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An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age (CADMUS Jr)

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ClinicalTrials.gov Identifier: NCT02698475
Recruitment Status : Completed
First Posted : March 3, 2016
Results First Posted : August 28, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: Ustekinumab 0.75 mg/kg
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Enrollment 44
Recruitment Details  
Pre-assignment Details The results reported are for the main study (up to 56 weeks) and the long-term extension (LTE) results of the study will be reported once the study is completed.
Arm/Group Title Ustekinumab Standard Dosage
Hide Arm/Group Description Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56.
Period Title: Overall Study
Started 44
Ongoing 28
Completed 39
Not Completed 5
Reason Not Completed
Lack of Efficacy             1
Withdrawal by Subject             3
Protocol Violation             1
Arm/Group Title Ustekinumab Standard Dosage
Hide Arm/Group Description Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
8.9  (1.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
27
  61.4%
Male
17
  38.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Hispanic or Latino
3
   6.8%
Not Hispanic or Latino
41
  93.2%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Asian
1
   2.3%
Other
2
   4.5%
Unknown or Not Reported
1
   2.3%
White
40
  90.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Belgium
4
   9.1%
Canada
2
   4.5%
Germany
7
  15.9%
Hungary
10
  22.7%
Netherlands
1
   2.3%
Poland
12
  27.3%
United States
8
  18.2%
1.Primary Outcome
Title Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12
Hide Description The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. Treatment Failure (TF) criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all enrolled and treated participants who received at least 1 injection of ustekinumab (partial or complete). Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.3
(62.2 to 88.5)
2.Secondary Outcome
Title Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12
Hide Description PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severtiy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=75% improvement in PASI from baseline were considered PASI 75 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.1
(69.9 to 93.4)
3.Secondary Outcome
Title Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12
Hide Description CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. For participants meeting one or more TF criteria, were considered to have 0 improvement from baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this outcome measure at both baseline and Week 12.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.3  (6.43)
4.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 90 Response at Week 12
Hide Description PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severtiy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72 (disease severity). A higher score indicates more severe disease. Participants with >=90% improvement in PASI from baseline were considered PASI 90 responders. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.6
(47.8 to 77.6)
5.Secondary Outcome
Title Percentage of Participants With a PGA Score of Cleared (0), Cleared (0) or Minimal (1), Mild (2) at Weeks 4, 8, 12, 16, 28, 40, and 52
Hide Description The PGA is used to determine the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), marked (4), or severe (5). Higher scores indicate worse disease. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Weeks 4, 8, 12, 16, 28, 40, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
Week 4: PGA Score 0 Number Analyzed 42 participants
4.8
Week 4: PGA Score 0 or 1 Number Analyzed 42 participants
33.3
Week 4: PGA Score 0 or 1 or 2 Number Analyzed 42 participants
66.7
Week 8: PGA Score 0 Number Analyzed 41 participants
26.8
Week 8: PGA Score 0 or 1 Number Analyzed 41 participants
63.4
Week 8: PGA Score 0 or 1 or 2 Number Analyzed 41 participants
85.4
Week 12: PGA Score 0 Number Analyzed 44 participants
38.6
Week 12: PGA Score 0 or 1 Number Analyzed 44 participants
77.3
Week 12: PGA Score 0 or 1 or 2 Number Analyzed 44 participants
90.9
Week 16: PGA Score 0 Number Analyzed 42 participants
45.2
Week 16: PGA Score 0 or 1 Number Analyzed 42 participants
85.7
Week 16: PGA Score 0 or 1 or 2 Number Analyzed 42 participants
95.2
Week 28: PGA Score 0 Number Analyzed 42 participants
45.2
Week 28: PGA Score 0 or 1 Number Analyzed 42 participants
83.3
Week 28: PGA Score 0 or 1 or 2 Number Analyzed 42 participants
95.2
Week 40: PGA Score 0 Number Analyzed 42 participants
52.4
Week 40: PGA Score 0 or 1 Number Analyzed 42 participants
76.2
Week 40: PGA Score 0 or 1 or 2 Number Analyzed 42 participants
90.5
Week 52: PGA Score 0 Number Analyzed 41 participants
56.1
Week 52: PGA Score 0 or 1 Number Analyzed 41 participants
75.6
Week 52: PGA Score 0 or 1 or 2 Number Analyzed 41 participants
90.2
6.Secondary Outcome
Title Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 4, 8, 12, 16, 28, 40, and 52
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severtiy. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as >=50%, >=75%, >=90%, and 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Weeks 4, 8, 12, 16, 28, 40, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met 1 or more TF criteria were considered as non-responders after TF. In addition, participants with missing data at Week 12 were also considered as non-responders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
Week 4: PASI 100 Number Analyzed 42 participants
2.4
Week 4: PASI 90 Number Analyzed 42 participants
16.7
Week 4: PASI 75 Number Analyzed 42 participants
26.2
Week 4: PASI 50 Number Analyzed 42 participants
52.4
Week 8: PASI 100 Number Analyzed 41 participants
17.1
Week 8: PASI 90 Number Analyzed 41 participants
43.9
Week 8: PASI 75 Number Analyzed 41 participants
58.5
Week 8: PASI 50 Number Analyzed 41 participants
82.9
Week 12: PASI 100 Number Analyzed 44 participants
34.1
Week 12: PASI 90 Number Analyzed 44 participants
63.6
Week 12: PASI 75 Number Analyzed 44 participants
84.1
Week 12: PASI 50 Number Analyzed 44 participants
93.2
Week 16: PASI 100 Number Analyzed 42 participants
40.5
Week 16: PASI 90 Number Analyzed 42 participants
66.7
Week 16: PASI 75 Number Analyzed 42 participants
83.3
Week 16: PASI 50 Number Analyzed 42 participants
97.6
Week 28: PASI 100 Number Analyzed 42 participants
38.1
Week 28: PASI 90 Number Analyzed 42 participants
81.0
Week 28: PASI 75 Number Analyzed 42 participants
92.9
Week 28: PASI 50 Number Analyzed 42 participants
92.9
Week 40: PASI 100 Number Analyzed 42 participants
42.9
Week 40: PASI 90 Number Analyzed 42 participants
78.6
Week 40: PASI 75 Number Analyzed 42 participants
90.5
Week 40: PASI 50 Number Analyzed 42 participants
92.9
Week 52: PASI 100 Number Analyzed 41 participants
53.7
Week 52: PASI 90 Number Analyzed 41 participants
70.7
Week 52: PASI 75 Number Analyzed 41 participants
87.8
Week 52: PASI 50 Number Analyzed 41 participants
92.7
7.Secondary Outcome
Title Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severtiy. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 100 responders were defined as 100% improvement in PASI from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Baseline and Weeks 4, 8, 12, 16, 28, 40, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. For participants meeting one or more TF criteria, were considered to have 0% improvement from baseline. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: percent change
Week 4 Number Analyzed 42 participants
52.9  (27.33)
Week 8 Number Analyzed 41 participants
78.9  (21.44)
Week 12 Number Analyzed 42 participants
89.7  (13.80)
Week 16 Number Analyzed 42 participants
90.4  (13.77)
Week 28 Number Analyzed 42 participants
90.4  (21.55)
Week 40 Number Analyzed 42 participants
89.9  (23.01)
Week 52 Number Analyzed 41 participants
89.1  (24.28)
8.Secondary Outcome
Title Percentage of Participants Who Achieved PASI 100, PASI 90, PASI 75 or PASI 50 Response in PASI Components (Induration, Erythema, and Scaling) and Region Components (Head, Trunk, Upper Extremities, and Lower Extremities) at Week 12
Hide Description The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severtiy. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72 (disease severity). PASI 50, 75, 90, and 100 responders were defined as >=50%, >=75%, >=90%, and 100% improvement in PASI component from Baseline respectively. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants meeting one or more TF criteria were considered as non-responders.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
Induration: PASI 100 43.2
Induration: PASI 90 61.4
Induration: PASI 75 77.3
Induration: PASI 50 93.2
Scaling: PASI 100 38.6
Scaling: PASI 90 63.6
Scaling: PASI 75 84.1
Scaling: PASI 50 90.9
Erythema: PASI 100 38.6
Erythema: PASI 90 61.4
Erythema: PASI 75 81.8
Erythema: PASI 50 93.2
Head: PASI 100 52.3
Head: PASI 90 65.9
Head: PASI 75 79.5
Head: PASI 50 93.2
Trunk: PASI 100 61.4
Trunk: PASI 90 61.4
Trunk: PASI 75 79.5
Trunk: PASI 50 88.6
Upper extremities: PASI 100 65.9
Upper extremities: PASI 90 65.9
Upper extremities: PASI 75 79.5
Upper extremities: PASI 50 84.1
Lower extremities: PASI 100 68.2
Lower extremities: PASI 90 68.2
Lower extremities: PASI 75 72.7
Lower extremities: PASI 50 93.2
9.Secondary Outcome
Title Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52
Hide Description CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater the impairment in quality of life (QoL). TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Baseline and Weeks 4, 12, 28, 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 42 participants
-4.1  (4.88)
Week 12 Number Analyzed 42 participants
-6.3  (6.43)
Week 28 Number Analyzed 42 participants
-6.6  (5.79)
Week 52 Number Analyzed 41 participants
-6.4  (6.10)
10.Secondary Outcome
Title Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1
Hide Description was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with CDLQI score > 1 at baseline. Participants who met 1 or more TF criteria prior to Week 12 or with missing data were considered as nonresponders.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.5
(44.6 to 76.6)
11.Secondary Outcome
Title Percentage of Participants With a CDLQI Score of 0 or 1 at Weeks 4, 12, 28 and 52 in Participants With a Baseline CDLQI Score > 1
Hide Description CDLQI was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Weeks 4, 12, 28, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with CDLQI > 1 at baseline. Participants who met 1 or more TF criteria were considered as nonresponders after TF. In addition, participants with missing data at Week 12 were considered as nonresponders at Week 12. Here 'n' (number analyzed) included all participants who were evaluable at specified timepoints.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 Number Analyzed 37 participants
37.8
Week 12 Number Analyzed 39 participants
61.5
Week 28 Number Analyzed 37 participants
62.2
Week 52 Number Analyzed 36 participants
58.3
12.Secondary Outcome
Title Change From Baseline in CDLQI Component Scores at Week 12
Hide Description CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30. The total score ranges from 0 to 30. The higher the score, the greater impairment in quality of life. TF criteria- discontinued study agent due to lack of efficacy or adverse event of psoriasis or who started protocol-prohibited medication/therapy.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Participants who met TF criteria prior to Week 12 were assigned 0 change. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.
Arm/Group Title Ustekinumab Standard Dose
Hide Arm/Group Description:
Participants received ustekinumab -standard weight-based dose at Weeks 0 and 4 followed by q12w dosing up to Week 40. Ustekinumab was administered as SC injections of 0.75 mg/kg for participants with weight <60 kg, 45 mg for participants with weight >=60 kg to <=100 kg, and 90 mg for participants with weight >100 kg. Participants had a safety follow-up till Week 56.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptoms and feelings -1.9  (1.81)
Leisure -1.7  (2.19)
School or holidays -0.5  (0.80)
Personal relationships -0.8  (1.71)
Sleep -0.4  (0.91)
Treatment -0.9  (1.14)
Time Frame Up to Week 56
Adverse Event Reporting Description The safety analysis set included all the enrolled participants who received at least 1 injection of ustekinumab (partial or complete) during the study.
 
Arm/Group Title Ustekinumab Standard Dosage
Hide Arm/Group Description Participants received ustekinumab standard weight-based dose at Weeks 0 and 4 followed by every 12 weeks (q12w) dosing up to Week 40. Ustekinumab was administered as subcutaneous (SC) injections of 0.75 milligrams per kilogram (mg/kg) for participants with weight less than (<) 60 kilograms (kg), 45 mg for participants with weight greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg, and 90 mg for participants with weight > 100 kg. Participants had a safety follow-up till Week 56.
All-Cause Mortality
Ustekinumab Standard Dosage
Affected / at Risk (%)
Total   0/44 (0.00%) 
Hide Serious Adverse Events
Ustekinumab Standard Dosage
Affected / at Risk (%)
Total   3/44 (6.82%) 
Infections and infestations   
Infectious Mononucleosis * 1  1/44 (2.27%) 
Injury, poisoning and procedural complications   
Eyelid Injury * 1  1/44 (2.27%) 
Psychiatric disorders   
Attention Deficit/Hyperactivity Disorder * 1  1/44 (2.27%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ustekinumab Standard Dosage
Affected / at Risk (%)
Total   27/44 (61.36%) 
Gastrointestinal disorders   
Abdominal Pain * 1  3/44 (6.82%) 
General disorders   
Injection Site Erythema * 1  6/44 (13.64%) 
Infections and infestations   
Gastroenteritis * 1  3/44 (6.82%) 
Nasopharyngitis * 1  11/44 (25.00%) 
Otitis Media * 1  3/44 (6.82%) 
Pharyngitis * 1  6/44 (13.64%) 
Tonsillitis * 1  4/44 (9.09%) 
Upper Respiratory Tract Infection * 1  6/44 (13.64%) 
Skin and subcutaneous tissue disorders   
Psoriasis * 1  3/44 (6.82%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
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.
If an investigator wishes to publish information from the study, 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 by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02698475    
Other Study ID Numbers: CR108129
CNTO1275PSO3013 ( Other Identifier: Janssen Research & Development, LLC )
2016-000121-40 ( EudraCT Number )
First Submitted: February 29, 2016
First Posted: March 3, 2016
Results First Submitted: August 12, 2020
Results First Posted: August 28, 2020
Last Update Posted: November 18, 2020