A randomized, double blind placebo-controlled multicenter study of the efficacy and safety of dupilumab in patients with moderate to severe hand eczema refractory to highly potent topical corticosteroids - DUPECZEMAI

Toulouse University Hospital0 个研究点开始时间: 2018年11月16日最近更新: 2024年8月12日

研究概览

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•-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

•- 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

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