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    Clinical Trial Results:
    Treatment of patients with Lichen planus with the JAK-Inhibitor Upadacitinib (Rinvoq®) – a mono-centered double-blinded placebo controlled randomized pilot study (investigator-initiated trial)

    Summary
    EudraCT number
    		 2021-006031-25
    Trial protocol
    		 DE  
    Global end of trial date
    17 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2025
    First version publication date
    11 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UPALI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Studienzentrale, AG Worm, Charité - Universitätsmedizin Berlin, Allergy Center Charité, +49 30 450518305, acc-studien@charite.de
    Scientific contact
    Studienzentrale, AG Worm, Charité - Universitätsmedizin Berlin, Allergy Center Charité, +49 30 450518305, acc-studien@charite.de
    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
    06 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of upadacitinib (Rinvoq®) therapy in patients with Lichen planus.
    Protection of trial subjects
    The conduct of this study met all legal and regulatory requirements and in accordance with ethical principles of the Declaration of Helsinki.
    Background therapy
    		 Patients with Lichen planus (LP) show a presence of a strong Th1/Th17 signature. Preliminary data revealed an overactivation of the JAK/STAT Pathway in LP, with hyperactivation of various STAT proteins (STAT1, STAT2, STAT3, STAT4, STAT5). These encouraging results enforce the concept that the use of Janus kinase (JAK) inhibitors in LP could help patients for which present treatments are often not sufficient and help physicians by offering a new possible treatment solution for an often recalcitrant and frustrating disorder. JAKs are intracellular enzymes that transmit signals from cytokines and growth factors involved in a variety of cellular processes such as inflammatory responses, hematopoiesis, and immune surveillance. The JAK enzyme family comprises four members - JAK1, JAK2, JAK3 and TYK2 - which phosphorylate and thereby activate STATs in pairs. This phosphorylation in turn modulates gene expression and cell function. JAK1 is important for inflammatory cytokine signaling pathways, while JAK2 is important for erythrocyte maturation, and JAK3 signals play a role in immune monitoring and lymphocyte function. Upadacitinib is a selective and reversible JAK inhibitor. In human cell-based assays, upadacitinib preferentially inhibits JAK1 or JAK1/3 signaling pathways compared to other cytokine signaling pathways that are mediated via JAK2 pairs.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2022
    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
    Germany: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    13
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 1 study center in Germany between 10/08/2022 and 17/12/2024.

    Pre-assignment
    Screening details
    		 Patients with diagnosis of acute or chronic (>3 months) Lichen planus, with Investigator Global Assessment (IGA) score ≥ 3 and with a clinical presentation and histopathology consistent (performed within 6 months prior to screening) and with at least one target lesion of oral lichen planus were screened.

    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
    		 Investigator, Subject, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Upadacitinib
    Investigational medicinal product code
    L04AA44
    Other name
    Rinvoq®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 15 mg Upadacitinib per day about 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received placebo per day about 12 weeks

    Number of subjects in period 1
    		Verum Placebo
    Started
    8
    6
    Completed
    6
    6
    Not completed
    2
    0
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Verum Placebo Total
    Number of subjects
    		 8 6 14
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 7 6 13
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50 ( 9 ) 51 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 2 8
        Male
    		 2 4 6
    IGA
    Investigator Global Assessment (IGA) for atopic dermatitis.
    Units: Subjects
        IGA severe
    		 4 1 5
        IGA moderate
    		 4 5 9
    DLQI
    Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person.
    Units: score
        arithmetic mean (standard deviation)
    		 8.5 ( 6.19 ) 4 ( 1.26 ) -
    Itch NRS
    Itch NRS (Numerical Rating Scale ) is a single item designed to capture information on self-reported severity of worst itching each day.
    Units: Score
        arithmetic mean (standard deviation)
    		 3.38 ( 4.0 ) 1.33 ( 3.27 ) -
    Pain VAS
    Pain on Visual Analogue Scale (VAS)
    Units: Score
        arithmetic mean (standard deviation)
    		 35.57 ( 16.73 ) 35.0 ( 19.28 ) -
    PSA
    Participant self-assessment
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 4 (3 to 4) 3.5 (1.75 to 5) -
    PSAD
    Medical assessment of the disease surface.
    Units: score
        median (inter-quartile range (Q1-Q3))
    		 3.5 (3 to 4.75) 4 (3 to 4.25) -

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: clinical response (IGA) in mucosal disease

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    End point title
    		 clinical response (IGA) in mucosal disease [1]
    End point description
    End point type
    Primary
    End point timeframe
    at week 12
    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 the small number of patients, a statistical evaluation was only planned descriptively.
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: subjects
        IGA ≤ 1
    3
    0
        IGA >1
    3
    6
    No statistical analyses for this end point

    Secondary: Change in DLQI

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    End point title
    		 Change in DLQI
    End point description
    Change in Dermatology Life Quality Index (DLQI), evaluation DLQI: week 4, 8, and 12.
    End point type
    Secondary
    End point timeframe
    from baseline up to 12 weeks
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: score
    arithmetic mean (standard deviation)
        week 4
    7.5 ( 5.58 )
    2.83 ( 2.32 )
        week 8
    5.17 ( 4.07 )
    4.5 ( 2.89 )
        week 12
    4.67 ( 3.89 )
    5.0 ( 3.29 )
    No statistical analyses for this end point

    Secondary: Change in Itch

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    End point title
    		 Change in Itch
    End point description
    Change in patient assessment of pruritus (itching) (NRS 1-10), evaluation: week 4,8,12
    End point type
    Secondary
    End point timeframe
    from baseline up to 12 weeks
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: score
    arithmetic mean (standard deviation)
        week 4
    2.17 ( 3.06 )
    2.6 ( 3.71 )
        week 8
    1.33 ( 1.63 )
    2.5 ( 3.89 )
        week 12
    0.83 ( 0.98 )
    3.0 ( 4.69 )
    No statistical analyses for this end point

    Secondary: Change in pain VAS

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    End point title
    		 Change in pain VAS
    End point description
    Change in patient assessment of pain (VAS 0-100), evaluation: week 4, 8, 12
    End point type
    Secondary
    End point timeframe
    from baseline up to 12 weeks
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: score
    arithmetic mean (standard deviation)
        week 4
    38 ( 28.94 )
    44.6 ( 24.52 )
        week 8
    28.2 ( 19.0 )
    44.67 ( 28.05 )
        week 12
    25 ( 14.36 )
    33.4 ( 20.86 )
    No statistical analyses for this end point

    Secondary: Change in PSA

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    End point title
    		 Change in PSA
    End point description
    Change in Participant Self-Assessment (PSA), evaluation: week 4,8,12
    End point type
    Secondary
    End point timeframe
    from baseline up to 12 weeks
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: Score
    median (inter-quartile range (Q1-Q3))
        week 4
    4 (3.5 to 4.5)
    4 (3 to 5)
        week 8
    3.5 (1.75 to 4.25)
    3 (1.75 to 4.25)
        week 12
    2.5 (1 to 3.25)
    3.5 (1.75 to 4.25)
    No statistical analyses for this end point

    Secondary: Change in PSAD

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    End point title
    		 Change in PSAD
    End point description
    Change in Physician Assessment of Surface Area of Disease (PSAD), evaluation: week 4,8,12
    End point type
    Secondary
    End point timeframe
    from baseline up to 12 weeks
    End point values
    		 Verum Placebo
    Number of subjects analysed
    6
    6
    Units: score
    median (inter-quartile range (Q1-Q3))
        week 4
    3 (2.75 to 4.25)
    4 (3 to 4.25)
        week 8
    2.5 (1.5 to 4)
    4 (2.75 to 4)
        week 12
    2 (1.5 to 3.25)
    3.5 (3 to 4.25)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline up to 12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    5 / 6 (83.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    epithelial dysplasia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Flu like symptoms
         subjects affected / exposed
    3 / 8 (37.50%)
    3 / 6 (50.00%)
         occurrences all number
    4
    4
    local skin reaction
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    loose teeth
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Gastroesophageal reflux disease
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    Cheilitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Amenorrhea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Sore throat
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Rash acneiform
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Arthritis
    Additional description: gout symptoms
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Covid 19
    Additional description: SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    fungal infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    soft tissue infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 6 (33.33%)
         occurrences all number
    1
    2

    More information

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    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.

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