A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

Last updated: May 1, 2025
Sponsor: LEO Pharma
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Allergy

Atopic Dermatitis

Treatment

Delgocitinib

Toctino

Clinical Study ID

NCT05259722
LP0133-1528
2021-003543-16
U1111-1284-2242
  • Ages > 18
  • All Genders

Study Summary

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

Eligibility Criteria

Inclusion

Main inclusion criteria:

  • Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 monthsor returned twice or more within the last 12 months.

  • Disease severity graded as severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4).

  • Participants who have a documented recent history of inadequate response totreatment with topical corticosteroids (TCS) or for whom TCS are documented to beotherwise medically inadvisable (e.g. due to important side effects or safetyrisks).

  • Participants adherent to standard non-medicated skin care including avoidance ofknown and relevant irritants and allergens.

  • Participants must use contraceptive methods in accordance with local regulationsregarding the methods of contraception for those participating in clinical studies

Exclusion

Main exclusion criteria:

  • Concurrent skin diseases on the hands, e.g. tinea manuum.

  • Active atopic dermatitis requiring medical treatment in regions other than the handsand feet.

  • Active psoriasis on any part of the body.

  • Hyperkeratotic hand eczema in combination with a history of psoriasis on any part ofthe body.

  • Clinically significant infection on the hands.

  • Participants who cannot receive alitretinoin.

  • Clinically significant infection within 28 days prior to baseline which, in theopinion of the investigator, may compromise the safety of the participant in thetrial, interfere with evaluation of the IMP, or reduce the participant's ability toparticipate in the trial.

  • History of any known primary immunodeficiency disorder including a positive humanimmunodeficiency virus (HIV) test at screening, or the participant takingantiretroviral medications as determined by medical history and/or participant'sverbal report.

  • Any disorder which is not stable and could:

  • Affect the safety of the participant throughout the trial.

  • Impede the participant's ability to complete the trial.

  • Positive hepatitis B surface antigen or hepatitis C virus antibody serology atscreening.

  • Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids,or corticosteroids within 28 days prior to baseline.

  • Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days priorto baseline.

  • Previous or current treatment with Janus kinase (JAK) inhibitors (includingdelgocitinib/LEO 124249), systemic or topical.

  • Cutaneously applied treatment with immunomodulators or TCS on the hands within 14days prior to baseline.

  • Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.

  • Other transdermal or cutaneously applied therapy on the hands (except for the use ofsubject's own emollients) within 7 days prior to baseline.

  • Cutaneously applied treatments in regions other than the hands, which couldinterfere with clinical trial evaluations or pose a safety concern within 7 daysprior to baseline.

  • Treatment with any marketed biological therapy or investigational biologic agents:

  • Any cell-depleting agents: within 6 months prior to baseline, or untillymphocyte count returns to normal, whichever is longer.

  • Other biologics: within 3 months or 5 half-lives, whichever is longer, prior tobaseline.

  • Previously used alitretinoin or participated in a clinical trial with alitretinoinor delgocitinib.

Study Design

Total Participants: 513
Treatment Group(s): 2
Primary Treatment: Delgocitinib
Phase: 3
Study Start date:
June 15, 2022
Estimated Completion Date:
December 05, 2023

Connect with a study center

  • LEO Pharma Investigational Site

    Graz, 8036
    Austria

    Site Not Available

  • LEO Pharma Investigational Site

    Linz, 4021
    Austria

    Site Not Available

  • LEO Pharma investigational site

    Wien, 1200
    Austria

    Site Not Available

  • LEO Pharma Investigational Site

    Calgary, T2W 4X9
    Canada

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  • LEO Pharma Investigational Site

    Edmonton, T6G 1C3
    Canada

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  • LEO Pharma Investigational Site

    Guelph, N1L 0B7
    Canada

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  • LEO Pharma Investigational Site

    London, N6A 2C2
    Canada

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  • LEO Pharma investigational site

    London, N6A 5R9
    Canada

    Site Not Available

  • LEO Pharma investigational site

    Markham, L3P 1X3
    Canada

    Site Not Available

  • LEO Pharma investigational site

    Niagara Falls, L2H 1H5
    Canada

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  • LEO Pharma Investigational Site

    North York, M2N 3A6
    Canada

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    Québec, G1W 4R4
    Canada

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    Red Deer, T4P 1K4
    Canada

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    Sherbrooke, J1G 1X9
    Canada

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    Toronto, M9W 4L6
    Canada

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    Vancouver, V5Z 4E8
    Canada

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    Antony, 92160
    France

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    Martigues, 13500
    France

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    Montpellier, 34295
    France

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    Nice, 06000
    France

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    Nice, 6202
    France

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    Pierre-Bénite, 69495
    France

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    Reims, 51100
    France

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    Rennes Cedex 9, 35033
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    Toulon, 83000
    France

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    Augsburg, 86163
    Germany

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    Berlin, 10789
    Germany

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    Bochum, 44793
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    Bonn, 53111
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    Darmstadt, 64283
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    Dresden, 01307
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    Erlangen, 91054
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    Essen, 45147
    Germany

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    Frankfurt, 60590
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    Friedrichshafen, 88045
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    Gera, 07548
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    Göttingen, 37075
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    Halle, 06110
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    Ibbenbüren, 49477
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    Kiel, 24105
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    Langenau, 89129
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    Lohne, 49393
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    Lohne, 49393
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    Mainz, 55131
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    Marburg, 35043
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    Memmingen, 87700
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    Osnabrück, 49074
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    Catania, 95123
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    Catanzaro, 88100
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    Genova, 16132
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    Lucca, 55100
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    Milano, 20089
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    Napoli, 80131
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    Pisa, 56126
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    Terracina, 4019
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    Bodø, 8005
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    Stavanger, 4011
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    Tromsø, 9038
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    Białystok, 15-794
    Poland

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    Chorzów, 41-500
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    Gdańsk, 80-546
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    Gdynia, 81-338
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    Katowice, 40-081
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    Kraków, 30-727
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    Lublin, 20-080
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    Strzelce Opolskie, 47-100
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    Active - Recruiting

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    Łódź, 90-436
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    Bratislava, 851 01
    Slovakia

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    Svidník, 089 01
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    Tmava, 91775
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    Alcalá de Henares, 28805
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    Alicante, 03010
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    Badalona, 08916
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    Barcelona, 08003
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    Córdoba, 14004
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    Hospitalet de Llobregat, 08907
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    Madrid, 28040
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    Málaga, 29009
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    Pontevedra, 36071
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    Sevilla, 41009
    Spain

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    Valencia, 46014
    Spain

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    Zaragoza, 50009
    Spain

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    Bristol, BS2 8HW
    United Kingdom

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    London, SE1 9RT
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    Nottingham, NG7 2UH
    United Kingdom

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