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

Toulouse University Hospital

Status and phase: Completed; Phase 2

Conditions: Chronic Hand Eczema

Treatments: Drug: placebo; Drug: Dupilumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03861455

RC31/18/0269

2018-002830-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

dupilumab group

Experimental group

Description:

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

Treatment:

Drug: Dupilumab

placebo group

Placebo Comparator group

Description:

patient receive placebo

Treatment:

Drug: placebo