Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44356   clinical trials with a EudraCT protocol, of which   7382   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial

    Summary
    EudraCT number
    		 2020-000711-76
    Trial protocol
    		 DK  
    Global end of trial date
    25 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2025
    First version publication date
    16 Aug 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    N/A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexander Egeberg, Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 23, Copenhagen, Denmark,
    Public contact
    Bispebjerg Hospital, Alexander Egeberg, alexander.egeberg@gmail.com
    Scientific contact
    Bispebjerg Hospital, Alexander Egeberg, alexander.egeberg@gmail.com
    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
    25 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of roflumilast in the treatment of psoriasis (PASI75)
    Protection of trial subjects
    Regulatory approvals were obtained from The Scientific Ethics Committee of the Capital Region of Denmark (H-20013697), the Danish Medicine Agency, and the Danish Data Protection Agency. The trial was registered at EudraCT (2020-000711-76) and conducted in accordance with national data protection acts and the Edinburgh, Scotland, amendment (2000) to the Declaration of Helsinki 1964. Monitoring was performed by the Good Clinical Practice (GCP) units at University of Copenhagen and Aarhus University, Denmark.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jul 2020
    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: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    23
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from study sites and dermatology private practices, and through advertising.

    Pre-assignment
    Screening details
    		 Inclusion criteria were age ≥18 years, chronic stable plaque psoriasis (min. six months duration), psoriasis area and severity index (PASI) ≥8, body mass index (BMI) ≥20 kg/m2, indication for systemic treatment of psoriasis, and safe anticonception during the study period (...) For further details, please see published paper.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 n=18 particiants completed w12. n=5 were failure due to e.g. AEs. There seems to be a technical problem with the software, as the information is not by the system. Please see published paper for more details.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 microgram once-daily

    Arm title
    		 Placebo
    Arm description
    		 n=22 particiants completed w12. n=1 were failure due to AEs. There seems to be a technical problem with the software, as this information cannot be accepted by the system. Please see published paper for more details.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft + tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once-daily

    Number of subjects in period 1
    		Active Placebo
    Started
    23
    23
    Completed
    23
    23

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 46 46
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 23 23
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 34 34

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 n=18 particiants completed w12. n=5 were failure due to e.g. AEs. There seems to be a technical problem with the software, as the information is not by the system. Please see published paper for more details.

    Reporting group title
    Placebo
    Reporting group description
    		 n=22 particiants completed w12. n=1 were failure due to AEs. There seems to be a technical problem with the software, as this information cannot be accepted by the system. Please see published paper for more details.

    Primary: PASI75

    		 Close Top of page
    End point title
    		 PASI75
    End point description
    The primary study endpoint was defined as the proportion of patients achieving at least 75% reduction from baseline PASI (PASI75) at week 12.
    End point type
    Primary
    End point timeframe
    w0-12
    End point values
    		 Active Placebo
    Number of subjects analysed
    23
    23
    Units: %
    23
    23
    Statistical analysis title
    		 See below
    Statistical analysis description
    Continuous variables were presented as means and standard deviations (SD) (normally distributed data) or medians and interquartile ranges (IQR) (non-normally distributed data). Categorical variables were reported as frequencies and percentages. Efficacy data were assessed by intention to treat (..) For further details, se published paper.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 5
    Method
    		 N/A
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    w0-96
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: No SAEs were reported, and no significant biochemical changes were observed.

    More information

    		 Close 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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Aug 21 06:00:38 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA