Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

NCT04871711 | Completed Phase 3 Results

• 3 other identifiers: LP0133-14012020-002960-30U1111-1284-2099
• Study Type: interventional
• Target: 487
• Locations: 6 countries
• Sites: 54

Brief Summary

This was a 16-week study in adult participants with chronic hand eczema (CHE). \> The participants visited 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 was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With IGA-CHE TS at Week 16

  The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

  16 weeks

Secondary Outcomes (24)

• Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16

  16 weeks

• Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16

  16 weeks

• Number of Participants With IGA-CHE TS at Week 8

  8 weeks

• Number of Participants With IGA-CHE TS at Week 4

  4 weeks

• Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8

  8 weeks

Study Arms (2)

Delgocitinib cream 20 mg/g

EXPERIMENTAL

Twice-daily topical application for 16 weeks

Drug: Delgocitinib cream

Cream vehicle

PLACEBO COMPARATOR

Twice-daily topical application for 16 weeks

Drug: Cream vehicle

Interventions

Delgocitinib cream DRUG

Cream for topical application

Also known as: LEO 124249 cream

Delgocitinib cream 20 mg/g

Cream vehicle DRUG

The cream vehicle is similar to the delgocitinib cream\> except that it does not contain any active ingredient.

Cream vehicle

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 moderate to severe at screening and baseline according to Investigator's Global Assessment for chronic hand eczema (IGA-CHE) (i.e. an IGA-CHE score of 3 or 4).
• Hand Eczema Symptom Diary (HESD) itch score (weekly average) of ≥4 points at baseline.
• 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.

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.
• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (54)

LEO Investigational Site

Calgary, Alberta, T2J 7E1, Canada

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LEO Investigational Site

Calgary, Alberta, T3E 0B2, Canada

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LEO Investigational Site

Edmonton, Alberta, T5J 3S9, Canada

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LEO Investigational Site

Edmonton, Alberta, T6G 1C3, Canada

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LEO Investigational Site

Red Deer, Alberta, T4P-1K4, Canada

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LEO Investigational Site

Kingston, Ontario, K7L 2V7, Canada

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LEO Investigational Site

London, Ontario, N6A 3H7, Canada

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LEO Investigational Site

Markham, Ontario, L3P 1X3, Canada

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LEO Investigational Site

Toronto, Ontario, M3H 5Y8, Canada

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LEO Investigational Site

Montreal, Quebec, H2X 2V1, Canada

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LEO Investigational Site

Nice, Alpes-Maritimes, 06202, France

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LEO Investigational Site

Reims, Ardennes, 51100, France

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LEO Investigational Site

Nantes, Loire-Atlantique 6, 44093, France

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LEO Investigational Site

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

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LEO Investigational Site

Lille, Nord, 59000, France

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LEO Investigational Site

Le Mans, Sarthe, 72037, France

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LEO Investigational Site

Bordeaux, 33000, France

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LEO Investigational Site

Dijon, 21000, France

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LEO Investigational Site

Lorient, 56322, France

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LEO Investigational Site

Martigues, 13500, France

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LEO Investigational Site

Nice, 06000, France

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LEO Investigational Site

Paris, 75014, France

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LEO Investigational Site

Toulouse, 31000, France

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LEO Investigational Site

Berlin, 10117, Germany

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LEO Investigational Site

Dresden, 01307, Germany

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LEO Investigational Site

Gera, 07548, Germany

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LEO Investigational Site

Göttingen, 37073, Germany

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LEO Investigational Site

Hamburg, 22391, Germany

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LEO Investigational Site

Haßfurt, 97437, Germany

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LEO Investigational Site

Mainz, 55128, Germany

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LEO Investigational Site

Memmingen, 87700, Germany

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LEO Investigational Site

München, 80802, Germany

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LEO Investigational Site

Osnabrück, 49074, Germany

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LEO Investigational Site

Brescia, 25123, Italy

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LEO Investigational Site

L’Aquila, 67100, Italy

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LEO Investigational Site

Milan, 20122, Italy

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LEO Investigational Site

Perugia, 06134, Italy

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LEO Investigational Site

Roma, 00168, Italy

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LEO Investigational Site

Vicenza, 36100, Italy

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LEO Investigational Site

Bialystok, 15-794, Poland

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LEO Investigational Site

Gdansk, 80-546, Poland

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LEO Investigational Site

Krakow, 30-033, Poland

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LEO Investigational Site

Krakow, 31-011, Poland

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LEO Investigational Site

Lodz, 90-436, Poland

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LEO Investigational Site

Lublin, 20-081, Poland

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LEO Investigational Site

Osielsko, 86-031, Poland

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LEO Investigational Site

Warsaw, 02-507, Poland

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LEO Investigational Site

Warsaw, 02-953, Poland

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LEO Investigational Site

Salford, Greater Manchester, M6 8HD, United Kingdom

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LEO Investigational Site

Leicester, Leicestershire, LE1 5WW, United Kingdom

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LEO Investigational Site

London, Leytonstone, E11 1NR, United Kingdom

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LEO Investigational Site

Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

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LEO Investigational Site

Redhill, Surrey, RH1 5RH, United Kingdom

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LEO Investigational Site

London, SE1 9RT, United Kingdom

Location

Related Publications (4)

• Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18.

  PMID: 39033766 RESULT

• Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2025 Nov 15. doi: 10.1007/s13555-025-01592-y. Online ahead of print.

  PMID: 41240207 DERIVED

• Silverberg JI, Agner T, Baranowski K, Plohberger U, Thoning H, Arbuckle R, Grant L, Skingley G, Bissonnette R. Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity. Arch Dermatol Res. 2024 Mar 20;316(4):110. doi: 10.1007/s00403-024-02818-3.

  PMID: 38507100 DERIVED

• Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.

  PMID: 38485862 DERIVED

Results Point of Contact

• Title: Disclosure Specialist
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 44945888

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: May 10, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 8, 2025
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6); DE (10); FR (13); PL (9); CA (10); GB (6)