the average clinical severity of each sign in each of the 4 body regions will be assigned a score of 0 (none) to 3 (severe), based on severity of disease. The area of skin involved in each body region will be determined and assigned a score of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption), based on extent of involvement.
  
  
• Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst possible itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours.
  
  
• Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  Percentage of participants achieving treatment response (decrease) in IGA will be assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema & perceptible papulation/infiltration), 2=mild (mild erythema & papulation/infiltration), 3=moderate (moderate erythema & papulation/infiltration), 4=severe (severe erythema & papulation/infiltration) & 5=very severe (severe erythema & papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to >=2.
  
  
• Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6 [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  EASI is used to assess the severity of AD. The 4 body regions of head and neck, trunk, upper limbs and lower limbs will be assessed separately. At each visit, the average clinical severity of each sign in each of the 4 body regions will be assigned a score of 0(none) to 3(severe), based on severity of disease. The area of skin involved in each body region will be determined and assigned a score of 0 (no eruption) to 6 (>90%-100% eruption), based on extent of involvement. Success is defined as an improvement of >=50% from the baseline EASI score. An improvement of <50% is considered a failure.
  
  
• Percentage of Participants Achieving Greater than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6 [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  EASI is used to assess the severity of AD. The 4 body regions of head and neck, trunk, upper limbs and lower limbs will be assessed separately. At each visit, the average clinical severity of each sign in each of the 4 body regions will be assigned a score of 0(none) to 3(severe), based on severity of disease. The area of skin involved in each body region will be determined and assigned a score of 0 (no eruption) to 6 (>90%-100% eruption), based on extent of involvement. Success is defined as an improvement of >=25% from the baseline EASI score. An improvement of <25% is considered a failure.
  
  
• 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 ] [ Designated as safety issue: No ]
  VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst Possible Itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=75% from the baseline VAS assessment of pruritus. An improvement of <75% is a failure.
  
  
• 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 ] [ Designated as safety issue: No ]
  VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst Possible Itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=50% from the baseline VAS assessment of pruritus. An improvement of <50% is a failure.
  
  
• 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 ] [ Designated as safety issue: No ]
  VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst Possible Itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of >=25% from the baseline VAS assessment of pruritus. An improvement of <25% is a failure.
  
  
• Percentage of Participants who had at Least 1 Flare [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  Percentage of participants who had at Least 1 Flare while on treatment will be assessed. A flare is considered to be present if the following criteria are met: 1) IGA is greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
  
  
• Number of Flare Occurrences per Participant [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  A flare is considered to be present if the following criteria are met: 1) IGA is greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
  
  
• Percentage of Participants who had at least 1 Worsening AD Event [ Time Frame: Baseline up to Week 6 ] [ Designated as safety issue: No ]
  Percentage of participants who had at least 1 worsening AD Event that did not meet flare criteria will be assessed. Worsening of AD that did not meet flare criteria will be documented. Flare is considered to be present if the following criteria are met: 1) IGA is greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
  
  

• 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 ] [ Designated as safety issue: No ]
  Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.
  
  

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.