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

Chronic Hand Eczema Clinical Trial

— DELTA 2  

Official title:

A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 2)

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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Hand Eczema
• Eczema

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])