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

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    94
  • sponsor
    University Hospital, Toulouse
Updated on 12 September 2021

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 Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

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. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. 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 Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

Details
Condition Chronic Hand Eczema
Treatment Placebo, Dupilumab
Clinical Study IdentifierNCT03861455
SponsorUniversity Hospital, Toulouse
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method
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