study of the efficacy and safety of dupilumab in patients with moderate to severe hand eczema

Phase 1

• Conditions: Chronic hand eczema; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-002830-19-FR
• Lead Sponsor: Toulouse University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-16
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified