Trial Outcomes & Findings for An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis (NCT NCT00455429)
NCT ID: NCT00455429
Last Updated: 2014-03-12
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Week 6
Results posted on
2014-03-12
Participant Flow
Participant milestones
| Measure |
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.
|
JNJ-26113100 (50 mg) Once Daily
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
17
|
34
|
|
Overall Study
Treated
|
18
|
15
|
17
|
32
|
|
Overall Study
COMPLETED
|
16
|
10
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
1
|
14
|
Reasons for withdrawal
| Measure |
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.
|
JNJ-26113100 (50 mg) Once Daily
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
3
|
|
Overall Study
Randomly assigned but not treated
|
0
|
0
|
0
|
2
|
|
Overall Study
Personal Reason
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
2
|
0
|
1
|
Baseline Characteristics
An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=34 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 11.84 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 14.67 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 14.50 • n=4 Participants
|
36.0 years
STANDARD_DEVIATION 13.84 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Investigator's Global Assessment (IGA) Score at Week 6
Clear
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Investigator's Global Assessment (IGA) Score at Week 6
Almost Clear
|
3 participants
|
4 participants
|
2 participants
|
4 participants
|
|
Investigator's Global Assessment (IGA) Score at Week 6
Mild Disease
|
5 participants
|
3 participants
|
4 participants
|
5 participants
|
|
Investigator's Global Assessment (IGA) Score at Week 6
Moderate Disease
|
7 participants
|
6 participants
|
9 participants
|
19 participants
|
|
Investigator's Global Assessment (IGA) Score at Week 6
Severe Disease
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
Baseline
|
13.7 units on a scale
Standard Deviation 10.93
|
12.6 units on a scale
Standard Deviation 6.63
|
14.3 units on a scale
Standard Deviation 9.32
|
17.2 units on a scale
Standard Deviation 12.23
|
|
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
Change at Week 6
|
-2.3 units on a scale
Standard Deviation 5.97
|
-5.5 units on a scale
Standard Deviation 5.78
|
-3.7 units on a scale
Standard Deviation 7.18
|
-4.2 units on a scale
Standard Deviation 9.67
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
Baseline
|
49.4 millimeter (mm)
Standard Deviation 27.94
|
47.9 millimeter (mm)
Standard Deviation 27.78
|
65.3 millimeter (mm)
Standard Deviation 18.37
|
63.4 millimeter (mm)
Standard Deviation 23.02
|
|
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
Change at Week 6
|
-24.8 millimeter (mm)
Standard Deviation 32.44
|
-19.9 millimeter (mm)
Standard Deviation 31.16
|
-22.8 millimeter (mm)
Standard Deviation 26.66
|
-20.6 millimeter (mm)
Standard Deviation 29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
Success
|
27.8 percentage of participants
27.94
|
40.0 percentage of participants
27.78
|
17.6 percentage of participants
18.37
|
18.8 percentage of participants
23.02
|
|
Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
Failure
|
72.2 percentage of participants
32.44
|
60.0 percentage of participants
31.16
|
82.4 percentage of participants
26.66
|
81.3 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
Success
|
44.4 percentage of participants
27.94
|
60.0 percentage of participants
27.78
|
41.2 percentage of participants
18.37
|
31.3 percentage of participants
23.02
|
|
Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
Failure
|
55.6 percentage of participants
32.44
|
40.0 percentage of participants
31.16
|
58.8 percentage of participants
26.66
|
68.8 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
Success
|
55.6 percentage of participants
27.94
|
73.3 percentage of participants
27.78
|
64.7 percentage of participants
18.37
|
40.6 percentage of participants
23.02
|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
Failure
|
44.4 percentage of participants
32.44
|
26.7 percentage of participants
31.16
|
35.3 percentage of participants
26.66
|
59.4 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=31 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6
Success
|
27.8 percentage of participants
27.94
|
20.0 percentage of participants
27.78
|
23.5 percentage of participants
18.37
|
12.9 percentage of participants
23.02
|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6
Failure
|
72.2 percentage of participants
32.44
|
80.0 percentage of participants
31.16
|
76.5 percentage of participants
26.66
|
87.1 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=31 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6
Success
|
50.0 percentage of participants
27.94
|
60.0 percentage of participants
27.78
|
41.2 percentage of participants
18.37
|
38.7 percentage of participants
23.02
|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6
Faliure
|
50.0 percentage of participants
32.44
|
40.0 percentage of participants
31.16
|
58.8 percentage of participants
26.66
|
61.3 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=31 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6
Success
|
55.6 percentage of participants
27.94
|
73.3 percentage of participants
27.78
|
41.2 percentage of participants
18.37
|
58.1 percentage of participants
23.02
|
|
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6
Failure
|
44.4 percentage of participants
32.44
|
26.7 percentage of participants
31.16
|
58.8 percentage of participants
26.66
|
41.9 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 1 Flare
YES
|
50.0 percentage of participants
27.94
|
60.0 percentage of participants
27.78
|
35.3 percentage of participants
18.37
|
34.4 percentage of participants
23.02
|
|
Percentage of Participants Who Had at Least 1 Flare
NO
|
50.0 percentage of participants
32.44
|
40.0 percentage of participants
31.16
|
64.7 percentage of participants
26.66
|
65.6 percentage of participants
29.18
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Number of Flare Occurrences Per Participant
0 flare
|
9 participants
27.94
|
6 participants
27.78
|
11 participants
18.37
|
21 participants
23.02
|
|
Number of Flare Occurrences Per Participant
1 flare
|
6 participants
32.44
|
3 participants
31.16
|
4 participants
26.66
|
9 participants
29.18
|
|
Number of Flare Occurrences Per Participant
2 flares
|
3 participants
|
5 participants
|
2 participants
|
1 participants
|
|
Number of Flare Occurrences Per Participant
3 flares
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 6Population: 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.
Outcome measures
| Measure |
Placebo
n=18 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 Participants
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Had at Least 1 Worsening AD Event
YES
|
11.1 percentage of participants
27.94
|
20.0 percentage of participants
27.78
|
11.8 percentage of participants
18.37
|
21.9 percentage of participants
23.02
|
|
Percentage of Participants Who Had at Least 1 Worsening AD Event
NO
|
88.9 percentage of participants
32.44
|
80.0 percentage of participants
31.16
|
88.2 percentage of participants
26.66
|
78.1 percentage of participants
29.18
|
SECONDARY outcome
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 6Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=15 Participants
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.
|
JNJ-26113100 (50 mg) Once Daily
n=17 Participants
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=30 Participants
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Plasma Concentration of JNJ-26113100
Predose (Day 1)
|
NA nanogram (ng)/milli litre (mL)
Standard Deviation NA
For all participants the plasma concentration was below quantifiable limit (BQL \[1 ng/ml\]). Lower limit of quantification = 1.0 ng/mL.
|
NA nanogram (ng)/milli litre (mL)
Standard Deviation NA
For all participants the plasma concentration was below quantifiable limit (BQL \[1 ng/ml\]). Lower limit of quantification = 1.0 ng/mL.
|
1.07 nanogram (ng)/milli litre (mL)
Standard Deviation NA
Only one participant had plasma concentration above the below quantifiable limit (BQL \[1ng/ml\]). Lower limit of quantification = 1.0 ng/mL.
|
—
|
|
Plasma Concentration of JNJ-26113100
Postdose (0.25 - 3 h, Week 3)
|
195 nanogram (ng)/milli litre (mL)
Standard Deviation 402
|
1050 nanogram (ng)/milli litre (mL)
Standard Deviation 962
|
1542 nanogram (ng)/milli litre (mL)
Standard Deviation 1406
|
—
|
|
Plasma Concentration of JNJ-26113100
Predose (Week 6)
|
112 nanogram (ng)/milli litre (mL)
Standard Deviation 103
|
346 nanogram (ng)/milli litre (mL)
Standard Deviation 472
|
965 nanogram (ng)/milli litre (mL)
Standard Deviation 732
|
—
|
|
Plasma Concentration of JNJ-26113100
Postdose (0.25 - 3 h, Week 6)
|
285 nanogram (ng)/milli litre (mL)
Standard Deviation 261
|
1420 nanogram (ng)/milli litre (mL)
Standard Deviation 1734
|
1475 nanogram (ng)/milli litre (mL)
Standard Deviation 1486
|
—
|
|
Plasma Concentration of JNJ-26113100
Postdose (4 - 6 h, Week 6)
|
630 nanogram (ng)/milli litre (mL)
Standard Deviation 318
|
1889 nanogram (ng)/milli litre (mL)
Standard Deviation 976
|
1728 nanogram (ng)/milli litre (mL)
Standard Deviation 867
|
—
|
|
Plasma Concentration of JNJ-26113100
Postdose (0.25 - 3 h, Day 1)
|
228 nanogram (ng)/milli litre (mL)
Standard Deviation 249
|
979 nanogram (ng)/milli litre (mL)
Standard Deviation 1089
|
787 nanogram (ng)/milli litre (mL)
Standard Deviation 1262
|
—
|
|
Plasma Concentration of JNJ-26113100
Predose (Week 3)
|
43.0 nanogram (ng)/milli litre (mL)
Standard Deviation 28.2
|
324 nanogram (ng)/milli litre (mL)
Standard Deviation 328
|
665 nanogram (ng)/milli litre (mL)
Standard Deviation 683
|
—
|
|
Plasma Concentration of JNJ-26113100
Postdose (7 -12 h, Week 6)
|
417 nanogram (ng)/milli litre (mL)
Standard Deviation 196
|
1182 nanogram (ng)/milli litre (mL)
Standard Deviation 676
|
1305 nanogram (ng)/milli litre (mL)
Standard Deviation 703
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
JNJ-26113100 (50 mg) Once Daily
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
JNJ-26113100 (100 mg) Once Daily
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
JNJ-26113100 (100 mg) Twice Daily
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=18 participants at risk
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.
|
JNJ-26113100 (50 mg) Once Daily
n=15 participants at risk
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Once Daily
n=17 participants at risk
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
|
JNJ-26113100 (100 mg) Twice Daily
n=32 participants at risk
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
15.6%
5/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
17.6%
3/17 • From signing of informed consent until the study termination visit (Day 57)
|
12.5%
4/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
13.3%
2/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Wound infection
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Abscess
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Ear infection
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Gastroenteritis
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
16.7%
3/18 • From signing of informed consent until the study termination visit (Day 57)
|
20.0%
3/15 • From signing of informed consent until the study termination visit (Day 57)
|
17.6%
3/17 • From signing of informed consent until the study termination visit (Day 57)
|
21.9%
7/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
6.2%
2/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
20.0%
3/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
6.2%
2/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
17.6%
3/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
13.3%
2/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Anal discomfort
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
2/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
9.4%
3/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Investigations
Urine albumin/creatinine ratio increased
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
12.5%
4/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
6.2%
2/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
9.4%
3/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Eye disorders
Conjunctivitis
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
General disorders
Malaise
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
General disorders
Edema peripheral
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
General disorders
Pain
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
6.2%
2/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.1%
2/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
11.8%
2/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
6.7%
1/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
3.1%
1/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
5.9%
1/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/15 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/17 • From signing of informed consent until the study termination visit (Day 57)
|
0.00%
0/32 • From signing of informed consent until the study termination visit (Day 57)
|
Additional Information
William Barchuk, M.D.
Janssen Research and Development, 3210 Merryfield Row San Diego, CA 92121
Phone: 858-784-3111
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60