Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
NCT ID: NCT04871711
Last Updated: 2025-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
487 participants
INTERVENTIONAL
2021-05-10
2022-10-31
Brief Summary
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\> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Delgocitinib cream 20 mg/g
Twice-daily topical application for 16 weeks
Delgocitinib cream
Cream for topical application
Cream vehicle
Twice-daily topical application for 16 weeks
Cream vehicle
The cream vehicle is similar to the delgocitinib cream\> except that it does not contain any active ingredient.
Interventions
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Delgocitinib cream
Cream for topical application
Cream vehicle
The cream vehicle is similar to the delgocitinib cream\> except that it does not contain any active ingredient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Calgary, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
LEO Investigational Site
Edmonton, Alberta, Canada
LEO Investigational Site
Red Deer, Alberta, Canada
LEO Investigational Site
Kingston, Ontario, Canada
LEO Investigational Site
London, Ontario, Canada
LEO Investigational Site
Markham, Ontario, Canada
LEO Investigational Site
Toronto, Ontario, Canada
LEO Investigational Site
Montreal, Quebec, Canada
LEO Investigational Site
Nice, Alpes-Maritimes, France
LEO Investigational Site
Reims, Ardennes, France
LEO Investigational Site
Nantes, Loire-Atlantique 6, France
LEO Investigational Site
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
LEO Investigational Site
Lille, Nord, France
LEO Investigational Site
Le Mans, Sarthe, France
LEO Investigational Site
Bordeaux, , France
LEO Investigational Site
Dijon, , France
LEO Investigational Site
Lorient, , France
LEO Investigational Site
Martigues, , France
LEO Investigational Site
Nice, , France
LEO Investigational Site
Paris, , France
LEO Investigational Site
Toulouse, , France
LEO Investigational Site
Berlin, , Germany
LEO Investigational Site
Dresden, , Germany
LEO Investigational Site
Gera, , Germany
LEO Investigational Site
Göttingen, , Germany
LEO Investigational Site
Hamburg, , Germany
LEO Investigational Site
Haßfurt, , Germany
LEO Investigational Site
Mainz, , Germany
LEO Investigational Site
Memmingen, , Germany
LEO Investigational Site
München, , Germany
LEO Investigational Site
Osnabrück, , Germany
LEO Investigational Site
Brescia, , Italy
LEO Investigational Site
L’Aquila, , Italy
LEO Investigational Site
Milan, , Italy
LEO Investigational Site
Perugia, , Italy
LEO Investigational Site
Roma, , Italy
LEO Investigational Site
Vicenza, , Italy
LEO Investigational Site
Bialystok, , Poland
LEO Investigational Site
Gdansk, , Poland
LEO Investigational Site
Krakow, , Poland
LEO Investigational Site
Krakow, , Poland
LEO Investigational Site
Lodz, , Poland
LEO Investigational Site
Lublin, , Poland
LEO Investigational Site
Osielsko, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Warsaw, , Poland
LEO Investigational Site
Salford, Greater Manchester, United Kingdom
LEO Investigational Site
Leicester, Leicestershire, United Kingdom
LEO Investigational Site
London, Leytonstone, United Kingdom
LEO Investigational Site
Middlesbrough, North Yorkshire, United Kingdom
LEO Investigational Site
Redhill, Surrey, United Kingdom
LEO Investigational Site
London, , United Kingdom
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-002960-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1284-2099
Identifier Type: OTHER
Identifier Source: secondary_id
LP0133-1401
Identifier Type: -
Identifier Source: org_study_id
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