Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2) (DELTA 2)
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| ClinicalTrials.gov Identifier: NCT04872101 |
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Recruitment Status :
Completed
First Posted : May 4, 2021
Last Update Posted : January 9, 2023
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Sponsor:
LEO Pharma
Information provided by (Responsible Party):
LEO Pharma
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hand Eczema | Drug: Delgocitinib cream Drug: Cream vehicle | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 473 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 25, 2021 |
| Actual Primary Completion Date : | December 27, 2022 |
| Actual Study Completion Date : | January 6, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Experimental: Delgocitinib 20 mg/g
Twice-daily topical application for 16 weeks
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Drug: Delgocitinib cream
Cream for topical application
Other Name: LEO 124249 cream |
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Placebo Comparator: Cream vehicle
Twice-daily topical application for 16 weeks
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Drug: Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient. |
Primary Outcome Measures :
- IGA-CHE TS at Week 16 [ Time Frame: 16 weeks ]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.
Secondary Outcome Measures :
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]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.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]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.
- IGA-CHE TS at Week 8 [ Time Frame: 8 weeks ]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.
- IGA-CHE TS at Week 4 [ Time Frame: 4 weeks ]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.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]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.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]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.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 2 [ Time Frame: 2 weeks ]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.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]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.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]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.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]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.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]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.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]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.
- HECSI-90 at Week 16 [ Time Frame: 16 weeks ]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.
- HECSI-75 at Week 16 [ Time Frame: 16 weeks ]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.
- HECSI-75 at Week 8 [ Time Frame: 8 weeks ]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.
- Percentage change in HECSI score from baseline to Week 16 [ Time Frame: 16 weeks ]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).
- Change in DLQI score from baseline to Week 16 [ Time Frame: 16 weeks ]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).
- Change in HESD score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]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.
- Change in HESD itch score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]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.
- Change in HESD pain score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]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.
- Change in HEIS score from baseline to Week 16 [ Time Frame: 16 weeks ]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.
- Change in HEIS PDAL score from baseline to Week 16 [ Time Frame: 16 weeks ]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).
- Reduction of DLQI score of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]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.
- Number of treatment-emergent AEs from baseline up to end of trial per participant [ Time Frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872101
Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
| Study Director: | Medical Expert | LEO Pharma |
| Responsible Party: | LEO Pharma |
| ClinicalTrials.gov Identifier: | NCT04872101 |
| Other Study ID Numbers: |
LP0133-1402 2020-002961-32 ( EudraCT Number ) |
| First Posted: | May 4, 2021 Key Record Dates |
| Last Update Posted: | January 9, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified IPD can be made available to researchers in a closed environment for a specified period of time. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Data is available to request after results of the trial are available on leopharmatrials.com |
| Access Criteria: | Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement. |
| URL: | http://leopharmatrials.com/for-professionals |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous |