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| ID | Type | Description | Link |
|---|---|---|---|
| C-2006-004 |
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The study was stopped due to a non-clinical safety finding.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| JNJ-26113100 (50 mg) once daily | Experimental |
| |
| JNJ-26113100 (100 mg) once daily | Experimental |
| |
| JNJ-26113100 (100 mg) twice daily | Experimental |
| |
| JNJ-26113100 (250 mg) twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) Score at Week 6 | 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). | Week 6 |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6 | 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. | Baseline and Week 6 |
| Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6 | 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. | Baseline and Week 6 |
| Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-26113100 | 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. | 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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Inclusion Criteria:-Adult participants with Atopic Dermatitis (skin rash, inflammation) involving greater than or equal to 10 percent body surface area
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 for 6 weeks. |
| FG001 | JNJ-26113100 (50 mg) Once Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| JNJ-26113100 (50 mg) once daily | Drug | JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks. |
|
| JNJ-26113100 (100 mg) once daily | Drug | JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
|
| JNJ-26113100 (100 mg) twice daily | Drug | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
| JNJ-26113100 (250 mg) twice daily | Drug | JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks. |
|
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.
| Baseline up to Week 6 |
| Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6 | 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. | Baseline up to Week 6 |
| Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6 | 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. | Baseline up to Week 6 |
| Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6 | 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. | Baseline up to Week 6 |
| Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6 | 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. | Baseline up to Week 6 |
| Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6 | 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. | Baseline up to Week 6 |
| Percentage of Participants Who Had at Least 1 Flare | 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. | Baseline up to Week 6 |
| Number of Flare Occurrences Per Participant | 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. | Baseline up to Week 6 |
| Percentage of Participants Who Had at Least 1 Worsening AD Event | 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. | Baseline up to Week 6 |
| 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 |
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
| FG002 | JNJ-26113100 (100 mg) Once Daily | JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
| FG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 for 6 weeks. |
| BG001 | JNJ-26113100 (50 mg) Once Daily | JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks. |
| BG002 | JNJ-26113100 (100 mg) Once Daily | JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
| BG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator's Global Assessment (IGA) Score at Week 6 | 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). | 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. | Posted | Number | participants | Week 6 |
|
|
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| Primary | Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 6 |
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| Primary | Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and Week 6 |
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| Primary | Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6 | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Who Had at Least 1 Flare | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Primary | Number of Flare Occurrences Per Participant | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | participants | Baseline up to Week 6 |
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| Primary | Percentage of Participants Who Had at Least 1 Worsening AD Event | 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. | Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used. | Posted | Number | percentage of participants | Baseline up to Week 6 |
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| Secondary | Plasma Concentration of JNJ-26113100 | 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. | 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. | Posted | Mean | Standard Deviation | nanogram (ng)/milli litre (mL) | 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 |
|
From signing of informed consent until the study termination visit (Day 57)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 for 6 weeks. | 0 | 18 | 12 | 18 | ||
| EG001 | JNJ-26113100 (50 mg) Once Daily | JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks. | 0 | 15 | 10 | 15 | ||
| EG002 | JNJ-26113100 (100 mg) Once Daily | JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. | 0 | 17 | 14 | 17 | ||
| EG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. | 0 | 32 | 31 | 32 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Anal discomfort | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Foreign body trauma | Injury, poisoning and procedural complications | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA version 10.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA version 10.1 | Non-systematic Assessment |
|
Participants were not enrolled into JNJ-26113100(250 mg) twice daily dose because the study was stopped during 100mg twice daily dose due to preclinical finding of retinal atrophy in high dose group(150 mg/kg) of 6-month, albino rat toxicology study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Barchuk, M.D. | Janssen Research and Development, 3210 Merryfield Row San Diego, CA 92121 | 858-784-3111 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Almost Clear |
|
| Mild Disease |
|
| Moderate Disease |
|
| Severe Disease |
|
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | 0.656 | No | Superiority or Other |
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
| JNJ-26113100 (100 mg) Once Daily |
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
| OG002 |
| JNJ-26113100 (100 mg) Once Daily |
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks. |
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
| OG003 | JNJ-26113100 (100 mg) Twice Daily | JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
|
|
|
| JNJ-26113100 (100 mg) Twice Daily |
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|