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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003543-16 | EudraCT Number | ||
| U1111-1284-2242 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delgocitinib cream 20 mg/g | Experimental | Twice-daily topical application for up to 24 weeks |
|
| Alitretinoin capsules 30 mg per capsule | Active Comparator | 1 capsule per day for up to 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib | Drug | Cream for topical application 20 mg/g |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HECSI Score From Baseline to Week 12 | 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) with a higher score indicating greater severity. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HECSI-90 at Week 12 | 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), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. |
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Main inclusion criteria:
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:
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:
Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Graz | 8036 | Austria | |||
| LEO Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40252681 | Result | Gimenez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Osterdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 May 10;405(10490):1676-1688. doi: 10.1016/S0140-6736(25)00001-7. Epub 2025 Apr 16. |
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Randomization was stratified by subtype (hyperkeratotic/non-hyperkeratotic) and region (North America/Europe).
The trial enrolled adult participants with severe CHE and with a documented inadequate response to treatment with TCS or for whom TCS were documented to be otherwise medically inadvisable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for up to 24 weeks. Delgocitinib: Cream for topical application 20 mg/g. There was a possibility to stop treatment after 16 weeks if IGA 0/1 was obtained. |
| FG001 | Alitretinoin Capsules 30 mg Per Capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2022 |
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| Toctino |
| Drug |
1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur |
|
| 12 weeks |
| IGA-CHE TS at Week 12. | 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. | 12 weeks |
| Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | 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 with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'itch' component. | 12 weeks |
| Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | 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 with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component. | 12 weeks |
| AUC of HECSI-90 From Baseline up to Week 24 | 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) with a higher score indicating greater severity. 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. | 24 weeks |
| AUC of Change From Baseline in DLQI Score up to Week 24 | 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); a high score is indicative of a poor quality of life. The area under the curve (AUC) at patient level will be determined from the change from baseline in DLQI score estimated as a piecewise linear function from Week 0 to Week 24. Differences will be analyzed with opposite sign to interpret positive area as improvement in scores and negative area as worsening. | 24 weeks |
| Change in HECSI Score From Baseline to Week 24 | 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) with a higher score indicating greater severity. | 24 weeks |
| Number of Treatment-emergent AEs From Baseline up to Week 26 | 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. | 26 weeks |
| Number of Treatment-emergent SAEs From Baseline up to Week 26 | 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. | 26 weeks |
| Number of AEs Leading to IMP Discontinuation up to Week 24 | 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). | 24 weeks |
| Linz |
| 4010 |
| Austria |
| LEO Pharma Investigational Site | Linz | 4021 | Austria |
| LEO Pharma Investigational Site | Calgary | T2J 7E1 | Canada |
| LEO Pharma Investigational Site | Calgary | T2W 4X9 | Canada |
| LEO Pharma Investigational Site | Edmonton | T6G 1C3 | Canada |
| LEO Pharma Investigational Site | Edmonton | T6W0J5 | Canada |
| LEO Pharma Investigational Site | Guelph | N1L 0B7 | Canada |
| LEO Pharma Investigational Site | London | N6A 2C2 | Canada |
| LEO Pharma investigational site | London | N6A 5R9 | Canada |
| LEO Pharma investigational site | Markham | L3P 1X3 | Canada |
| LEO Pharma investigational site | Niagara Falls | L2H 1H5 | Canada |
| LEO Pharma Investigational Site | North York | M2N 3A6 | Canada |
| LEO Pharma investigational site | Québec | G1W 4R4 | Canada |
| LEO Pharma Investigational Site | Red Deer | T4P 1K4 | Canada |
| LEO Pharma investigational site | Sherbrooke | J1G 1X9 | Canada |
| LEO Pharma Investigational Site | Antony | 92160 | France |
| LEO Pharma Investigational Site | Martigues | 13500 | France |
| LEO Pharma Investigational Site | Montpellier | 34295 | France |
| LEO Pharma Investigational Site | Nice | 06000 | France |
| LEO Pharma investigational site | Nice | 6202 | France |
| LEO Pharma Investigational Site | Reims | 51100 | France |
| LEO Pharma Investigational Site | Toulon | 83000 | France |
| LEO Pharma Investigational Site | Augsburg | 86163 | Germany |
| LEO Pharma Investigational Site | Berlin | 10789 | Germany |
| LEO Pharma Investigational Site | Berlin | 13055 | Germany |
| LEO Pharma Investigational Site | Bochum | 44791 | Germany |
| LEO Pharma Investigational Site | Bochum | 44793 | Germany |
| LEO Pharma Investigational Site | Bonn | 53111 | Germany |
| LEO Pharma Investigational Site | Darmstadt | 64283 | Germany |
| LEO Pharma Investigational Site | Dresden | 01307 | Germany |
| LEO Pharma Investigational Site | Erlangen | 91054 | Germany |
| LEO Pharma Investigational Site | Essen | 45147 | Germany |
| LEO Pharma Investigational Site | Frankfurt | 60590 | Germany |
| LEO Pharma Investigational Site | Friedrichshafen | 88045 | Germany |
| LEO Pharma Investigational Site | Gera | 07548 | Germany |
| LEO Pharma Investigational Site | Göttingen | 37075 | Germany |
| LEO Pharma Investigational Site | Halle | 06110 | Germany |
| LEO Pharma Investigational Site | Hamburg | 22391 | Germany |
| LEO Pharma Investigational Site | Heidelberg | 69120 | Germany |
| LEO Pharma Investigational Site | Langenau | 89129 | Germany |
| LEO Pharma Investigational Site | Löhne | 49393 | Germany |
| LEO Pharma Investigational Site | Mainz | 55131 | Germany |
| LEO Pharma Investigational Site | Marburg | 35043 | Germany |
| LEO Pharma Investigational Site | Memmingen | 87700 | Germany |
| LEO Pharma Investigational Site | München | 80337 | Germany |
| LEO Pharma Investigational Site | München | 80802 | Germany |
| LEO Pharma Investigational Site | Oldenburg | 26133 | Germany |
| LEO Pharma Investigational Site | Osnabrück | 49074 | Germany |
| LEO Pharma Investigational Site | Wuppertal | 42287 | Germany |
| LEO Pharma Investigational Site | Bologna | 40138 | Italy |
| LEO Pharma Investigational Site | Brescia | 25123 | Italy |
| LEO Pharma Investigational Site | Catania | 95123 | Italy |
| LEO Pharma Investigational Site | Catanzaro | 88100 | Italy |
| LEO Pharma Investigational Site | Genova | 16132 | Italy |
| LEO Pharma Investigational Site | Lucca | 55100 | Italy |
| LEO Pharma Investigational Site | Milan | 20089 | Italy |
| LEO Pharma Investigational Site | Pavia | 27100 | Italy |
| LEO Pharma Investigational Site | Pisa | 56126 | Italy |
| LEO Pharma Investigational Site | Terracina | 4019 | Italy |
| LEO Pharma Investigational Site | Stavanger | 4011 | Norway |
| LEO Pharma Investigational Site | Tromsø | 9038 | Norway |
| LEO Pharma Investigational Site | Bialystok | 15-794 | Poland |
| LEO Pharma investigational site | Bydgoszcz | 85-796 | Poland |
| LEO Pharma Investigational Site | Chorzów | 41-500 | Poland |
| LEO Pharma Investigational Site | Gdansk | 80-546 | Poland |
| LEO Pharma Investigational Site | Gdynia | 81-338 | Poland |
| LEO Pharma Investigational Site | Katowice | 40-081 | Poland |
| LEO Pharma investigational site | Katowice | 40-611 | Poland |
| LEO Pharma investigational site | Katowice | 40-851 | Poland |
| LEO Pharma Investigational Site | Krakow | 30-033 | Poland |
| LEO Pharma Investigational Site | Krakow | 30-727 | Poland |
| LEO Pharma Investigational Site | Krakow | 31-501 | Poland |
| LEO Pharma Investigational Site | Lodz | 90-436 | Poland |
| LEO Pharma Investigational Site | Lublin | 20-080 | Poland |
| LEO Pharma Investigational Site | Poznan | 61-731 | Poland |
| LEO Pharma Investigational Site | Strzelce Opolskie | 47-100 | Poland |
| LEO Pharma Investigational Site | Szczecin | 71-434 | Poland |
| LEO Pharma Investigational Site | Warsaw | 02-677 | Poland |
| LEO Pharma Investigational Site | Wroclaw | 51-685 | Poland |
| LEO Pharma Investigational Site | Bratislava | 851 01 | Slovakia |
| LEO Pharma Investigational Site | Svidník | 089 01 | Slovakia |
| LEO Pharma Investigational Site | Trnava | 917 75 | Slovakia |
| LEO Pharma Investigational Site | Alcalá de Henares | 28805 | Spain |
| LEO Pharma Investigational Site | Alicante | 03010 | Spain |
| LEO Pharma Investigational Site | Badalona | 08916 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08003 | Spain |
| LEO Pharma Investigational Site | Barcelona | 08025 | Spain |
| LEO Pharma Investigational Site | Córdoba | 14004 | Spain |
| LEO Pharma Investigational Site | L'Hospitalet de Llobregat | 08907 | Spain |
| LEO Pharma Investigational Site | Madrid | 28006 | Spain |
| LEO Pharma Investigational Site | Madrid | 28034 | Spain |
| LEO Pharma Investigational Site | Madrid | 28040 | Spain |
| LEO Pharma Investigational Site | Madrid | 28041 | Spain |
| LEO Pharma investigational site | Málaga | 29009 | Spain |
| LEO Pharma investigational site | Pontevedra | 36071 | Spain |
| LEO Pharma Investigational Site | Seville | 41009 | Spain |
| LEO Pharma Investigational Site | Valencia | 46014 | Spain |
| LEO Pharma Investigational Site | Valencia | 46026 | Spain |
| LEO Pharma Investigational Site | Zaragoza | 50009 | Spain |
| LEO Pharma Investigational Site | London | SE1 9RT | United Kingdom |
| LEO Pharma Investigational Site | Nottingham | NG7 2UH | United Kingdom |
1 capsule per day for up to 24 weeks Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur. There was a possibility to stop treatment after 12 weeks if IGA 0/1 was obtained. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for up to 24 weeks> > Delgocitinib: Cream for topical application 20 mg/g |
| BG001 | Alitretinoin Capsules 30 mg Per Capsule | 1 capsule per day for up to 24 weeks> > Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HECSI Score From Baseline to Week 12 | 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) with a higher score indicating greater severity. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
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| Secondary | HECSI-90 at Week 12 | 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), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | IGA-CHE TS at Week 12. | 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. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Change in HESD Itch Score (Weekly Average) From Baseline to Week 12 | 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 with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'itch' component. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
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| Secondary | Change in HESD Pain Score (Weekly Average) From Baseline to Week 12. | 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 with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
|
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| Secondary | AUC of HECSI-90 From Baseline up to Week 24 | 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) with a higher score indicating greater severity. 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. | Posted | Mean | Standard Error | days with 90% reduction in HECSI score | 24 weeks |
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| Secondary | AUC of Change From Baseline in DLQI Score up to Week 24 | 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); a high score is indicative of a poor quality of life. The area under the curve (AUC) at patient level will be determined from the change from baseline in DLQI score estimated as a piecewise linear function from Week 0 to Week 24. Differences will be analyzed with opposite sign to interpret positive area as improvement in scores and negative area as worsening. | Posted | Mean | Standard Error | days * DLQI score reduction | 24 weeks |
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| Secondary | Change in HECSI Score From Baseline to Week 24 | 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) with a higher score indicating greater severity. | Posted | Mean | Standard Error | score on a scale | 24 weeks |
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| Secondary | Number of Treatment-emergent AEs From Baseline up to Week 26 | 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. | Posted | Number | events | 26 weeks |
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| Secondary | Number of Treatment-emergent SAEs From Baseline up to Week 26 | 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. | Posted | Number | events | 26 weeks |
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| Secondary | Number of AEs Leading to IMP Discontinuation up to Week 24 | 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). | Posted | Number | events | 24 weeks |
|
|
From baseline to Week 26
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delgocitinib Cream 20 mg/g | Delgocitinib Cream 20 mg/g (N=253) | 0 | 253 | 5 | 253 | 58 | 253 |
| EG001 | Alitretinoin Capsules 30 mg Per Capsule | Alitretinoin Capsules 30 mg Per Capsule (N=247) | 0 | 247 | 12 | 247 | 143 | 247 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis postoperative | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Mediastinal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
|
The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | LEO Pharma | +4544945888 | disclosure@leo-pharma.com |
| Jun 25, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000621572 | delgocitinib |
| D000077556 | Alitretinoin |
| ID | Term |
|---|---|
| D014212 | Tretinoin |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Norway |
|
| Poland |
|
| Italy |
|
| United Kingdom |
|
| Slovakia |
|
| France |
|
| Germany |
|
| Spain |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|