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

EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.

Time frame: Baseline and Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

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.

Time frame: Baseline and Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Participants were 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 (noinflammatory 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).

Time frame: Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.

A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of \>=50% from the baseline EASI score. An improvement of \<50% is considered a failure.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of \>=25% from the baseline EASI score. An improvement of \<25% is considered a failure.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Percentage of participants achieving treatment response (decrease) in IGA were 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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was 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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=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.

Time frame: Baseline up to Week 6

Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

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.

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

Population: Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to treatment groups and received at least 1 dose of study drug. LOCF method was used.