Dupilumab in Severe Chronic Hand Eczema

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    30
  • sponsor
    University Medical Center Groningen
Updated on 25 January 2021

Summary

The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.

Details
Condition Hand Dermatitis, Hand Eczema
Treatment Placebo, Dupilumab
Clinical Study IdentifierNCT04512339
SponsorUniversity Medical Center Groningen
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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 10 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 (e.g., 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 (-human chorionic gonadotropin [-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 Bacillus Calmette-Gurin (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

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study
Other clinical subtypes of hand eczema, e.g. hyperkeratotic hand eczema, as defined by the Danish Contact Dermatitis Group24
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 andor 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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