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

NCT ID: NCT04872101

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2023-01-06

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

Study Design

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

Study Groups

Delgocitinib cream 20 mg/g

Twice-daily topical application for 16 weeks

Group Type: EXPERIMENTAL

Delgocitinib cream

Intervention Type: DRUG

Cream for topical application

Cream vehicle

Twice-daily topical application for 16 weeks

Group Type: PLACEBO_COMPARATOR

Cream vehicle

Intervention Type: DRUG

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

Interventions

Delgocitinib cream

Cream for topical application

Intervention Type: DRUG

Cream vehicle

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

Intervention Type: DRUG

Other Intervention Names

LEO 124249 cream

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 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.

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.
• 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.
• 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.

• 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 Investigational Site

Brussels, , Belgium

LEO Investigational Site

Edegem, , Belgium

LEO Investigational Site

Ghent, , Belgium

LEO Investigational Site

Kortrijk, , Belgium

LEO Investigational Site

Leuven, , Belgium

LEO Investigational Site

Loverval, , Belgium

LEO Investigational Site

Maldegem, , Belgium

LEO Investigational Site

Surrey, British Columbia, Canada

LEO Investigational Site

Vancouver, British Columbia, Canada

LEO Investigational Site

Fredericton, New Brunswick, Canada

LEO Investigational Site

Ajax, Ontario, Canada

LEO Investigational Site

Cobourg, Ontario, Canada

LEO Investigational Site

Etobicoke, Ontario, Canada

LEO Investigational Site

Hamilton, Ontario, Canada

LEO Investigational Site

Toronto, Ontario, Canada

LEO Investigational Site

Waterloo, Ontario, Canada

LEO Investigational Site

Windsor, Ontario, Canada

LEO Investigational Site

Aarhus, , Denmark

LEO Investigational Site

Copenhagen, , Denmark

LEO Investigational Site

Hellerup, , Denmark

LEO Investigational Site

Aachen, , Germany

LEO Investigational Site

Bad Bentheim, , Germany

LEO Investigational Site

Frankfurt, , Germany

LEO Investigational Site

Friedrichshafen, , Germany

LEO Invesitgational Site

Hanover, , Germany

LEO Investigational Site

Jena, , Germany

LEO Investigational Site

Lübeck, , Germany

LEO Investigational Site

Mahlow, , Germany

LEO Investigational Site

Münster, , Germany

LEO Investigational Site

Stuttgart, , Germany

LEO Investigational Site

Amsterdam, , Netherlands

LEO Investigational Site

Bergen op Zoom, , Netherlands

LEO Investigational Site

Breda, , Netherlands

LEO Investigational Site

Groningen, , Netherlands

LEO Investigational Site

Hoofddorp, , Netherlands

LEO Investigational Site

Utrecht, , Netherlands

LEO Investigational Site

Bialystok, , Poland

LEO Investigational Site

Lublin, , Poland

LEO Investigational Site

Rzeszów, , Poland

LEO Investigational Site

Warsaw, , Poland

LEO Investigational Site

Warsaw, , Poland

LEO Investigational Site

Wroclaw, , Poland

LEO Investigational Site

Wroclaw, , Poland

LEO Investigational Site

Badalona, Barcelona, Spain

LEO Investigational Site

Mieres, Principality of Asturias, Spain

LEO Investigational Site

Bilbao, Vizcaya, Spain

LEO Investigational Site

Alicante, , Spain

LEO Investigational Site

Barcelona, , Spain

LEO Investigational Site

Madrid, , Spain

LEO Investigational Site

Seville, , Spain

Countries

Belgium; Canada; Denmark; Germany; Netherlands; Poland; Spain

References

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.

Reference Type: RESULT

PMID: 39033766 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-002961-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1284-2145

Identifier Type: OTHER

Identifier Source: secondary_id

LP0133-1402

Identifier Type: -

Identifier Source: org_study_id