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    Clinical Trial Results:
    Efficacy and tolerance of the association of Baricitinib (4mg) and phototherapy versus phototherapy in adults with progressive vitiligo: a randomized double blind prospective study

    Summary
    EudraCT number
    		 2020-005079-12
    Trial protocol
    		 FR  
    Global end of trial date
    24 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2026
    First version publication date
    26 Jun 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CHUBX2019/21
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04822584
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Bordeaux
    Sponsor organisation address
    12 rue Dubernat, Talence, France, 33400
    Public contact
    Julien SENESCHAL, Centre Hospitalier Universitaire de Bordeaux, +33 05 56 79 49 63, julien.seneschal@chu-bordeaux.fr
    Scientific contact
    Julien SENESCHAL, Centre Hospitalier Universitaire de Bordeaux, +33 05 56 79 49 63, julien.seneschal@chu-bordeaux.fr
    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
    27 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of the combination of baricitinib (orally) 4 mg/d + UVB TL01 (twice a week) by evaluating the percentage of skin repigmentation after 36 weeks of treatment using the VASI score in patients with vitiligo.
    Protection of trial subjects
    The important identified and important potential risks are recognized for baricitinib and will be followed carefully in this study. Immediate risks associated with phototherapy are the occurrence of erythema that will be evaluated at each phototherapy visit. Long-term risks are cataract risk that will be prevented by wearing safety glasses. The risk of genital skin carcinoma will be prevented by wearing underclothes. The coordinating investigator will constantly monitor, assess and document risks and ensure that they can be managed satisfactorily. The investigator is responsible for the reporting of adverse events which occur from the date of signature of the consent until the end of participation of the patient. In this study, all the adverse events must be reported. In some circumstances, it may be necessary to temporarily interrupt treatment as a result of AEs or abnormal laboratory values that may have an unclear relationship to investigational product. In those cases investigational product may be restarted at the discretion of the investigator. In order to ensure the safety of the participants, the following therapies will not be permitted during the course of the study : therapies that could induce photosensitivity, high exposition to natural sun. An dermatological exam (to verify the absence of other skin disorders associated with vitiligo and the absence of skin carcinoma/melanoma) will be performed at each visits : randomisation visit, follow-up visit at week 12, follow-up visit at week 24, end of treatment visit (week 36), end of study visit (week 48)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    47
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment will be carried out within the out-patient setting in the different Departments of Dermatology participating in the study.

    Pre-assignment
    Screening details
    		 In total, 61 patients were selected, of which 49 were randomized

    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, Assessor
    Blinding implementation details
    Recruitment will be carried out within the out-patient setting in the different Departments of Dermatology participating in the study. A feasibility study regarding inclusion and non inclusion criteria has been conducted in these four departments, with a great expertise in the management of vitiligo, to ensure that a sufficient number of patients could be included in this research protocol. The four departments have access to blood and skin samples from vitiligo patients. It is important to me

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baricitinib
    Arm description
    		 The treatment evaluated is baricitinib at a dosage of 4 mg/day for 36 weeks, combined with phototherapy twice a week started 12 weeks after the start of baricitinib and continued for 24 weeks. We have decided to test the higher dose currently tested in another chronic inflammatory skin disorders called atopic dermatitis that showed in phase II and phase III significant efficacy with a good safety profile. Dosage schedule: 4 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BARICITINIB
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily dosing for 36 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo of baricitinib associated with UVB TL01 phototherapy will be used. Placebo of baricitinib will be started 12 weeks before the start of phototherapy and will be continued for 36 weeks.
    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
    1 tablet per day until 36 weeks

    Number of subjects in period 1
    		Baricitinib Placebo
    Started
    37
    12
    Completed
    33
    9
    Not completed
    4
    3
         Consent withdrawn by subject
    3
    1
         Physician decision
    1
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baricitinib
    Reporting group description
    		 The treatment evaluated is baricitinib at a dosage of 4 mg/day for 36 weeks, combined with phototherapy twice a week started 12 weeks after the start of baricitinib and continued for 24 weeks. We have decided to test the higher dose currently tested in another chronic inflammatory skin disorders called atopic dermatitis that showed in phase II and phase III significant efficacy with a good safety profile. Dosage schedule: 4 mg/day.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo of baricitinib associated with UVB TL01 phototherapy will be used. Placebo of baricitinib will be started 12 weeks before the start of phototherapy and will be continued for 36 weeks.

    Reporting group values
    		 Baricitinib Placebo Total
    Number of subjects
    		 37 12 49
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 32 11 43
        From 65-84 years
    		 5 1 6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 47.1 (36.9 to 52.6) 52.3 (42 to 60.8) -
    Gender categorical
    Units: Subjects
        Female
    		 28 7 35
        Male
    		 9 5 14
    Fitpatrick skin
    The Fitzpatrick skin type (or phototype) is a classification system that categorizes human skin based on its response to ultraviolet (UV) radiation, particularly in terms of tanning and burning. Type I: Very fair skin, often with red or blond hair and blue or green eyes. Always burns, never tans. Type II: Fair skin, usually with blue or green eyes. Burns easily, tans minimally. Type III: Medium skin tone. Sometimes burns, tans uniformly. Type IV: Olive or light brown skin. Burns minimally, tans easily. Type V: Brown skin. Rarely burns, tans darkly. Type VI: Dark brown or black skin. Nev
    Units: Subjects
        Type I
    		 0 0 0
        Type II
    		 6 3 9
        Type III
    		 22 7 29
        Type IV:
    		 2 0 2
        Type V:
    		 1 0 1
        Not recorded
    		 6 2 8
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects receiving the product and without any major protocol deviations (Per protocol)

    Subject analysis sets values
    		 Per protocol
    Number of subjects
    41
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    35
        From 65-84 years
    6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    21.4 ( to )
    Gender categorical
    Units: Subjects
        Female
    31
        Male
    10
    Fitpatrick skin
    The Fitzpatrick skin type (or phototype) is a classification system that categorizes human skin based on its response to ultraviolet (UV) radiation, particularly in terms of tanning and burning. Type I: Very fair skin, often with red or blond hair and blue or green eyes. Always burns, never tans. Type II: Fair skin, usually with blue or green eyes. Burns easily, tans minimally. Type III: Medium skin tone. Sometimes burns, tans uniformly. Type IV: Olive or light brown skin. Burns minimally, tans easily. Type V: Brown skin. Rarely burns, tans darkly. Type VI: Dark brown or black skin. Nev
    Units: Subjects
        Type I
    0
        Type II
    6
        Type III
    22
        Type IV:
    2
        Type V:
    1
        Not recorded
    0

    End points

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    End points reporting groups
    Reporting group title
    Baricitinib
    Reporting group description
    		 The treatment evaluated is baricitinib at a dosage of 4 mg/day for 36 weeks, combined with phototherapy twice a week started 12 weeks after the start of baricitinib and continued for 24 weeks. We have decided to test the higher dose currently tested in another chronic inflammatory skin disorders called atopic dermatitis that showed in phase II and phase III significant efficacy with a good safety profile. Dosage schedule: 4 mg/day.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo of baricitinib associated with UVB TL01 phototherapy will be used. Placebo of baricitinib will be started 12 weeks before the start of phototherapy and will be continued for 36 weeks.

    Subject analysis set title
    Per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects receiving the product and without any major protocol deviations (Per protocol)

    Primary: Mean percentage change in total Vitiligo Area Scoring Index (VASI) score from baseline to week 36

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    End point title
    		 Mean percentage change in total Vitiligo Area Scoring Index (VASI) score from baseline to week 36
    End point description
    The mean variation in percentage from baseline in VASI score after 36 weeks as well as its 95% unilateral confidence interval will be calculated in the patients of the experimental group (baricitinib + UVB TL01). This analysis will be performed per protocol, that is, only in patients who have correctly followed the study protocol, and on available data. No statistical comparison tests will be performed between the experimental group and the control group in this proof-of-concept phase 2 study.
    End point type
    Primary
    End point timeframe
    Baseline to week 36
    End point values
    		 Baricitinib Placebo Per protocol
    Number of subjects analysed
    31
    10
    31
    Units: %
        arithmetic mean (confidence interval 95%)
    49.1 (-47.7 to 91.1)
    10.1 (-115.9 to 68.1)
    49.1 (36.5 to 61.6)
    Statistical analysis title
    		 Mean decrease and IC of the mean decrease of T-VAS
    Statistical analysis description
    he hypothesis that this percentage is higher than 42.9% (repigmented surface threshold (as shown in Hamzavi I et al(11)) below which the treatment would be considered not efficacious enough will be tested by a one-sample Student's t test of an observed vs. a theoretical mean, at the 5% unilateral type I error.
    Comparison groups
    Baricitinib v Placebo
    Number of subjects included in analysis
    41
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.1619
    Method
    		 Student paired Test
    Parameter type
    		 Mean difference (net)
    Point estimate
    49.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.5
         upper limit
    		 61.6
    Variability estimate
    Standard deviation
    Dispersion value
    34.2
    Notes
    [1] - Omnibus analysis: All reporting groups, Selection of Reporting groups: BARICITINIB   

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    site personnel recorded any change in the condition(s) and any new conditions as AEs. Investigators should record their assessment of the potential relatedness of each AE to investigational product, via eCRF.
    Adverse event reporting additional description
    The investigator interpreted and documented whether or not an AE had a reasonable possibility of being related to study treatment, study device, or a study procedure, taking into account the disease, concomitant treatment, or pathologies.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Barcitinib
    Reporting group description
    		 -

    Reporting group title
    placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Barcitinib placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Barcitinib placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 37 (64.86%)
    7 / 12 (58.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    MALAISE
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    PYREXIA
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Weight increased
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    blood creatine phosphokinase increased
    Additional description: CPK Increase
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
    Additional description: Ankle sprain And Sprained ankle
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    Road traffic accident
    Additional description: Motor cycling accident
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Limb injury
    Additional description: open wound of finger(s)
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 37 (8.11%)
    1 / 12 (8.33%)
         occurrences all number
    4
    1
    Migraine
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Neuralgia
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    dry eye
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    APHTHOUS ULCER
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    CONSTIPATION
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    DIARRHOEA
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    DYSPEPSIA
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    SALIVARY GLAND CALCULUS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
    Additional description: Acneiform eruption
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Pruritus
    Additional description: Itching and itchy scalp
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Erythema
    Additional description: Erythema facial
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    ACARODERMATITIS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    BRONCHITIS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    5 / 37 (13.51%)
    3 / 12 (25.00%)
         occurrences all number
    7
    3
    HERPES SIMPLEX
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    HERPES VIRUS INFECTION
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    PAPILLOMA VIRAL INFECTION
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    RHINITIS
         subjects affected / exposed
    0 / 37 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    TONSILLITIS
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 37 (8.11%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    VARICELLA ZOSTER VIRUS INFECTION
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2021
    1. Addition of a label indicating the box number to which the baricitinib 4mg/placebo vial is associated (additional label on the primary packaging) by the coordinating pharmacy of Bordeaux University Hospital. 2. Addition of a label on the box (additional label on the secondary packaging) giving the box number, by the coordinating pharmacy at Bordeaux University Hospital. 3. Update of the paragraph on product dispatch and management (chapter 8.2.5) concerning the number of treatments sent to the centers.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39841460
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