Trial · NCT02698475

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

NCT02698475, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02698475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02698475

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02698475
Status: Completed
Phases: Phase 3
Enrollment: 44 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Psoriasis
Interventions: Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
First posted: 2016-03-03
Last updated: 2021-11-01
Other registries' IDs: eudract:2016-000121-40
Results first posted: 2020-08-28
Limitations and caveats: Due to the study design, the population was limited in the long-term extension period and decreased over time as participants met discontinuation criteria and exited the study.

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12	Week 12	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.
Secondary	Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12	Week 12	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 severity. 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.
Secondary	Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12	Baseline and Week 12	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.
Secondary	Percentage of Participants Who Achieved PASI 90 Response at Week 12	Week 12	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 severity. 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.
Secondary	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	Weeks 4, 8, 12, 16, 28, 40, and 52	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.
Secondary	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	Weeks 4, 8, 12, 16, 28, 40, and 52	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 severity. 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.
Secondary	Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52	Baseline and Weeks 4, 8, 12, 16, 28, 40, 52	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 severity. 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.
Secondary	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	Week 12	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 severity. 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.
Secondary	Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52	Baseline and Weeks 4, 12, 28, 52	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.
Secondary	Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1	Week 12	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 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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12	Week 12	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.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12	Week 12	FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12	Baseline and Week 12	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.	units on a scale	MEAN
SECONDARY	Percentage of Participants Who Achieved PASI 90 Response at Week 12	Week 12	FAS. Participants who met TF criteria prior to Week 12 or with missing data at Week 12 were considered non-responders at Week 12.	percentage of participants	NUMBER
SECONDARY	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	Weeks 4, 8, 12, 16, 28, 40, and 52	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.	percentage of participants	NUMBER
SECONDARY	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	Weeks 4, 8, 12, 16, 28, 40, and 52	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.	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline in PASI Score at Weeks 4, 8, 12, 16, 28, 40, and 52	Baseline and Weeks 4, 8, 12, 16, 28, 40, 52	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.	percent change	MEAN
SECONDARY	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	Week 12	FAS. Participants meeting one or more TF criteria were considered as non-responders.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Weeks 4, 12, 28, and 52	Baseline and Weeks 4, 12, 28, 52	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.	units on a scale	MEAN
SECONDARY	Percentage of Participants With a CDLQI Score of 0 or 1 at Week 12 in Participants With a Baseline CDLQI Score Greater Than (>) 1	Week 12	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.	percentage of participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group118

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12	Ustekinumab Standard Dose (Main Study)		77.3	95% Confidence Interval 62.2 to 88.5	percentage of participants
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12	Ustekinumab Standard Dosage (Main Study)		84.1	95% Confidence Interval 69.9 to 93.4	percentage of participants
Change From Baseline in Children Dermatology Life Quality Index (CDLQI) Score at Week 12	Ustekinumab Standard Dosage (Main Study)		-6.3	Standard Deviation 6.43	units on a scale
Percentage of Participants Who Achieved PASI 90 Response at Week 12	Ustekinumab Standard Dosage (Main Study)		63.6	95% Confidence Interval 47.8 to 77.6	percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 4: PGA Score 0	4.8		percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 4: PGA Score 0 or 1	33.3		percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 4: PGA Score 0 or 1 or 2	66.7		percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 8: PGA Score 0	26.8		percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 8: PGA Score 0 or 1	63.4		percentage of participants
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	Ustekinumab Standard Dosage (Main Study)	Week 8: PGA Score 0 or 1 or 2	85.4		percentage of participants

1 to 10 of 118Source ClinicalTrials.gov

See all 118 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Main Study Period	STARTED	Ustekinumab Standard Dosage	44
Main Study Period	COMPLETED	Ustekinumab Standard Dosage	41
Main Study Period	NOT COMPLETED	Ustekinumab Standard Dosage	3
Long-Term Extension Period	STARTED	Ustekinumab Standard Dosage	28
Long-Term Extension Period	COMPLETED	Ustekinumab Standard Dosage	0
Long-Term Extension Period	NOT COMPLETED	Ustekinumab Standard Dosage	28

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	Gastrointestinal disorders	Ustekinumab Standard Dosage (Main Study)	3	44
other	Abdominal Pain	Gastrointestinal disorders	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	0	28
other	Vomiting	Gastrointestinal disorders	Ustekinumab Standard Dosage (Main Study)	0	44
other	Vomiting	Gastrointestinal disorders	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	2	28
other	Injection Site Erythema	General disorders	Ustekinumab Standard Dosage (Main Study)	6	44
other	Injection Site Erythema	General disorders	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	2	28
other	Gastroenteritis	Infections and infestations	Ustekinumab Standard Dosage (Main Study)	3	44
other	Gastroenteritis	Infections and infestations	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	3	28
other	Nasopharyngitis	Infections and infestations	Ustekinumab Standard Dosage (Main Study)	11	44
other	Nasopharyngitis	Infections and infestations	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	8	28

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ustekinumab Standard Dosage (Main Study)	0	44
Total, all-cause mortality	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	0	28
Total, other adverse events	Ustekinumab Standard Dosage (Main Study)	27	44
Total, other adverse events	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	17	28
Total, serious adverse events	Ustekinumab Standard Dosage (Main Study)	3	44
Total, serious adverse events	Ustekinumab Standard Dosage (Long-Term Extension [LTE])	1	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36171515	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ustekinumab Standard Dosage (Main Study) vs Ustekinumab Standard Dosage (Long-Term Extension [LTE]): deaths from any cause	Trial comparisons
Ustekinumab Standard Dosage (Main Study) vs Ustekinumab Standard Dosage (Long-Term Extension [LTE]): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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