Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

NCT04872101 | Completed Phase 3 Results

• 3 other identifiers: LP0133-14022020-002961-32U1111-1284-2145
• Study Type: interventional
• Target: 473
• Locations: 7 countries
• Sites: 50

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 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 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 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 (50)

LEO Investigational Site

Brussels, 1000, Belgium

Location

LEO Investigational Site

Edegem, 2650, Belgium

Location

LEO Investigational Site

Ghent, 9000, Belgium

Location

LEO Investigational Site

Kortrijk, 8500, Belgium

Location

LEO Investigational Site

Leuven, 3000, Belgium

Location

LEO Investigational Site

Loverval, 6280, Belgium

Location

LEO Investigational Site

Maldegem, 9990, Belgium

Location

LEO Investigational Site

Surrey, British Columbia, V3R 6A7, Canada

Location

LEO Investigational Site

Vancouver, British Columbia, V6H4E1, Canada

Location

LEO Investigational Site

Fredericton, New Brunswick, E3B 1G9, Canada

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LEO Investigational Site

Ajax, Ontario, L1S 7K8, Canada

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LEO Investigational Site

Cobourg, Ontario, K9A 4J9, Canada

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LEO Investigational Site

Etobicoke, Ontario, M8X 1Y9, Canada

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LEO Investigational Site

Hamilton, Ontario, L8S 1G5, Canada

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LEO Investigational Site

Toronto, Ontario, M2M 4J5, Canada

Location

LEO Investigational Site

Waterloo, Ontario, N2J 1C4, Canada

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LEO Investigational Site

Windsor, Ontario, N8W 1E6, Canada

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LEO Investigational Site

Aarhus, 8200, Denmark

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LEO Investigational Site

Copenhagen, 2400, Denmark

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LEO Investigational Site

Hellerup, 2900, Denmark

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LEO Investigational Site

Aachen, 52074, Germany

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LEO Investigational Site

Bad Bentheim, 48455, Germany

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LEO Investigational Site

Frankfurt, 60590, Germany

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LEO Investigational Site

Friedrichshafen, 88045, Germany

Location

LEO Invesitgational Site

Hanover, 30159, Germany

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LEO Investigational Site

Jena, 07743, Germany

Location

LEO Investigational Site

Lübeck, 23538, Germany

Location

LEO Investigational Site

Mahlow, 15831, Germany

Location

LEO Investigational Site

Münster, 48149, Germany

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LEO Investigational Site

Stuttgart, 70178, Germany

Location

LEO Investigational Site

Amsterdam, 1105 AZ, Netherlands

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LEO Investigational Site

Bergen op Zoom, 4614 VT, Netherlands

Location

LEO Investigational Site

Breda, 4818 CK, Netherlands

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LEO Investigational Site

Groningen, 9713 GZ, Netherlands

Location

LEO Investigational Site

Hoofddorp, 2134 TM, Netherlands

Location

LEO Investigational Site

Utrecht, 3584 CX, Netherlands

Location

LEO Investigational Site

Bialystok, 15-375, Poland

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LEO Investigational Site

Lublin, 20-406, Poland

Location

LEO Investigational Site

Rzeszów, 35-055, Poland

Location

LEO Investigational Site

Warsaw, 02-625, Poland

Location

LEO Investigational Site

Warsaw, 02-962, Poland

Location

LEO Investigational Site

Wroclaw, 50-566, Poland

Location

LEO Investigational Site

Wroclaw, 51-318, Poland

Location

LEO Investigational Site

Badalona, Barcelona, 08915, Spain

Location

LEO Investigational Site

Mieres, Principality of Asturias, 33611, Spain

Location

LEO Investigational Site

Bilbao, Vizcaya, 48013, Spain

Location

LEO Investigational Site

Alicante, 03010, Spain

Location

LEO Investigational Site

Barcelona, 08041, Spain

Location

LEO Investigational Site

Madrid, 28031, Spain

Location

LEO Investigational Site

Seville, 41009, Spain

Location

Related Publications (2)

• 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

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 25, 2021
• Primary Completion: December 27, 2022
• Study Completion: January 6, 2023
• Last Updated: April 8, 2025
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); NL (6); PL (7); ES (7); BE (7); DK (3); DE (10)