Clinical Trial Results:
A Phase 4, Interventional, Single-arm, Open-label Study Evaluating the Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants with Moderate to Severe Plaque Psoriasis
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Summary
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EudraCT number |
2020-004061-39 |
Trial protocol |
DE SE GR IT |
Global end of trial date |
28 Jul 2023
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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 |
CNTO1959PSO4015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05125679 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen-Cilag Limited
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, B-2340
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Public contact |
Clinical Registry Group, Janssen-Cilag Limited, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen-Cilag Limited, 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 |
23 Oct 2023
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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 |
28 Jul 2023
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The main objective of the study was to evaluate the effect of guselkumab on coronary flow reserve (CFR) measured by transthoracic doppler-echocardiography, in subjects with moderate-to-severe psoriasis and intermediate cardiovascular risk (ICR, defined by CFR greater than or equal to [>=] 2 and less than or equal to [<=] 3.5 at second screening visit 2 [2 to 4 weeks prior to Week 0]).
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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 |
23 Nov 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Germany: 4
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Country: Number of subjects enrolled |
Greece: 7
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Country: Number of subjects enrolled |
Italy: 4
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 15 subjects with moderate-to-severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months prior to the first dose of guselkumab at Week 0 (baseline) of the study entry were enrolled and treated with at least one dose of guselkumab. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
One subject of arm "Guselkumab 100 mg: Nicotine Users" who was treated with adenosine during the screening period was considered as screen failure but was counted in the safety analysis set (N=16) alone and not included in Full analysis set (N=15). | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall (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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Guselkumab 100 mg (Nicotine Users) | |||||||||||||||||||||
Arm description |
Subjects who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20 and 28. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Guselkumab
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Investigational medicinal product code |
CNTO1959
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Other name |
TREMFYA
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A single dose of guselkumab 100 mg at weeks 0, 4, 12, 20 and 28.
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Arm title
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Guselkumab 100 mg (Non-Nicotine Users) | |||||||||||||||||||||
Arm description |
Subjects who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20 and 28. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Guselkumab
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Investigational medicinal product code |
CNTO1959
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Other name |
TREMFYA
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
A single dose of guselkumab 100 mg injection at weeks 0, 4, 12, 20 and 28.
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Subjects who had CFR value greater than or equal to (>=) 2 and less than or equal to (<=) 3.5 at screening Visit 2 were included. |
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Baseline characteristics reporting groups
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Reporting group title |
Guselkumab 100 mg (Nicotine Users)
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Reporting group description |
Subjects who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20 and 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Guselkumab 100 mg (Non-Nicotine Users)
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Reporting group description |
Subjects who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20 and 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Guselkumab 100 mg (Nicotine Users)
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Reporting group description |
Subjects who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20 and 28. | ||
Reporting group title |
Guselkumab 100 mg (Non-Nicotine Users)
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Reporting group description |
Subjects who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20 and 28. | ||
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End point title |
Change from Baseline in Coronary Flow Reserve (CFR) at Week 32 [1] | ||||||||||||
End point description |
Change from baseline in CFR at Week 32 were reported. CFR described ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography with administration of adenosine 140 micrograms per kilogram per minute (mcg/kg/min) as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during adenosine infusion (for 5 minutes). CFR is ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated and evaluable subjects with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Primary
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End point timeframe |
Baseline (Week 0) and Week 32
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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: Due to too small number of enrolled subjects, no meaningful statistical comparisons between groups could be performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR at Week 16 | ||||||||||||
End point description |
Change from baseline in CFR at Week 16 were reported. CFR described ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography with administration of adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during adenosine infusion (for 5 minutes). CFR is the ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated and evaluable subjects with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Absolute Global Longitudinal Strain (GLS) at Week 16 | ||||||||||||
End point description |
Change from baseline in absolute GLS at Week 16 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Absolute GLS at Week 32 | ||||||||||||
End point description |
Change from baseline in absolute GLS at Week 32 were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 16 | ||||||||||||
End point description |
Change from baseline in cfPWV at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in cfPWV at Week 32 | ||||||||||||
End point description |
Change from baseline in cfPWV at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV = distance (meters) / transit time (seconds). FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 and <=3.5 at screening visit 2 (2 to 4 weeks prior to Week 0) and baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR at Week 16 Among Subjects with CFR >=2 to Less than (<)2.75 at Baseline | ||||||||||||
End point description |
Change from baseline in CFR at Week 16 among subjects with CFR >=2 to <2.75 at baseline were reported. CFR: ability of coronary blood flow to increase substantially when required by metabolic demands, which might be 4 to 5 times greater during normal exercise than resting, and even more with pharmacological agents. CFR was measured using transthoracic doppler echocardiography with adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during adenosine infusion (for 5 minutes). CFR: ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 to <2.75 at baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| Notes [2] - Here, N=0, indicates that no subjects had baseline CFR measurement of >=2 to <2.75. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR at Week 32 Among Subjects with CFR >=2 to <2.75 at Baseline | ||||||||||||
End point description |
Change from baseline in CFR at Week 32 among subjects with CFR >=2 to <2.75 at baseline were reported. CFR: ability of coronary blood flow to increase substantially when required by metabolic demands, which might be 4 to 5 times greater during normal exercise than resting, and even more with pharmacological agents. CFR was measured using transthoracic doppler echocardiography with adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during administration of adenosine infusion (for 5 minutes). CFR: ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2 to <2.75 at baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| Notes [3] - Here, N=0, indicates that no subjects had baseline CFR measurement of >=2 to <2.75. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR at Week 16 Among Subjects with CFR >=2.75 to <=3.5 at Baseline | ||||||||||||
End point description |
Change from baseline in CFR at Week 16 among subjects with CFR >=2.75 to <=3.5 at baseline were reported. CFR: ability of coronary blood flow to increase substantially when required by metabolic demands, which might be 4 to 5 times greater during normal exercise than resting, and even more with pharmacological agents. CFR was measured using transthoracic doppler echocardiography with adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during administration of adenosine infusion (for 5 minutes). CFR: ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2.75 to <=3.5 at baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| Notes [4] - Here, N=0 indicates that no subjects had baseline CFR measurement of >=2.75 to <=3.5. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 16 | ||||||||||||
End point description |
Change from baseline in absolute GLS at Week 16 among nicotine users and non-nicotine users were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 32 | ||||||||||||
End point description |
Change from baseline in CFR at Week 32 among nicotine users and non-users were reported. CFR described ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography with administration of adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during administration of adenosine infusion (for 5 minutes). CFR is the ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR Among Nicotine Users and Non-nicotine Users at Weeks 16 | ||||||||||||
End point description |
Change from baseline in CFR among nicotine users and non-users at Week 16 were reported. CFR described ability of coronary blood flow to increase substantially when required by metabolic demands, which might be up to 4 to 5 times greater during normal exercise compared to resting, and even greater with administration of pharmacological agents. CFR was measured non-invasively using transthoracic doppler echocardiography with administration of adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during administration of adenosine infusion (for 5 minutes). CFR is ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in CFR at Week 32 Among Subjects with CFR >=2.75 to <=3.5 at Baseline | ||||||||||||
End point description |
Change from baseline in CFR at Week 32 among subjects with CFR >=2.75 to <=3.5 at baseline were reported. CFR: ability of coronary blood flow to increase substantially when required by metabolic demands, which might be 4 to 5 times greater during normal exercise than resting, and even more with pharmacological agents. CFR was measured using transthoracic doppler echocardiography with adenosine 140 mcg/kg/min as vasodilator. Doppler signals were recorded continuously at baseline (Week 0) and during administration of adenosine infusion (for 5 minutes). CFR: ratio of blood flow at stress during maximal dilation of coronary arteries to blood flow at rest. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of treated subjects evaluable for this endpoint with ICR defined by CFR >=2.75 to <=3.5 at baseline (Week 0).
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| Notes [5] - Here, N=0 indicates that no subjects had baseline CFR measurement of >=2.75 to <=3.5. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in cfPWV Among Nicotine Users and Non-users at Week 16 | ||||||||||||
End point description |
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 16 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 16
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in Absolute GLS Among Nicotine Users and Non-users at Week 32 | ||||||||||||
End point description |
Change from baseline in absolute GLS at Week 32 among nicotine users and non-nicotine users were reported. GLS is a myocardial deformation analysis that predominantly reflects the function of sub-endocardial longitudinally oriented fibers, which are most prone to ischemic damage and wall stress. The GLS is calculated at systole and diastole. Speckle tracking echocardiography (STE) were employed for the detection of left-ventricular (LV) myocardial strain. GLS is a measure of longitudinal shortening of the myocardium as a percentage (change in length as a proportion to baseline length), thus explaining the negative values. FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change from Baseline in cfPWV Among Nicotine Users and Non-users at Week 32 | ||||||||||||
End point description |
Change from baseline in cfPWV among nicotine users and non-nicotine users at Week 32 were reported. cfPWV is a direct measurement, and the most simple, non-invasive, robust, and reproducible method to determine arterial stiffness. cfPWV was determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. cfPWV was calculated as cfPWV= distance (meters)/ transit time (seconds). FAS included all subjects who received at least 1 dose of guselkumab. Here, 'N' (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 32
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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 (TEAEs) | |||||||||
End point description |
Number of subjects with TEAEs among subjects treated with guselkumab were reported. An adverse event (AE) was 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. Any AE occurring at or after administration of adenosine or the initial administration of study intervention (guselkumab) through the day of last dose within the study phase plus 12 weeks or the date of the Final Safety visit, whichever was the latest, was considered to be TEAE. The safety analysis set included all subjects who received at least 1 dose of study treatment (either guselkumab or and adenosine) during study period.
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End point type |
Secondary
|
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End point timeframe |
Week 0 up to 12 weeks post last dose of study drug (up to Week 40)
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| Notes [6] - 1 subject treated with adenosine (screen failure) was also counted in safety analysis set, thus N=8. |
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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 |
Week 0 Up to 12 weeks post last dose of study drug (up to Week 40)
|
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Adverse event reporting additional description |
The safety analysis set included all subjects who received at least 1 dose of study treatment (either guselkumab or and adenosine) during study period. One subject of arm "Guselkumab 100 mg: Nicotine Users" who was treated with adenosine during screening period was considered as screen failure but was counted in safety analysis set (N=16) alone.
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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 |
26.0
|
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Reporting groups
|
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Reporting group title |
Guselkumab 100 mg (Nicotine Users)
|
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Reporting group description |
Subjects who were nicotine users (who had used tobacco products and/or nicotine products) received guselkumab 100 milligrams (mg) subcutaneous (SC) injection at Weeks 0, 4, 12, 20 and 28. | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Guselkumab 100 mg (Non-nicotine Users)
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Reporting group description |
Subjects who were non-nicotine users (who had refrained from using tobacco/nicotine products for at least 3 months prior to screening visit 1 [4 to 6 weeks prior to Week 0]) received guselkumab 100 mg SC injection at Weeks 0, 4, 12, 20 and 28. | |||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
12 May 2021 |
The purpose of this amendment was to include tests and measurements to screen study subjects for metabolic syndrome. In addition, the method used for calculation of body surface area (BSA) affected by psoriasis was updated, and the latest versions of the patient reported outcomes (PRO) questionnaires were added to the protocol. |
||
13 May 2022 |
The purpose of this amendment was to ensure exclusion criterion regarding low density lipoprotein (LDL) cutoff value (above which statin therapy should be initiated) was in line with the guidelines for management of dyslipidemia by the European Society of Cardiology. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Sponsor terminated the study solely due to lack of enrolment. Due to small number of enrolled subjects, it was not possible to evaluate the primary or secondary objectives for this study as planned. | |||
