Hand eczema MedDRA version: 21.1 Level: LLT Classification code 10066695 Term: Chronic hand dermatitis System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10036145 Term: Pompholyx eczema System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Dupixent
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pre
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years and = 75 years. • Severe or very severe chronic hand eczema as defined by a Physician Global Assessment (PGA) using a validated Photoguide. • Inflammatory subtypes of hand eczema: recurrent vesicular hand eczema or chronic fissured hand eczema. • An inadequate response to topical corticosteroids within 6 months before screening. • A history of prior alitretinoin exposure and inadequate response or intolerance to alitretinoin. • Patients has also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement. • Patients has avoided irritants and contact allergens, if identified, without significant improvement. • Women of childbearing potential are required to use a highly effective (failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Other clinical subtypes of hand eczema, e.g. hyperkeratotic hand eczema, as defined by the Danish Contact Dermatitis Group. • Treatment with alitretinoin, systemic immunosuppressive medication or UV radiation within the previous 4 weeks. • Patients with predominantly atopic dermatitis, in whom the hands are also involved, but no main concern. • Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion. • Psoriasis of the hands. • Active bacterial, fungal, or viral infection of the hands. • Pregnant/lactating or planning to become pregnant during the study period. • Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix). • Participant has known allergies, hypersensitivity, or intolerance to dupilumab or its excipients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, acetic acid, sucrose, water for injections. • Participants with active helminth and other parasitic infections. • Patients infected with human immunodeficiency virus (HIV), positive serology for HIV antibody). • Patients testing positive for hepatitis B virus (HBV) or hepatitis C (HCV) infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of dupilumab in patients with inflammatory subtypes of severe chronic hand eczema with an inadequate response or intolerance to alitretinoin.;Secondary Objective: To evaluate health related quality of life; to evaluate improvement in severity of hand eczema, assessed by the patient; to evaluate work productivity and impairment.;Primary end point(s): • Response to treatment is defined as an improvement of = 2 steps on the PGA. Very severe hand eczema is defined as responding to treatment if a status of at least ‘moderate’ is achieved. Severe hand eczema is defined as responding to treatment if a status of at least ‘almost clear’ is achieved. The PGA, based on a validated Photoguide developed by Coenraads et al, covers 5 degrees of severity (clear, almost clear, moderate, severe, very severe) and takes into account the intensity of clinical signs and percentage of hand surface involved. ;Timepoint(s) of evaluation of this end point: Baseline and week 16 visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Severity of hand eczema • The difference of the Hand Eczema Severity Index (HECSI) score between baseline and week 4, 8, 12 and 16 respectively. The HECSI is an objective severity assessment based on clinical symptoms only. It includes erythema, fissures, vesicles, scaling, oedema, papules and measurement of the affected area. The score ranges from 0-360, with a score > 28 indicating severe hand eczema. Quality of life • The difference of The Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) score between baseline and week 4, 8, 12 and 16 respectively. The QOLHEQ is a multi-domain disease specific instrument for hand eczema assessing impairments in quality of life. The score ranges from 0-120, with 120 indicating worst quality of life. • The difference between the Dermatology Life Quality Index score between baseline and week 4, 8, 12 and 16 respectively. Patient reported improvement • Patient Global Assessment (PaGA) in patients reporting improvement as ‘clear or almost clear’ compared to baseline at week 4, 8 and 16. The PaGA takes signs and symptoms into account. It covers 6 degrees of improvement: ‘clear or almost clear’ (at least 90% clearing of disease signs and symptoms compared to baseline), ‘marked improvement’ (at least 75% clearing), ‘moderate improvement’ (at least 50% clearing), ‘mild improvement’ (at least 25% clearing), ‘no change’, or ‘worsening’. Work productivity and impairment • Work productivity and impairment questionnaire (WPAI) at week 16 compared to baseline. Exploratory assessments (substudy) • Comparison to baseline of genomic changes due to dupilumab at week 16 in active HE lesions and changes in the HE transcriptome defined by gene expression differences between lesional and non-lesional skin between and within cases. • Comparison to baseline of the effects of dupilumab treatment at week 16 on histologic morphology, including the effect on epidermal hyperplasia. • Comparison to baseline of treatment-re | — |
Countries
Netherlands
Contacts
Public ContactMarie-Louise Schuttelaar
University Medical Center Groningen
Outcome results
None listed