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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04872101
Other study ID # LP0133-1402
Secondary ID 2020-002961-32
Status Completed
Phase Phase 3
First received
Last updated
Start date May 25, 2021
Est. completion date January 6, 2023

Study information

Verified date January 2023
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 16-week study in adult participants with chronic hand eczema (CHE). 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 is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.


Recruitment information / eligibility

Status Completed
Enrollment 473
Est. completion date January 6, 2023
Est. primary completion date December 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4). - 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. 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Belgium LEO Investigational Site Brussels
Belgium LEO Investigational Site Edegem
Belgium LEO Investigational Site Gent
Belgium LEO Investigational Site Kortrijk
Belgium LEO Investigational Site Leuven
Belgium Leo Investigational Site Loverval
Belgium LEO Investigational Site Maldegem
Canada LEO Investigational Site Ajax Ontario
Canada LEO Investigational Site Cobourg Ontario
Canada LEO Investigational Site Etobicoke Ontario
Canada LEO Investigational Site Fredericton New Brunswick
Canada LEO Investigational Site Hamilton Ontario
Canada LEO Investigational Site Surrey British Columbia
Canada LEO Investigational Site Toronto Ontario
Canada LEO Investigational Site Vancouver British Columbia
Canada LEO Investigational Site Waterloo Ontario
Canada LEO Investigational Site Windsor Ontario
Denmark LEO Investigational Site Århus
Denmark LEO Investigational Site Copenhagen
Denmark LEO Investigational Site Hellerup
Germany LEO Investigational Site Aachen
Germany LEO Investigational Site Bad Bentheim
Germany LEO Investigational Site Frankfurt
Germany LEO Investigational Site Friedrichshafen
Germany LEO Invesitgational Site Hannover
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
Netherlands 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
Poland LEO Investigational Site Bialystok
Poland LEO Investigational Site Lublin
Poland LEO Investigational Site Rzeszow
Poland LEO Investigational Site Warszawa
Poland LEO Investigational Site Warszawa
Poland LEO Investigational Site Wroclaw
Poland LEO Investigational Site Wroclaw
Spain LEO Investigational Site Alicante
Spain LEO Investigational Site Badalona Barcelona
Spain LEO Investigational Site Barcelona
Spain LEO Investigational Site Bilbao Vizcaya
Spain LEO Investigational Site Madrid
Spain LEO Investigational Site Mieres Asturias
Spain LEO Investigational Site Sevilla

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 16 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) =4 points. 16 weeks
Secondary Reduction of HESD score (weekly average) of =4 points from baseline at Week 16 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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) =4 points. 16 weeks
Secondary IGA-CHE TS at Week 8 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 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. 8 weeks
Secondary IGA-CHE TS at Week 4 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 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. 4 weeks
Secondary Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 8 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) =4 points. 8 weeks
Secondary Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 4 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) =4 points. 4 weeks
Secondary Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 2 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 and will be evaluated among participants with a baseline HESD itch score (weekly average) =4 points. 2 weeks
Secondary Reduction of HESD score (weekly average) of =4 points from baseline at Week 8 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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) =4 points. 8 weeks
Secondary Reduction of HESD score (weekly average) of =4 points from baseline at Week 4 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. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) =4 points. 4 weeks
Secondary Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 16 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 and will be evaluated among participants with a baseline HESD pain score (weekly average) =4 points. 16 weeks
Secondary Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 8 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 and will be evaluated among participants with a baseline HESD pain score (weekly average) =4 points. 8 weeks
Secondary Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 4 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 and will be evaluated among participants with a baseline HESD pain score (weekly average) =4 points. 4 weeks
Secondary HECSI-90 at Week 16 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. 16 weeks
Secondary HECSI-75 at Week 16 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-75 is defined as at least 75% improvement in HECSI score from baseline. 16 weeks
Secondary HECSI-75 at Week 8 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-75 is defined as at least 75% improvement in HECSI score from baseline. 8 weeks
Secondary Percentage change in HECSI score from baseline to Week 16 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). 16 weeks
Secondary Change in DLQI score from baseline to Week 16 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). 16 weeks
Secondary Change in HESD score (weekly average) from baseline to Week 16 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. The HESD score is derived as the average of the 6 signs and symptoms. 16 weeks
Secondary Change in HESD itch score (weekly average) from baseline to Week 16 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. 16 weeks
Secondary Change in HESD pain score (weekly average) from baseline to Week 16 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. 16 weeks
Secondary Change in HEIS score from baseline to Week 16 The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items. 16 weeks
Secondary Change in HEIS PDAL score from baseline to Week 16 Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). 16 weeks
Secondary Reduction of DLQI score of =4 points from baseline at Week 16 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). This endpoint will be evaluated among participants with a baseline DLQI score =4 points. 16 weeks
Secondary Number of treatment-emergent AEs from baseline up to end of trial per participant 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. End of trial is defined as Week 16 for participants who roll over to the long-term extension trial and as Week 18 for participants who do not roll over. 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
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