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A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945086
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: Ustekinumab
Drug: Placebo
Other: Concomitant topical medications for atopic dermatitis
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Period Title: Overall Study
Started 27 24 28
Completed 26 24 26
Not Completed 1 0 2
Reason Not Completed
Withdrawal by Subject             1             0             1
Adverse Event             0             0             1
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg Total
Hide Arm/Group Description Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4. Total of all reporting groups
Overall Number of Baseline Participants 27 24 28 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 24 participants 28 participants 79 participants
32.6  (10.05) 37.5  (8.77) 33.0  (8.85) 34.2  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 28 participants 79 participants
Female
8
  29.6%
7
  29.2%
9
  32.1%
24
  30.4%
Male
19
  70.4%
17
  70.8%
19
  67.9%
55
  69.6%
1.Primary Outcome
Title Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12
Hide Description The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and 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 percent [%]-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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: percent change
-37.54  (37.592) -38.62  (32.684) -39.39  (38.710)
2.Secondary Outcome
Title Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12
Hide Description The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
0 0 0
3.Secondary Outcome
Title Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Hide Description The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. LOCF method was used to impute the missing data. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (MDS [n=27, 24, 28]) 8.97  (3.784) 10.03  (4.615) 8.71  (3.752)
Change at Week 12 (MDS [n=27, 24, 28]) -1.58  (3.030) -1.68  (3.286) -2.59  (3.716)
Baseline (EDS [n=27, 23, 28]) 10.43  (3.569) 11.22  (4.371) 9.45  (3.697)
Change at Week 12 (EDS [n=27, 23, 28]) -2.07  (2.624) -1.91  (3.253) -2.14  (4.517)
4.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Hide Description The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.3  (3.74) 6.4  (4.58) 6.6  (3.74)
Change at Week 12 -0.6  (3.96) -1.7  (3.48) -1.7  (4.56)
5.Secondary Outcome
Title Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Hide Description The EASI score was used to measure the severity and extent of AD and 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 Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
Week 2:>=50% Decrease (n=27,24,28) 3 2 7
Week 2:>=75% Decrease (n=27,24,28) 1 0 0
Week 4:>=50% Decrease (n=27,24,27) 7 2 9
Week 4:>=75% Decrease (n=27,24,27) 2 0 2
Week 8:>=50% Decrease (n=27,24,27) 10 5 10
Week 8:>=75% Decrease (n=27,24,27) 5 1 3
Week 12:>=50% Decrease (n=27,24,27) 11 9 10
Week 12:>=75% Decrease (n=27,24,27) 4 2 5
Week 16:>=50% Decrease (n=26,24,27) 11 10 12
Week 16:>=75% Decrease (n=26,24,27) 5 4 3
Week 20:>=50% Decrease (n=26,24,26) 12 8 12
Week 20:>=75% Decrease (n=26,24,26) 6 3 5
Week 24:>=50% Decrease (n=26,24,27) 8 8 12
Week 24:>=75% Decrease (n=26,24,27) 4 4 5
6.Secondary Outcome
Title Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Hide Description The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Time Frame Baseline, Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
Baseline (n=27, 24, 28) 0 0 0
Week 2 (n=27, 24, 28) 0 0 0
Week 4 (n=27, 24, 27) 0 0 0
Week 8 (n=27, 24, 27) 0 0 1
Week 12 (n=27, 24, 27) 0 0 0
Week 16 (n=26, 24, 27) 2 0 1
Week 20 (n=26, 24, 26) 2 0 1
Week 24 (n=26, 24, 27) 1 0 1
7.Secondary Outcome
Title Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Hide Description The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Time Frame Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
Week 2 (n=27, 24, 28) 2 1 4
Week 4 (n=27, 24, 27) 5 2 3
Week 8 (n=27, 24, 27) 7 3 7
Week 12 (n=27, 24, 27) 7 7 7
Week 16 (n=26, 24, 27) 6 5 7
Week 20 (n=26, 24, 26) 6 6 7
Week 24 (n=26, 24, 27) 3 4 6
8.Secondary Outcome
Title Number of Participants in IGA
Hide Description The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
Time Frame Baseline, Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
Baseline: Clear (n=27,24,28) 0 0 0
Baseline: Almost clear (n=27,24,28) 0 0 0
Baseline: Mild disease (n=27,24,28) 0 0 0
Baseline: Moderate disease (n=27,24,28) 0 0 0
Baseline: Severe disease (n=27,24,28) 22 21 24
Baseline: Very severe disease (n=27,24,28) 5 3 4
Week 2: Clear (n=27,24,28) 0 0 0
Week 2: Almost clear (n=27,24,28) 0 0 0
Week 2: Mild disease (n=27,24,28) 1 0 4
Week 2: Moderate disease (n=27,24,28) 8 5 7
Week 2: Severe disease (n=27,24,28) 16 16 16
Week 2: Very severe disease (n=27,24,28) 2 3 1
Week 4: Clear (n=27,24,27) 0 0 0
Week 4: Almost clear (n=27,24,27) 0 0 0
Week 4: Mild disease (n=27,24,27) 2 0 2
Week 4: Moderate disease (n=27,24,27) 11 8 11
Week 4: Severe disease (n=27,24,27) 13 15 12
Week 4: Very severe disease (n=27,24,27) 1 1 2
Week 8: Clear (n=27,24,27) 0 0 0
Week 8: Almost clear (n=27,24,27) 0 0 1
Week 8: Mild disease (n=27,24,27) 6 1 4
Week 8: Moderate disease (n=27,24,27) 10 12 11
Week 8: Severe disease (n=27,24,27) 10 10 8
Week 8: Very severe disease (n=27,24,27) 1 1 3
Week 12: Clear (n=27,24,27) 0 0 0
Week 12: Almost clear (n=27,24,27) 0 0 0
Week 12: Mild disease (n=27,24,27) 6 5 6
Week 12: Moderate disease (n=27,24,27) 10 8 11
Week 12: Severe disease (n=27,24,27) 10 9 7
Week 12: Very severe disease (n=27,24,27) 1 2 3
Week 16: Clear (n=26,24,27) 0 0 0
Week 16: Almost clear (n=26,24,27) 2 0 1
Week 16: Mild disease (n=26,24,27) 3 3 5
Week 16: Moderate disease (n=26,24,27) 9 9 12
Week 16: Severe disease (n=26,24,27) 11 10 6
Week 16: Very severe disease (n=26,24,27) 1 2 3
Week 20: Clear (n=26,24,26) 0 0 0
Week 20: Almost clear (n=26,24,26) 2 0 1
Week 20: Mild disease (n=26,24,26) 3 3 5
Week 20: Moderate disease (n=26,24,26) 9 9 12
Week 20: Severe disease (n=26,24,26) 11 10 6
Week 20: Very severe disease (n=26,24,26) 2 2 2
Week 24: Clear (n=26,24,27) 0 0 0
Week 24: Almost clear (n=26,24,27) 2 0 1
Week 24: Mild disease (n=26,24,27) 1 4 6
Week 24: Moderate disease (n=26,24,27) 9 7 10
Week 24: Severe disease (n=26,24,27) 12 10 8
Week 24: Very severe disease (n=26,24,27) 2 3 2
9.Secondary Outcome
Title Percent Change From Baseline in EASI Total Score
Hide Description The EASI score was used to measure the severity and extent of AD and 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 Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: percent change
Week 2 (n=27,24,28) -24.29  (25.402) -13.85  (21.391) -25.72  (24.728)
Week 4 (n=27,24,27) -31.69  (28.936) -21.13  (24.097) -29.19  (30.409)
Week 8 (n=27,24,27) -36.06  (35.840) -31.15  (28.012) -34.49  (38.857)
Week 12 (n=27,24,27) -37.54  (37.592) -38.62  (32.684) -40.84  (38.655)
Week 16 (n=26,24,27) -39.97  (40.572) -38.43  (34.202) -44.39  (40.154)
Week 20 (n=26,24,26) -41.03  (43.495) -40.59  (31.666) -46.24  (41.817)
Week 24 (n=26,24,27) -35.93  (40.524) -38.83  (35.697) -46.19  (41.791)
10.Secondary Outcome
Title Percent Change From Baseline in EASI Sign of Disease Components
Hide Description The EASI score was used to measure the severity and extent of AD and 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 Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: percent change
Week 2: Erythema (n=27,24,28) -19.51  (21.533) -12.03  (13.049) -19.13  (19.091)
Week 4: Erythema (n=27,24,27) -23.24  (25.710) -17.17  (15.346) -21.51  (16.334)
Week 8: Erythema (n=27,24,27) -29.19  (27.937) -24.13  (18.549) -25.38  (21.390)
Week 12: Erythema (n=27,24,27) -30.06  (29.751) -29.73  (25.421) -29.89  (21.895)
Week 16: Erythema (n=26,24,27) -32.36  (32.911) -28.36  (30.209) -34.57  (21.759)
Week 20: Erythema (n=26,24,26) -31.81  (31.413) -32.43  (26.550) -34.84  (23.922)
Week 24: Erythema (n=26,24,27) -28.37  (30.243) -28.65  (27.249) -37.25  (23.711)
Week 2: Induration (n=27,24,28) -11.99  (34.591) -12.32  (14.315) -22.17  (24.515)
Week 4: Induration (n=27,24,27) -15.82  (39.898) -16.58  (17.491) -24.96  (26.132)
Week 8: Induration (n=27,24,27) -19.80  (43.965) -24.16  (22.658) -26.98  (29.825)
Week 12: Induration (n=27,24,27) -21.23  (49.075) -26.78  (29.282) -35.42  (29.943)
Week 16: Induration (n=26,24,27) -24.34  (51.739) -25.82  (32.690) -38.98  (26.767)
Week 20: Induration (n=26,24,26) -27.89  (53.568) -27.21  (29.162) -40.58  (31.136)
Week 24: Induration (n=26,24,27) -22.45  (50.002) -26.71  (31.240) -40.06  (30.864)
Week 2: Excoriation (n=27,23,28) -20.65  (21.825) -11.82  (19.872) -23.91  (25.419)
Week 4: Excoriation (n=27,23,27) -26.38  (28.258) -18.40  (19.323) -29.73  (28.764)
Week 8: Excoriation (n=27,23,27) -30.56  (35.800) -25.58  (27.607) -35.02  (30.400)
Week 12: Excoriation (n=27,23,27) -31.29  (37.259) -30.66  (36.517) -38.33  (27.953)
Week 16: Excoriation (n=26,23,27) -33.11  (40.899) -25.50  (41.929) -44.25  (27.690)
Week 20: Excoriation (n=26,23,26) -33.23  (42.648) -23.55  (36.947) -40.67  (33.036)
Week 24: Excoriation (n=26,23,27) -26.40  (37.853) -22.74  (37.555) -42.07  (33.992)
Week 2: Lichenification (n=267,24,28) -14.90  (20.292) -8.46  (16.879) -15.87  (18.500)
Week 4: Lichenification(n=27,24,27) -23.38  (25.947) -10.21  (23.359) -20.24  (24.284)
Week 8: Lichenification (n=27,24,27) -26.52  (28.515) -19.40  (22.871) -28.07  (27.887)
Week 12: Lichenification (n=27,24,27) -28.62  (31.241) -24.36  (29.272) -33.06  (25.443)
Week 16: Lichenification (n=26,24,27) -32.64  (34.378) -22.18  (34.489) -37.47  (27.046)
Week 20: Lichenification (n=26,24,26) -33.24  (35.094) -23.36  (43.750) -41.71  (30.241)
Week 24: Lichenification (n=26,24,27) -32.05  (33.470) -20.96  (45.278) -40.19  (26.696)
11.Secondary Outcome
Title Percent Change From Baseline of Body Region Scores in EASI
Hide Description The EASI score was used to measure the severity and extent of AD and 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 Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Mean (Standard Deviation)
Unit of Measure: percent change
Week 2: Head/neck (n=27,24,28) -20.28  (22.410) -6.97  (24.488) -29.50  (9.492)
Week 4: Head/neck (n=27,24,27) -26.22  (36.637) -17.46  (25.632) -34.15  (32.087)
Week 8: Head/neck (n=27,24,27) -29.34  (64.066) -34.27  (27.380) -38.65  (28.580)
Week 12: Head/neck (n=27,24,27) -32.82  (52.925) -36.28  (39.256) -45.34  (25.282)
Week 16: Head/neck (n=26,24,27) -37.27  (58.582) -38.31  (37.155) -52.12  (23.578)
Week 20: Head/neck (n=26,24,26) -35.20  (59.298) -42.63  (38.094) -46.30  (35.652)
Week 24: Head/neck (n=26,24,27) -24.84  (89.446) -37.20  (39.828) -49.63  (28.510)
Week 2: Upper limbs (n=27,24,28) -26.64  (29.149) -14.47  (22.285) -28.53  (26.760)
Week 4: Upper limbs (n=27,24,27) -33.25  (38.613) -21.62  (23.746) -30.26  (29.646)
Week 8: Upper limbs (n=27,24,27) -44.58  (38.100) -32.57  (28.600) -38.11  (37.205)
Week 12: Upper limbs (n=27,24,27) -40.64  (42.146) -36.55  (35.946) -47.01  (39.135)
Week 16: Upper limbs (n=26,24,27) -42.01  (45.743) -32.55  (47.614) -42.94  (42.543)
Week 20: Upper limbs (n=26,24,26) -41.48  (46.700) -37.71  (36.660) -48.20  (37.501)
Week 24: Upper limbs (n=26,24,27) -39.61  (45.005) -39.36  (36.535) -50.89  (39.446)
Week 2: Trunk (n=27,24,28) -27.82  (27.633) -18.16  (22.783) -21.84  (33.368)
Week 4: Trunk (n=27,24,27) -34.42  (34.730) -20.59  (26.028) -23.51  (46.987)
Week 8: Trunk (n=27,24,27) -32.28  (49.544) -27.99  (29.551) -29.26  (54.157)
Week 12: Trunk (n=27,24,27) -33.38  (57.021) -36.89  (35.351) -31.65  (54.961)
Week 16: Trunk (n=26,24,27) -35.33  (59.694) -28.96  (41.260) -37.87  (54.763)
Week 20: Trunk (n=26,24,26) -36.37  (62.253) -32.68  (36.306) -41.92  (58.260)
Week 24: Trunk (n=26,24,27) -28.39  (59.596) -31.25  (40.207) -39.77  (56.008)
Week 2: Lower limbs (n=27,24,28) -19.84  (29.862) -9.17  (32.015) -26.15  (26.073)
Week 4: Lower limbs (n=27,24,27) -26.46  (33.485) -21.32  (33.541) -33.12  (37.005)
Week 8: Lower limbs (n=27,24,27) -31.23  (46.154) -31.88  (36.302) -27.56  (82.889)
Week 12: Lower limbs (n=27,24,27) -34.79  (45.961) -42.01  (35.358) -32.39  (83.114)
Week 16: Lower limbs (n=26,24,27) -36.98  (48.713) -46.30  (34.942) -36.87  (84.182)
Week 20: Lower limbs (n=26,24,26) -38.06  (53.187) -45.50  (34.350) -38.92  (86.354)
Week 24: Lower limbs (n=26,24,27) -33.60  (50.984) -41.55  (40.522) -39.80  (87.186)
12.Secondary Outcome
Title Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Hide Description The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 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, Week 2, 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
Overall Number of Participants Analyzed 27 24 28
Measure Type: Number
Unit of Measure: participants
Baseline: Erythema (n=27,24,28) 0 0 0
Week 2: Erythema (n=27,24,28) 1 0 1
Week 4: Erythema (n=27,24,27) 4 0 1
Week 8: Erythema (n=27,24,27) 4 1 2
Week 12: Erythema (n=27,24,27) 5 5 3
Week 16: Erythema (n=26,24,27) 4 4 7
Week 20: Erythema (n=26,24,26) 4 4 5
Week 24: Erythema (n=26,24,27) 5 3 6
Baseline: Induration (n=27,24,28) 1 0 0
Week 2: Induration (n=27,24,28) 1 0 2
Week 4: Induration (n=27,24,27) 5 0 3
Week 8: Induration (n=27,24,27) 4 1 3
Week 12: Induration (n=27,24,27) 3 6 7
Week 16: Induration (n=26,24,27) 6 5 8
Week 20: Induration (n=26,24,26) 7 3 7
Week 24: Induration (n=26,24,27) 5 3 8
Baseline: Excoriation (n=27,24,28) 0 1 1
Week 2: Excoriation (27,24,28) 2 2 4
Week 4: Excoriation (n=27,24,27) 5 2 7
Week 8: Excoriation (n=27,24,27) 5 3 7
Week 12: Excoriation (n=27,24,27) 4 9 6
Week 16: Excoriation (n=26,24,27) 7 7 9
Week 20: Excoriation (n=26,24,26) 7 4 7
Week 24: Excoriation (n=26,24,27) 4 5 8
Baseline: Lichenification (n=27,24,28) 0 1 0
Week 2: Lichenification (n=27,24,28) 1 1 2
Week 4: Lichenification (n=27,24,27) 4 0 3
Week 8: Lichenification (n=27,24,27) 4 2 2
Week 12: Lichenification (n=27,24,27) 4 6 5
Week 16: Lichenification (n=26,24,27) 6 4 8
Week 20: Lichenification (n=26,24,26) 6 4 7
Week 24: Lichenification (n=26,24,27) 5 5 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4. Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
All-Cause Mortality
Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/24 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/27 (74.07%)   18/24 (75.00%)   16/28 (57.14%) 
Blood and lymphatic system disorders       
Lymphadenitis * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Eye disorders       
Blepharitis * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Conjunctivitis allergic * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  1/27 (3.70%)  1/24 (4.17%)  0/28 (0.00%) 
Periodontal disease * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Diarrhoea * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
General disorders       
Malaise * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Hepatobiliary disorders       
Fatty liver alcoholic * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Hepatitis alcoholic * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  7/27 (25.93%)  6/24 (25.00%)  6/28 (21.43%) 
Impetigo * 1  0/27 (0.00%)  1/24 (4.17%)  1/28 (3.57%) 
Cellulitis * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Erysipelas * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Herpes simplex * 1  1/27 (3.70%)  0/24 (0.00%)  1/28 (3.57%) 
Herpes zoster * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Influenza * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Molluscum contagiosum * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Otitis externa * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Skin infection * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Tinea pedis * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Tonsillitis * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Upper respiratory tract infection * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Kaposi's varicelliform eruption * 1  1/27 (3.70%)  0/24 (0.00%)  1/28 (3.57%) 
Oral herpes * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Injury, poisoning and procedural complications       
Foot fracture * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Investigations       
Alanine aminotransferase increased * 1  1/27 (3.70%)  0/24 (0.00%)  2/28 (7.14%) 
Aspartate aminotransferase * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Blood bilirubin increased * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Blood creatine phosphokinase increased * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Intraocular pressure increased * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Hepatic enzyme increased * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Metabolism and nutrition disorders       
Hyperuricaemia * 1  1/27 (3.70%)  2/24 (8.33%)  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Bursitis * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Myalgia * 1  2/27 (7.41%)  0/24 (0.00%)  0/28 (0.00%) 
Pain in extremity * 1  2/27 (7.41%)  0/24 (0.00%)  0/28 (0.00%) 
Nervous system disorders       
Dizziness * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Headache * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  2/27 (7.41%)  1/24 (4.17%)  0/28 (0.00%) 
Rhinitis allergic * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic * 1  8/27 (29.63%)  4/24 (16.67%)  3/28 (10.71%) 
Pruritus * 1  0/27 (0.00%)  1/24 (4.17%)  1/28 (3.57%) 
Erythema ab igne * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Pain of skin * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Urticaria * 1  0/27 (0.00%)  1/24 (4.17%)  0/28 (0.00%) 
Skin induration * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Skin swelling * 1  0/27 (0.00%)  0/24 (0.00%)  1/28 (3.57%) 
Acne * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Rash * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Solar dermatitis * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
Xeroderma * 1  1/27 (3.70%)  0/24 (0.00%)  0/28 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Research
Organization: Janssen Research & Development, LLC.
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01945086    
Other Study ID Numbers: CR102538
First Submitted: September 13, 2013
First Posted: September 18, 2013
Results First Submitted: December 15, 2015
Results First Posted: March 9, 2016
Last Update Posted: March 9, 2016