Clinical Trial Results:
Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants
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Summary
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EudraCT number |
2021-005085-18 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
26 Jan 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Aug 2024
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First version publication date |
07 Aug 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CNTO1275ISD1001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05252533 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, B-2340
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Mar 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Jan 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of trial was to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 May 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
9
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Adolescents (12-17 years) |
22
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 31 subjects were enrolled in this study. Of these, 11 subjects were enrolled under disease cohort 1: Juvenile Psoriatic Arthritis (jPsA), and 20 subjects under disease cohort 2: Pediatric Psoriasis (PsO). | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort 1: Juvenile Psoriatic Arthritis (jPsA) | |||||||||||||||||||||
Arm description |
Subjects (aged greater than or equal to [>=] 5 to less than [<] 18 years) who were previously diagnosed with jPsA and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating health care professional (HCP). | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Ustekinumab
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Investigational medicinal product code |
CNTO 1275
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Other name |
STELARA
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects who were previously diagnosed with jPsA and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP.
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Arm title
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Cohort 2: Pediatric Psoriasis (PsO) | |||||||||||||||||||||
Arm description |
Subjects (aged >=5 to <18 years) who were previously diagnosed with PsO and treated with ustekinumab were enrolled this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Ustekinumab
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Investigational medicinal product code |
CNTO 1275
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Other name |
STELARA
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects who were previously diagnosed with PsO and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP.
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Baseline characteristics reporting groups
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Reporting group title |
Cohort 1: Juvenile Psoriatic Arthritis (jPsA)
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Reporting group description |
Subjects (aged greater than or equal to [>=] 5 to less than [<] 18 years) who were previously diagnosed with jPsA and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating health care professional (HCP). | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 2: Pediatric Psoriasis (PsO)
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Reporting group description |
Subjects (aged >=5 to <18 years) who were previously diagnosed with PsO and treated with ustekinumab were enrolled this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort 1: Juvenile Psoriatic Arthritis (jPsA)
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Reporting group description |
Subjects (aged greater than or equal to [>=] 5 to less than [<] 18 years) who were previously diagnosed with jPsA and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating health care professional (HCP). | ||
Reporting group title |
Cohort 2: Pediatric Psoriasis (PsO)
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Reporting group description |
Subjects (aged >=5 to <18 years) who were previously diagnosed with PsO and treated with ustekinumab were enrolled this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP. | ||
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End point title |
Observed Serum Concentration of Ustekinumab [1] | ||||||||||||
End point description |
Observed serum concentration of ustekinumab were reported. Pharmacokinetic (PK) analysis set included all enrolled subjects who received ustekinumab and had at least 1 sample drawn for PK analysis.
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End point type |
Primary
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End point timeframe |
Cumulative PK samples from visits 1-4 (from Week 0 [baseline] up to Week 20)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects with Treatment-emergent Serious Adverse Events (SAEs) | |||||||||
End point description |
Number of subjects with treatment-emergent SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalisation; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAEs that occurred after signing of ICF up to end of study. Safety analysis set included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
From Week 0 (Baseline) up to end of study (up to 20 weeks)
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects with Treatment-emergent Adverse Events (AEs) | |||||||||
End point description |
Number of subjects with TEAEs were reported. An adverse event (AE) is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were those AEs that occurred after signing of informed consent form (ICF) up to end of study. Safety analysis set included all subjects enrolled in the study.
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End point type |
Secondary
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End point timeframe |
From Week 0 (Baseline) up to end of study (up to 20 weeks)
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From Week 0 (Baseline) up to end of study (up to 20 weeks)
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Adverse event reporting additional description |
Safety analysis set included all subjects enrolled in the study.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Cohort 2: Pediatric Psoriasis (PsO)
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Reporting group description |
Subjects (aged >=5 to <18 years) who were previously diagnosed with PsO and treated with ustekinumab were enrolled this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating HCP. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort 1: Juvenile Psoriatic Arthritis (jPsA)
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Reporting group description |
Subjects (aged greater than or equal to [>=] 5 to less than [<] 18 years) who were previously diagnosed with jPsA and treated with ustekinumab were enrolled in this study and continued ustekinumab at the dose and frequency prescribed as per discretion of their treating health care professional (HCP). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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08 Sep 2022 |
The rational of this amendment was to address the recent Food and Drug Administration (FDA) approval of STELARA in juvenile psoriatic arthritis (jPsA) in children ages 6 and above, changes were made to align with the United States (US) label. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Limited safety data due to small sample size and short study duration. Limited interpretation of PK data due to the opportunistic study design (with variable dosing schedules), use of historical dosing records, and real-world dosing of ustekinumab. | |||
