- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05259722
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
A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Clinical Disclosure
- Phone Number: (+1) 877-557-1168
- Email: clinicaltrialscontactus@leo-pharma.com
Study Locations
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Graz, Austria, 8036
- LEO Pharma Investigational Site
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Linz, Austria, 4021
- LEO Pharma Investigational Site
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Linz, Austria, 4010
- LEO Pharma Investigational Site
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Calgary, Canada, T2J 7E1
- LEO Pharma Investigational Site
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Calgary, Canada, T2W 4X9
- LEO Pharma Investigational Site
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Edmonton, Canada, T6G 1C3
- LEO Pharma Investigational Site
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Edmonton, Canada, T6W0J5
- LEO Pharma Investigational Site
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Guelph, Canada, N1L 0B7
- LEO Pharma Investigational Site
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London, Canada, N6A 2C2
- LEO Pharma Investigational Site
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London, Canada, N6A 5R9
- LEO Pharma Investigational Site
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Markham, Canada, L3P 1X3
- LEO Pharma Investigational Site
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Niagara Falls, Canada, L2H 1H5
- LEO Pharma Investigational Site
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North York, Canada, M2N 3A6
- LEO Pharma Investigational Site
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Québec, Canada, G1W 4R4
- LEO Pharma Investigational Site
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Red Deer, Canada, T4P 1K4
- LEO Pharma Investigational Site
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Sherbrooke, Canada, J1G 1X9
- LEO Pharma Investigational Site
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Antony, France, 92160
- LEO Pharma Investigational Site
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Martigues, France, 13500
- LEO Pharma Investigational Site
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Montpellier, France, 34295
- LEO Pharma Investigational Site
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Nice, France, 06000
- LEO Pharma Investigational Site
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Nice, France, 6202
- LEO Pharma Investigational Site
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Reims, France, 51100
- LEO Pharma Investigational Site
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Toulon, France, 83000
- LEO Pharma Investigational Site
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Augsburg, Germany, 86163
- LEO Pharma Investigational Site
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Berlin, Germany, 10789
- LEO Pharma Investigational Site
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Berlin, Germany, 13055
- LEO Pharma Investigational Site
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Bochum, Germany, 44791
- LEO Pharma Investigational Site
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Bochum, Germany, 44793
- LEO Pharma Investigational Site
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Bonn, Germany, 53111
- LEO Pharma Investigational Site
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Darmstadt, Germany, 64283
- LEO Pharma Investigational Site
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Dresden, Germany, 01307
- LEO Pharma Investigational Site
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Erlangen, Germany, 91054
- LEO Pharma Investigational Site
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Essen, Germany, 45147
- LEO Pharma Investigational Site
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Frankfurt, Germany, 60590
- LEO Pharma Investigational Site
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Friedrichshafen, Germany, 88045
- LEO Pharma Investigational Site
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Gera, Germany, 07548
- LEO Pharma Investigational Site
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Göttingen, Germany, 37075
- LEO Pharma Investigational Site
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Halle, Germany, 06110
- LEO Pharma Investigational Site
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Hamburg, Germany, 22391
- LEO Pharma Investigational Site
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Heidelberg, Germany, 69120
- LEO Pharma Investigational Site
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Langenau, Germany, 89129
- LEO Pharma Investigational Site
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Lohne, Germany, 49393
- LEO Pharma Investigational Site
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Mainz, Germany, 55131
- LEO Pharma Investigational Site
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Marburg, Germany, 35043
- LEO Pharma Investigational Site
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Memmingen, Germany, 87700
- LEO Pharma Investigational Site
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München, Germany, 80337
- LEO Pharma Investigational Site
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München, Germany, 80802
- LEO Pharma Investigational Site
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Oldenburg, Germany, 26133
- LEO Pharma Investigational Site
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Osnabrück, Germany, 49074
- LEO Pharma Investigational Site
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Wuppertal, Germany, 42287
- LEO Pharma Investigational Site
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Bologna, Italy, 40138
- LEO Pharma Investigational Site
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Brescia, Italy, 25123
- LEO Pharma Investigational Site
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Catania, Italy, 95123
- LEO Pharma Investigational Site
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Catanzaro, Italy, 88100
- LEO Pharma Investigational Site
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Genova, Italy, 16132
- LEO Pharma Investigational Site
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Lucca, Italy, 55100
- LEO Pharma Investigational Site
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Milano, Italy, 20089
- LEO Pharma Investigational Site
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Pavia, Italy, 27100
- LEO Pharma Investigational Site
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Pisa, Italy, 56126
- LEO Pharma Investigational Site
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Terracina, Italy, 4019
- LEO Pharma Investigational Site
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Stavanger, Norway, 4011
- LEO Pharma Investigational Site
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Tromsø, Norway, 9038
- LEO Pharma Investigational Site
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Białystok, Poland, 15-794
- LEO Pharma Investigational Site
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Bydgoszcz, Poland, 85-796
- LEO Pharma Investigational Site
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Chorzów, Poland, 41-500
- LEO Pharma Investigational Site
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Gdańsk, Poland, 80-546
- LEO Pharma Investigational Site
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Gdynia, Poland, 81-338
- LEO Pharma Investigational Site
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Katowice, Poland, 40-081
- LEO Pharma Investigational Site
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Katowice, Poland, 40-611
- LEO Pharma Investigational Site
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Katowice, Poland, 40-851
- LEO Pharma Investigational Site
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Kraków, Poland, 30-033
- LEO Pharma Investigational Site
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Kraków, Poland, 31-501
- LEO Pharma Investigational Site
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Kraków, Poland, 30-727
- LEO Pharma Investigational Site
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Lublin, Poland, 20-080
- LEO Pharma Investigational Site
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Poznań, Poland, 61-731
- LEO Pharma Investigational Site
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Strzelce Opolskie, Poland, 47-100
- LEO Pharma Investigational Site
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Szczecin, Poland, 71-434
- LEO Pharma Investigational Site
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Warszawa, Poland, 02-677
- LEO Pharma Investigational Site
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Wrocław, Poland, 51-685
- LEO Pharma Investigational Site
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Łódź, Poland, 90-436
- LEO Pharma Investigational Site
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Bratislava, Slovakia, 851 01
- LEO Pharma Investigational Site
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Svidník, Slovakia, 089 01
- LEO Pharma Investigational Site
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Trnava, Slovakia, 917 75
- LEO Pharma Investigational Site
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Alcalá de Henares, Spain, 28805
- LEO Pharma Investigational Site
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Alicante, Spain, 03010
- LEO Pharma Investigational Site
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Badalona, Spain, 08916
- LEO Pharma Investigational Site
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Barcelona, Spain, 08003
- LEO Pharma Investigational Site
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Barcelona, Spain, 08025
- LEO Pharma Investigational Site
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Córdoba, Spain, 14004
- LEO Pharma Investigational Site
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Hospitalet de Llobregat, Spain, 08907
- LEO Pharma Investigational Site
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Madrid, Spain, 28006
- LEO Pharma Investigational Site
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Madrid, Spain, 28041
- LEO Pharma Investigational Site
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Madrid, Spain, 28034
- LEO Pharma Investigational Site
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Madrid, Spain, 28040
- LEO Pharma Investigational Site
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Málaga, Spain, 29009
- LEO Pharma Investigational Site
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Pontevedra, Spain, 36071
- LEO Pharma Investigational Site
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Sevilla, Spain, 41009
- LEO Pharma Investigational Site
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Valencia, Spain, 46014
- LEO Pharma Investigational Site
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Valencia, Spain, 46026
- LEO Pharma Investigational Site
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Zaragoza, Spain, 50009
- LEO Pharma Investigational Site
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London, United Kingdom, SE1 9RT
- LEO Pharma Investigational Site
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Nottingham, United Kingdom, NG7 2UH
- LEO Pharma Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Main 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
Main 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Delgocitinib cream 20 mg/g
Twice-daily topical application for up to 24 weeks
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Cream for topical application 20 mg/g
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Active Comparator: Alitretinoin capsules 30 mg per capsule
1 capsule per day for up to 24 weeks
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1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HECSI score from baseline to Week 12
Time Frame: 12 weeks
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The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HECSI-90 at Week 12
Time Frame: 12 weeks
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The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
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12 weeks
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IGA-CHE TS at Week 12.
Time Frame: 12 weeks
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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.
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12 weeks
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Change in HESD itch score (weekly average) from baseline to Week 12
Time Frame: 12 weeks
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The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis.
This endpoint will only assess the 'itch' component.
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12 weeks
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Change in HESD pain score (weekly average) from baseline to Week 12.
Time Frame: 12 weeks
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The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis.
This endpoint will only assess the 'pain' component.
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12 weeks
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AUC of HECSI-90 from baseline up to Week 24
Time Frame: 24 weeks
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The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
The area under the curve (AUC) at participant level will be determined as follows: 1 will be assigned when response is observed and 0 otherwise.
The AUC is interpreted as number of days with 90% reduction in HECSI score until Week 24.
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24 weeks
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AUC of change from baseline in DLQI score up to Week 24
Time Frame: 24 weeks
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The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week.
The DLQI score is the sum of the 10 items (score ranging from 0 to 30).
The area under the curve (AUC) at patient level will be determined from the change from baseline in DLQI score estimated piecewise from Week 0 to Week 24.
Differences will be analysed with opposite sign to interpret positive area as improvement in scores and negative area as worsening.
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24 weeks
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Change in HECSI score from baseline to Week 24
Time Frame: 24 weeks
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The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.
The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
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24 weeks
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Number of treatment-emergent AEs from baseline up to Week 26
Time Frame: 26 weeks
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An adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
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26 weeks
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Number of treatment-emergent SAEs from baseline up to Week 26
Time Frame: 26 weeks
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A serious adverse event (SAE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
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26 weeks
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Number of AEs leading to IMP discontinuation up to Week 24
Time Frame: 24 weeks
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The investigational medicinal product (IMP) will be discontinued permanently in case of an AE that, in the opinion of the investigator or sponsor's medical expert, contraindicates further dosing.
The investigator will assess the relationship between investigational medicinal product (IMP) and the adverse event (AE).
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Expert, LEO Pharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0133-1528
- 2021-003543-16 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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