Chronic hand eczema
Conditions
Interventions
Trade Name: DUPIXENT
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration
Sponsors
Toulouse University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult Patients (=18 years) 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 -Patients intolerant or resistant to 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 94 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that dupilumab is more effective than placebo for the treatment of patients with moderate to severe chronic hand eczema (CHE) who are resistant or intolerant to highly potent topical corticosteroids as determined by the evolution at week 16 of the mTLSS since baseline.;Secondary Objective: -To demonstrate that dupilumab is more effective than placebo to improve pruritus at week 16. -To demonstrate that dupilumab is more effective than placebo to improve pain at week 16 -To demonstrate that dupilumab is more effective than placebo to improve quality of life at week 16. -To demonstrate that dupilumab is more effective than placebo to improve sleep loss at week 16. -To demonstrate that dupilumab is more effective than placebo to induce clearance or almost clearance at week 16. -To demonstrate that dupilumab is more effective than placebo to improve work productivity at week 16. -To evaluate the efficacy of dupilumab on other parts of the body as compared to placebo, in the expected 50% of patients who have eczema not limited to the hand. -To evaluate the safety of dupilumab as compared to placebo. -To evaluate the evolution of laboratory parameters of patients receiving dupilumab compared to those receiving placebo. ;Primary end point(s): -The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score ). ;Timepoint(s) of evaluation of this end point: every 2 weeks from baseline to 16 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evolution of pruritus associated with CHE at week 16 since baseline measured with a visual analog scale . - Evolution of pain associated with CHE at week 16 since baseline measured with a visual analog scale . - Improvement of quality of life at week 16 since baseline measured by DLQI (Dermatology Life Quality Index) and EQ-5D. - Evolution of sleep loss associated with CHE at week 16 since baseline measured with a visual analog scale . - Clearance or almost clearance of hand eczema at week 16 as defined by an Investigator’s global assessment (IGA ) of 0 or 1. - Clearance or almost clearance of hand eczema at week 16 as assessed by the Patient’s global assessment (PaGa) of 0 or 1. - Improvement of work productivity at week 16 since baseline as assessed by the WPAI questionnaire (Work Productivity and Activity Impairment). - 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 safety throughout the course of the study (at 20 weeks since baseline) by monitoring adverse events, serious adverse events, injection site reactions. - The evolution of laboratory parameters (full blood count, transaminases, total IgE and specific IgE) at week 16 since baseline. ;Timepoint(s) of evaluation of this end point: every 2 weeks from baseline to 16-week (only safety to 20 weeks) | — |
Countries
France
Contacts
Public ContactALGANS
Toulouse University Hospital
Outcome results
None listed