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

NCT ID: NCT05259722

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 513 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-12-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Delgocitinib cream 20 mg/g

Twice-daily topical application for up to 24 weeks

Group Type: EXPERIMENTAL

Delgocitinib

Intervention Type: DRUG

Cream for topical application 20 mg/g

Alitretinoin capsules 30 mg per capsule

1 capsule per day for up to 24 weeks

Group Type: ACTIVE_COMPARATOR

Toctino

Intervention Type: 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

Interventions

Delgocitinib

Cream for topical application 20 mg/g

Intervention Type: DRUG

Toctino

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days 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 of subject's own emollients) within 7 days prior to baseline.
• Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
• Treatment with any marketed biological therapy or investigational biologic agents:

• Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
• Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
• Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

LEO Pharma Investigational Site

Graz, , Austria

LEO Pharma Investigational Site

Linz, , Austria

LEO Pharma Investigational Site

Linz, , Austria

LEO Pharma Investigational Site

Calgary, , Canada

LEO Pharma Investigational Site

Calgary, , Canada

LEO Pharma Investigational Site

Edmonton, , Canada

LEO Pharma Investigational Site

Edmonton, , Canada

LEO Pharma Investigational Site

Guelph, , Canada

LEO Pharma Investigational Site

London, , Canada

LEO Pharma investigational site

London, , Canada

LEO Pharma investigational site

Markham, , Canada

LEO Pharma investigational site

Niagara Falls, , Canada

LEO Pharma Investigational Site

North York, , Canada

LEO Pharma investigational site

Québec, , Canada

LEO Pharma Investigational Site

Red Deer, , Canada

LEO Pharma investigational site

Sherbrooke, , Canada

LEO Pharma Investigational Site

Antony, , France

LEO Pharma Investigational Site

Martigues, , France

LEO Pharma Investigational Site

Montpellier, , France

LEO Pharma Investigational Site

Nice, , France

LEO Pharma investigational site

Nice, , France

LEO Pharma Investigational Site

Reims, , France

LEO Pharma Investigational Site

Toulon, , France

LEO Pharma Investigational Site

Augsburg, , Germany

LEO Pharma Investigational Site

Berlin, , Germany

LEO Pharma Investigational Site

Berlin, , Germany

LEO Pharma Investigational Site

Bochum, , Germany

LEO Pharma Investigational Site

Bochum, , Germany

LEO Pharma Investigational Site

Bonn, , Germany

LEO Pharma Investigational Site

Darmstadt, , Germany

LEO Pharma Investigational Site

Dresden, , Germany

LEO Pharma Investigational Site

Erlangen, , Germany

LEO Pharma Investigational Site

Essen, , Germany

LEO Pharma Investigational Site

Frankfurt, , Germany

LEO Pharma Investigational Site

Friedrichshafen, , Germany

LEO Pharma Investigational Site

Gera, , Germany

LEO Pharma Investigational Site

Göttingen, , Germany

LEO Pharma Investigational Site

Halle, , Germany

LEO Pharma Investigational Site

Hamburg, , Germany

LEO Pharma Investigational Site

Heidelberg, , Germany

LEO Pharma Investigational Site

Langenau, , Germany

LEO Pharma Investigational Site

Löhne, , Germany

LEO Pharma Investigational Site

Mainz, , Germany

LEO Pharma Investigational Site

Marburg, , Germany

LEO Pharma Investigational Site

Memmingen, , Germany

LEO Pharma Investigational Site

München, , Germany

LEO Pharma Investigational Site

München, , Germany

LEO Pharma Investigational Site

Oldenburg, , Germany

LEO Pharma Investigational Site

Osnabrück, , Germany

LEO Pharma Investigational Site

Wuppertal, , Germany

LEO Pharma Investigational Site

Bologna, , Italy

LEO Pharma Investigational Site

Brescia, , Italy

LEO Pharma Investigational Site

Catania, , Italy

LEO Pharma Investigational Site

Catanzaro, , Italy

LEO Pharma Investigational Site

Genova, , Italy

LEO Pharma Investigational Site

Lucca, , Italy

LEO Pharma Investigational Site

Milan, , Italy

LEO Pharma Investigational Site

Pavia, , Italy

LEO Pharma Investigational Site

Pisa, , Italy

LEO Pharma Investigational Site

Terracina, , Italy

LEO Pharma Investigational Site

Stavanger, , Norway

LEO Pharma Investigational Site

Tromsø, , Norway

LEO Pharma Investigational Site

Bialystok, , Poland

LEO Pharma investigational site

Bydgoszcz, , Poland

LEO Pharma Investigational Site

Chorzów, , Poland

LEO Pharma Investigational Site

Gdansk, , Poland

LEO Pharma Investigational Site

Gdynia, , Poland

LEO Pharma Investigational Site

Katowice, , Poland

LEO Pharma investigational site

Katowice, , Poland

LEO Pharma investigational site

Katowice, , Poland

LEO Pharma Investigational Site

Krakow, , Poland

LEO Pharma Investigational Site

Krakow, , Poland

LEO Pharma Investigational Site

Krakow, , Poland

LEO Pharma Investigational Site

Lodz, , Poland

LEO Pharma Investigational Site

Lublin, , Poland

LEO Pharma Investigational Site

Poznan, , Poland

LEO Pharma Investigational Site

Strzelce Opolskie, , Poland

LEO Pharma Investigational Site

Szczecin, , Poland

LEO Pharma Investigational Site

Warsaw, , Poland

LEO Pharma Investigational Site

Wroclaw, , Poland

LEO Pharma Investigational Site

Bratislava, , Slovakia

LEO Pharma Investigational Site

Svidník, , Slovakia

LEO Pharma Investigational Site

Trnava, , Slovakia

LEO Pharma Investigational Site

Alcalá de Henares, , Spain

LEO Pharma Investigational Site

Alicante, , Spain

LEO Pharma Investigational Site

Badalona, , Spain

LEO Pharma Investigational Site

Barcelona, , Spain

LEO Pharma Investigational Site

Barcelona, , Spain

LEO Pharma Investigational Site

Córdoba, , Spain

LEO Pharma Investigational Site

L'Hospitalet de Llobregat, , Spain

LEO Pharma Investigational Site

Madrid, , Spain

LEO Pharma Investigational Site

Madrid, , Spain

LEO Pharma Investigational Site

Madrid, , Spain

LEO Pharma Investigational Site

Madrid, , Spain

LEO Pharma investigational site

Málaga, , Spain

LEO Pharma investigational site

Pontevedra, , Spain

LEO Pharma Investigational Site

Seville, , Spain

LEO Pharma Investigational Site

Valencia, , Spain

LEO Pharma Investigational Site

Valencia, , Spain

LEO Pharma Investigational Site

Zaragoza, , Spain

LEO Pharma Investigational Site

London, , United Kingdom

LEO Pharma Investigational Site

Nottingham, , United Kingdom

Countries

Austria; Canada; France; Germany; Italy; Norway; Poland; Slovakia; Spain; United Kingdom

References

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.

Reference Type: RESULT

PMID: 40252681 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021-003543-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1284-2242

Identifier Type: OTHER

Identifier Source: secondary_id

LP0133-1528

Identifier Type: -

Identifier Source: org_study_id