Clinical Trial Results:
A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy

Trial information Top of page
Trial identification
Sponsor protocol code	PsoPET2
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Aarhus University Hospital
Sponsor organisation address	Palle Juul-Jensens Boulevard 67, Aarhus N, Denmark, 8200
Public contact	Secretary M. Larsen, Aarhus University Hospital, 45 7846 1856, annebreg@rm.dk
Scientific contact	Secretary M. Larsen, Aarhus University Hospital, 45 7846 1856, annebreg@rm.dk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	02 Jul 2025
Is this the analysis of the primary completion data?	Yes
Primary completion date	02 Jul 2025
Global end of trial reached?	Yes
Global end of trial date	02 Jul 2025
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To assess the change in aortic wall inflammation from baseline to week 16 in brodalumab treated psoriasis subjects compared to placebo.
Protection of trial subjects	none
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	18 Dec 2017
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Denmark: 37
Worldwide total number of subjects	37
EEA total number of subjects	37
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	37
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	-
Pre-assignment period milestones
Number of subjects started	37
Number of subjects completed	37
Period 1
Period 1 title	Overall Trial (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Brodalumab
Arm description	-
Arm type	Active comparator
Investigational medicinal product name	Brodalumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Concentrate and solvent for solution for injection
Routes of administration	Subcutaneous use
Dosage and administration details	Inj Brodalumab 210 md s.c. week 0, week 1 and week 2 and from there every 2. week.
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	NaCl
Investigational medicinal product code
Other name
Pharmaceutical forms	Concentrate and solvent for solution for injection
Routes of administration	Subcutaneous use
Dosage and administration details	NaCL 1 Ml s.c. at 0, week 1 and week 2 and from then every 2. week
Number of subjects in period 1 Brodalumab Placebo Started 18 19 Completed 18 19

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Brodalumab
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Subject analysis set title	PSOPET2
Subject analysis set type	Per protocol
Subject analysis set description	Per protocol

End points Top of page

Primary: Aorta inflammation Top of page
End point title	Aorta inflammation [1]
End point description
End point type	Primary
End point timeframe	Baseline to week 16
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: In process by statistics
End point values Brodalumab PSOPET2 Number of subjects analysed 18 37 Units: TBRmax     number (not applicable) 18 37
Statistical analysis title	In process by statistics
Comparison groups	Brodalumab v PSOPET2
Number of subjects included in analysis	55
Analysis specification	Pre-specified
Analysis type	other
P-value	< 5
Method	Fisher exact
Confidence interval

Primary: Aorta inflammation Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	During trial with study medication.
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	1
Frequency threshold for reporting non-serious adverse events: 4%
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Correct

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
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.
None reported

More information Top of page