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Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids (DUPECZEMAIN)

Primary Purpose

Chronic Hand Eczema

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Dupilumab

placebo

About this trial

This is an interventional treatment trial for Chronic Hand Eczema focused on measuring Chronic Hand Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients affiliated to a social insurance protection regimen.
Patients with moderate to severe chronic (>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4).
Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 [indicating clear] to 2 [indicating mild]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids.
Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires.
Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit.
Patients who agree to sign the written informed consent.

Exclusion Criteria:

Hypersensitivity to dupilumab or to any of its ingredients
Patients under adult autonomy protection system
Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect.
Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline.
Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit.
Treatment with an investigational drug within 8 weeks (or 5 half-lives) of baseline.
Active chronic infection requiring the use of a systemic antibiotic within 2 weeks before study start.
Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit.
Patients with known helminth infections.
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method

Sites / Locations

Saint André HospitalRecruiting
Hôpital Saint EloiRecruiting
Larrey HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

dupilumab group

placebo group

Arm Description

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

patient receive placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Evolution of pain

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).

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).

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.

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).

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)

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)

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.

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.

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

evolution of laboratory parameters - full blood count

The evolution of laboratory parameters (full blood count) at week 16 since baseline

evolution of laboratory parameters - transaminases

The evolution of laboratory parameters (transaminase) at week 16 since baseline

evolution of laboratory parameters - total immunoglobulin E

The evolution of laboratory parameters (total immunoglobulin E) at week 16 since baseline

evolution of laboratory parameters - specific immunoglobulin E

The evolution of laboratory parameters (specific immunoglobulin E) at week 16 since baseline

Full Information

NCT ID

NCT03861455

First Posted

November 28, 2018

Last Updated

August 22, 2023

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT03861455

Brief Title

Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

Acronym

DUPECZEMAIN

Official Title

DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hand Eczema

Keywords

Chronic Hand Eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dupilumab group

Arm Type

Experimental

Arm Description

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

patient receive placebo

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Intervention Description

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

patient receive placebo

Primary Outcome Measure Information:

Title

severity score mTLSS (modified Total Lesion Symptom Score)

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Evolution of pruritus

Description

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).

Time Frame

Week 16

Title

Evolution of pain

Description

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).

Time Frame

Week 16

Title

Improvement of quality of life

Description

Time Frame

Week 16

Title

Improvement of quality of life by EQ-5D-5L

Description

Time Frame

Week 16

Title

evolution of sleep loss

Description

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).

Time Frame

Week 16

Title

IGA - Clearance

Description

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)

Time Frame

Week 16

Title

PaGa - Clearance

Description

Time Frame

Week 16

Title

Improvement of work productivity

Description

Time Frame

Week 16

Title

Evolution of the Eczema Area and Severity Index (EASI)

Description

Time Frame

Week 16

Title

Incidence of Treatment-Emergent Adverse Event

Description

The safety throughout the course of the study (at 20 weeks since baseline) by monitoring adverse events, serious adverse events, injection site reactions

Time Frame

Week 16

Title

evolution of laboratory parameters - full blood count

Description

The evolution of laboratory parameters (full blood count) at week 16 since baseline

Time Frame

Week 16

Title

evolution of laboratory parameters - transaminases

Description

The evolution of laboratory parameters (transaminase) at week 16 since baseline

Time Frame

Week 16

Title

evolution of laboratory parameters - total immunoglobulin E

Description

The evolution of laboratory parameters (total immunoglobulin E) at week 16 since baseline

Time Frame

Week 16

Title

evolution of laboratory parameters - specific immunoglobulin E

Description

The evolution of laboratory parameters (specific immunoglobulin E) at week 16 since baseline

Time Frame

Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients affiliated to a social insurance protection regimen. Patients with moderate to severe chronic (>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4). Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 [indicating clear] to 2 [indicating mild]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids. Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires. Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit. Patients who agree to sign the written informed consent. Exclusion Criteria: Hypersensitivity to dupilumab or to any of its ingredients Patients under adult autonomy protection system Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect. Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline. Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit. Treatment with an investigational drug within 8 weeks (or 5 half-lives) of baseline. Active chronic infection requiring the use of a systemic antibiotic within 2 weeks before study start. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit. Patients with known helminth infections. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie TAUBER, MD

Phone

618569203

Ext

tauber.ma@chu-toulouse.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie Tauber

Organizational Affiliation

Toulouse University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint André Hospital

City

Bordeaux

ZIP/Postal Code

30000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julien Seneschal, MD

First Name & Middle Initial & Last Name & Degree

Julien Seneschal, MD

Facility Name

Hôpital Saint Eloi

City

Montpellier

ZIP/Postal Code

34000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurelie Du Thann, MD

First Name & Middle Initial & Last Name & Degree

Aurelie Du Thann, MD

Facility Name

Larrey Hospital

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie TAUBER, MD

First Name & Middle Initial & Last Name & Degree

Marie TAUBER, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24953620

Citation

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.

Results Reference

background

PubMed Identifier

24102212

Citation

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.

Results Reference

background

PubMed Identifier

25607554

Citation

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.

Results Reference

background

PubMed Identifier

28478972

Citation

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.

Results Reference

background

PubMed Identifier

25244099

Citation

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.

Results Reference

background

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Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

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