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

NCT05259722 | Completed Phase 3 Results

• 3 other identifiers: LP0133-15282021-003543-16U1111-1284-2242
• Study Type: interventional
• Target: 513
• Locations: 10 countries
• Sites: 102

Brief 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.

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• Change in HECSI Score From Baseline to Week 12

  The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.

  12 weeks

Secondary Outcomes (10)

• HECSI-90 at Week 12

  12 weeks

• IGA-CHE TS at Week 12.

  12 weeks

• Change in HESD Itch Score (Weekly Average) From Baseline to Week 12

  12 weeks

• Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.

  12 weeks

• AUC of HECSI-90 From Baseline up to Week 24

  24 weeks

Study Arms (2)

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Twice-daily topical application for up to 24 weeks

Drug: Delgocitinib

Alitretinoin capsules 30 mg per capsule

ACTIVE COMPARATOR

1 capsule per day for up to 24 weeks

Drug: Toctino

Interventions

Delgocitinib DRUG

Cream for topical application 20 mg/g

Delgocitinib cream 20 mg/g

Toctino DRUG

1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

Alitretinoin capsules 30 mg per capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or 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 to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
• Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
• Participants must use contraceptive methods in accordance with local regulations regarding the methods of contraception for those participating in clinical studies

You may not qualify if:

• Concurrent skin diseases on the hands, e.g. tinea manuum.
• Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
• Active psoriasis on any part of the body.
• Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
• Clinically significant infection on the hands.
• Participants who cannot receive alitretinoin.
• Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal 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 at screening.
• 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 prior to baseline.
• Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (102)

LEO Pharma Investigational Site

Graz, 8036, Austria

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LEO Pharma Investigational Site

Linz, 4010, Austria

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LEO Pharma Investigational Site

Linz, 4021, Austria

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LEO Pharma Investigational Site

Calgary, T2J 7E1, Canada

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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

Edmonton, T6W0J5, 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

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LEO Pharma investigational site

Markham, L3P 1X3, Canada

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Niagara Falls, L2H 1H5, Canada

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North York, M2N 3A6, Canada

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Québec, G1W 4R4, Canada

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LEO Pharma Investigational Site

Red Deer, T4P 1K4, Canada

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LEO Pharma investigational site

Sherbrooke, J1G 1X9, Canada

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LEO Pharma Investigational Site

Antony, 92160, France

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LEO Pharma Investigational Site

Martigues, 13500, France

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LEO Pharma Investigational Site

Montpellier, 34295, France

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LEO Pharma Investigational Site

Nice, 06000, France

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LEO Pharma investigational site

Nice, 6202, France

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LEO Pharma Investigational Site

Reims, 51100, France

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LEO Pharma Investigational Site

Toulon, 83000, France

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LEO Pharma Investigational Site

Augsburg, 86163, Germany

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LEO Pharma Investigational Site

Berlin, 10789, Germany

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LEO Pharma Investigational Site

Berlin, 13055, Germany

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LEO Pharma Investigational Site

Bochum, 44791, Germany

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LEO Pharma Investigational Site

Bochum, 44793, Germany

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LEO Pharma Investigational Site

Bonn, 53111, Germany

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LEO Pharma Investigational Site

Darmstadt, 64283, Germany

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LEO Pharma Investigational Site

Dresden, 01307, Germany

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LEO Pharma Investigational Site

Erlangen, 91054, Germany

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LEO Pharma Investigational Site

Essen, 45147, Germany

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LEO Pharma Investigational Site

Frankfurt, 60590, Germany

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LEO Pharma Investigational Site

Friedrichshafen, 88045, Germany

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LEO Pharma Investigational Site

Gera, 07548, Germany

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LEO Pharma Investigational Site

Göttingen, 37075, Germany

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LEO Pharma Investigational Site

Halle, 06110, Germany

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LEO Pharma Investigational Site

Hamburg, 22391, Germany

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LEO Pharma Investigational Site

Heidelberg, 69120, Germany

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LEO Pharma Investigational Site

Langenau, 89129, Germany

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LEO Pharma Investigational Site

Löhne, 49393, Germany

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LEO Pharma Investigational Site

Mainz, 55131, Germany

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LEO Pharma Investigational Site

Marburg, 35043, Germany

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LEO Pharma Investigational Site

Memmingen, 87700, Germany

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LEO Pharma Investigational Site

München, 80337, Germany

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LEO Pharma Investigational Site

München, 80802, Germany

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LEO Pharma Investigational Site

Oldenburg, 26133, Germany

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LEO Pharma Investigational Site

Osnabrück, 49074, Germany

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LEO Pharma Investigational Site

Wuppertal, 42287, Germany

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LEO Pharma Investigational Site

Bologna, 40138, Italy

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LEO Pharma Investigational Site

Brescia, 25123, Italy

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LEO Pharma Investigational Site

Catania, 95123, Italy

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LEO Pharma Investigational Site

Catanzaro, 88100, Italy

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LEO Pharma Investigational Site

Genova, 16132, Italy

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LEO Pharma Investigational Site

Lucca, 55100, Italy

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LEO Pharma Investigational Site

Milan, 20089, Italy

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LEO Pharma Investigational Site

Pavia, 27100, Italy

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LEO Pharma Investigational Site

Pisa, 56126, Italy

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LEO Pharma Investigational Site

Terracina, 4019, Italy

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LEO Pharma Investigational Site

Stavanger, 4011, Norway

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LEO Pharma Investigational Site

Tromsø, 9038, Norway

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LEO Pharma Investigational Site

Bialystok, 15-794, Poland

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LEO Pharma investigational site

Bydgoszcz, 85-796, Poland

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LEO Pharma Investigational Site

Chorzów, 41-500, Poland

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LEO Pharma Investigational Site

Gdansk, 80-546, Poland

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LEO Pharma Investigational Site

Gdynia, 81-338, Poland

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LEO Pharma Investigational Site

Katowice, 40-081, Poland

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LEO Pharma investigational site

Katowice, 40-611, Poland

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Katowice, 40-851, Poland

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LEO Pharma Investigational Site

Krakow, 30-033, Poland

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LEO Pharma Investigational Site

Krakow, 30-727, Poland

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Krakow, 31-501, Poland

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LEO Pharma Investigational Site

Lodz, 90-436, Poland

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LEO Pharma Investigational Site

Lublin, 20-080, Poland

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Poznan, 61-731, Poland

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LEO Pharma Investigational Site

Strzelce Opolskie, 47-100, Poland

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LEO Pharma Investigational Site

Szczecin, 71-434, Poland

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LEO Pharma Investigational Site

Warsaw, 02-677, Poland

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LEO Pharma Investigational Site

Wroclaw, 51-685, Poland

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LEO Pharma Investigational Site

Bratislava, 851 01, Slovakia

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LEO Pharma Investigational Site

Svidník, 089 01, Slovakia

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LEO Pharma Investigational Site

Trnava, 917 75, Slovakia

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LEO Pharma Investigational Site

Alcalá de Henares, 28805, Spain

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LEO Pharma Investigational Site

Alicante, 03010, Spain

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LEO Pharma Investigational Site

Badalona, 08916, Spain

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LEO Pharma Investigational Site

Barcelona, 08003, Spain

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LEO Pharma Investigational Site

Barcelona, 08025, Spain

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LEO Pharma Investigational Site

Córdoba, 14004, Spain

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LEO Pharma Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

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LEO Pharma Investigational Site

Madrid, 28006, Spain

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LEO Pharma Investigational Site

Madrid, 28034, Spain

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LEO Pharma Investigational Site

Madrid, 28040, Spain

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LEO Pharma Investigational Site

Madrid, 28041, Spain

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LEO Pharma investigational site

Málaga, 29009, Spain

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LEO Pharma investigational site

Pontevedra, 36071, Spain

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LEO Pharma Investigational Site

Seville, 41009, Spain

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LEO Pharma Investigational Site

Valencia, 46014, Spain

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LEO Pharma Investigational Site

Valencia, 46026, Spain

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LEO Pharma Investigational Site

Zaragoza, 50009, Spain

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LEO Pharma Investigational Site

London, SE1 9RT, United Kingdom

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LEO Pharma Investigational Site

Nottingham, NG7 2UH, United Kingdom

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Related Publications (1)

• Gimenez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Osterdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 May 10;405(10490):1676-1688. doi: 10.1016/S0140-6736(25)00001-7. Epub 2025 Apr 16.

  PMID: 40252681 RESULT

MeSH Terms

Interventions

delgocitinib; Alitretinoin

Intervention Hierarchy (Ancestors)

Tretinoin; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Clinical Disclosure
• Organization: LEO Pharma

disclosure@leo-pharma.com

+4544945888

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: February 28, 2022
• Study Start: June 15, 2022
• Primary Completion: November 8, 2023
• Study Completion: December 5, 2023
• Last Updated: May 9, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17); CA (13); AU (3); DE (27); NO (2); PL (18); FR (7); SL (3); IT (10); GB (2)