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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002830-19 | EudraCT Number |
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Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
Chronic hand eczema is a frequent chronic inflammatory skin disease which may have significant physical, psychological and social impact on daily activities, emotional and social life as well as work. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dupilumab group | Experimental | patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 |
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| placebo group | Placebo Comparator | patient receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 |
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| Measure | Description | Time Frame |
|---|---|---|
| severity score mTLSS (modified Total Lesion Symptom Score) | The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score) The mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain. The seven individual CHE symptoms; (erythema, scaling, lichenification or hyperkeratosis, vesiculation, edema, fissures, and pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of pruritus | Evolution of pruritus associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale (VAE) from 0 (no itching) to 100 (intense itching). | Week 16 |
| Evolution of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Tauber | Lyon Sud Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint André Hospital | Bordeaux | 30000 | France | |||
| HĂ´pital Saint Eloi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24953620 | Background | Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. French. | |
| 24102212 | Background | Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, De Pita O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19. |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Patients will be randomized 1:1 to receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 or placebo.
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| placebo | Drug | patient receive placebo |
|
Evolution of pain associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale from 0 (no pain) to 100 (intense skin pain).
| Week 16 |
| Improvement of quality of life | Improvement of quality of life at week 16 since baseline measured by DLQI (Dermatology Life Quality Index) composed of 10 questions (4 possibilities per questions: very much, a lot, a little, not at all). | Week 16 |
| Improvement of quality of life by EQ-5D-5L | Improvement of quality of life at week 16 since baseline measured by EQ-5D-5L. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his or her current health state using a 0 to 100 mm VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his or her health state by ticking (or placing a cross) in the box associated with the most appropriate statement in each of the 5 dimensions. The VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labeled "best imaginable health state" and "worst imaginable health state." This information can be used as a quantitative measure of health outcome. | Week 16 |
| evolution of sleep loss | Evolution of sleep loss associated with Chronic Hands Eczema at week 16 since baseline measured with a visual analog scale from 0 (no sleep disorder) to 100 (severe sleep loss). | Week 16 |
| IGA - Clearance | Clearance or almost clearance of hand eczema at week 16 as defined by an Investigator's global assessment (IGA) of 0 or 1, on a 5 range scale ( from 0 = Clear to 4 = severe disease) | Week 16 |
| PaGa - Clearance | Clearance or almost clearance of hand eczema at week 16 as assessed by the Patient's global assessment (PaGa) of 0 or 1. The PGA is a single-item question asking the patient how they would rate their overall symptoms. The 5 categories of responses range from "no symptoms"(0) to "severe."(4) | Week 16 |
| Improvement of work productivity | Improvement of work productivity at week 16 since baseline as assessed by the WPAI questionnaire (Work Productivity and Activity Impairment). The WPAI consists of 6 items grouped into 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. Scores are calculated as impairment percentages, with higher scores indicating greater impairment and less productivity. | Week 16 |
| Evolution of the Eczema Area and Severity Index (EASI) | Evolution of the Eczema Area and Severity Index at week 16 since baseline in patients who have eczema on other parts of the body than the hands. The EASI score ranges are between 0 (no eczema) and 72. Higher values represent a worse outcome. | Week 16 |
| Incidence of Treatment-Emergent Adverse Event | The safety throughout the course of the study (at 20 weeks since baseline) by monitoring adverse events, serious adverse events, injection site reactions | Week 16 |
| evolution of laboratory parameters - full blood count | The evolution of laboratory parameters (full blood count) at week 16 since baseline | Week 16 |
| evolution of laboratory parameters - transaminases | The evolution of laboratory parameters (transaminase) at week 16 since baseline | Week 16 |
| evolution of laboratory parameters - total immunoglobulin E | The evolution of laboratory parameters (total immunoglobulin E) at week 16 since baseline | Week 16 |
| evolution of laboratory parameters - specific immunoglobulin E | The evolution of laboratory parameters (specific immunoglobulin E) at week 16 since baseline | Week 16 |
| Montpellier |
| 34000 |
| France |
| CHU Lyon-Sud DĂ©partement d'allergologie et d'immunologie clinique | Pierre-BĂ©nite | 69495 | France |
| Larrey Hospital | Toulouse | 31059 | France |
| 25607554 | Background | Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204. |
| 28478972 | Background | Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4. |
| 25244099 | Background | Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letule V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26. |