Status:
COMPLETED
Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Chronic Hand Eczema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Chron...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03861455
Start Date
July 15 2019
End Date
December 20 2023
Last Update
December 3 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Saint André Hospital
Bordeaux, France, 30000
2
Hôpital Saint Eloi
Montpellier, France, 34000
3
CHU Lyon-Sud Département d'allergologie et d'immunologie clinique
Pierre-Bénite, France, 69495
4
Larrey Hospital
Toulouse, France, 31059