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

Inclusion Criteria:

• Patients affiliated to a social insurance protection regimen.

• Patients with moderate to severe chronic (>6 months) hand eczema with anInvestigator 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 potenttopical corticosteroids. Inadequate response (resistance) to highly potent topicalcorticosteroids is defined as a history of failure to achieve and maintain remissionor 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 potenttopical corticosteroids applied for 14 days or for the maximum duration recommendedfor highly potent topical corticosteroids.

• Patients who are able to understand the study procedures including the ability tocomplete patient-oriented questionnaires.

• Patients who are able to apply a stable dose of emollients within 7 days before thebaseline 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 theinvestigator will impair the ability to evaluate treatment effect.

• Treatment with topical corticosteroids or topical calcineurin inhibitors within oneweek of baseline.

• Treatment with oral immunosuppressants (including cyclosporine, methotrexate,azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks ofbaseline 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 weeksbefore study start.

• Known or suspected history of immunosuppression, including history of invasiveopportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis,coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; orunusually frequent, recurrent, or prolonged infections, per investigator judgment.

• History of human immunodeficiency virus (HIV) infection or positive HIV serology atscreening.

• Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis Cantibody at the screening visit.

• Patients with known helminth infections.

• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeedduring the study. Women of childbearing potential who are sexually active andunwilling to use an adequate birth control method