Dupilumab in severe chronic hand eczema patients who do not respond or are intolerant to alitretinoi

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10036145Term: Pompholyx eczemaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; Hand eczema; MedDRA version: 21.1Level: LLTClassification code 10066695Term: Chronic hand dermatitisSystem Organ Class: 100000004858

• Registration Number: EUCTR2019-001561-32-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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 <1% per year when used consistently and correctly) method of birth control, prior to receiving study intervention, during the study and for at least 12 weeks after receiving the last administration of study intervention. E.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant). NOTE: If a female participant’s childbearing potential changes after start of the study (eg, a woman who is not heterosexually active becomes active, a premenarchal woman experiences menarche), she must begin practicing a highly effective method of birth control, as described above.
•A woman of childbearing potential must have a negative serum or urine pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) at screening and at Week 0 prior to administration of study intervention;
•Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
•Agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study intervention.
•Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
•Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study.

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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.