Active — Not RecruitingPhase 2

Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

Germany70 participantsStarted 2021-03-30

Plain-language summary

Nummular eczema (NE) is an idiopathic chronic inflammatory skin disease that occurs throughout all life periods. Diagnosis is made primarily clinically in correlation with histological findings. Treatment of NE is difficult. Standard treatment consists of the use of emollients, topical as well as systemic corticosteroids and phototherapy. Nevertheless, remission is hard to achieve and relapse occurs often. Patients usually suffer from severe pruritus and reduced quality of life. Therefore, new therapeutic strategies are urgently needed. Dupilumab (Dupixent®), a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD). Since there is an overlap between AD and NE with both being caused by impaired epidermal barrier, broad immune-mediated inflammation and microbial skin colonization, using Dupilumab in NE seems to be promising.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Clinically confirmed diagnosis of NE.
✓. Biopsy-proven, meaning histology consistent with eczema (including PAS-staining).
✓. EASI score ≥ 10.
✓. PGA ≥ 3 on a 5 point scale.
✓. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
✓. Female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening. Effective contraception (CTFG guideline) for women of childbearing potential should be used throughout the study, including during the follow-up period or at least 120 days after last dose, whichever is longer (elapse of 4-5 half-lives). The event of pregnancy, Dupilumab should be immediately discontinued.
✓. History of continuous use of at least mid-potency topical steroids for the last 8 weeks.
✓. Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg.

Exclusion criteria

What they're measuring

EASI

Timeframe: From baseline to week 16.

Trial details

NCT IDNCT04600362

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Nummular Eczema trials