Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    70
  • sponsor
    Technische Universität München
Updated on 29 March 2021

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.

Description

This study aims on investigating the efficacy of Dupilumab in NE patients. The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16.

Secondary endpoints include the number of patients achieving an improvement (decrease) in Physician Global Assessment (PGA) by two or more points at week 16 as compared to week 0 or achieving an absolute PGA of 0 or 1 at Week 16, the EASI 50 score at week 16, the change from baseline in transepidermal waterloss (TEWL) at week 16, significant histological improvement at week 16, change from baseline in the reduction of the use of topical steroids at week 16, change form baseline in the Dermatology Life Quality Index (DLQI) at week 16, change from baseline in Pruritus Visual Analog Scale (VAS), change from baseline in the global satisfaction subscale of the treatment satisfaction questionnaire for medication (TSQM) score at week 16 and the safety of Dupilumab.

Details
Condition Nummular Eczema
Treatment Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Clinical Study IdentifierNCT04600362
SponsorTechnische Universität München
Last Modified on29 March 2021

Eligibility

Yes No Not Sure

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
Signed informed consent from patient

Exclusion Criteria

Permanent severe diseases, especially those affecting the immune system
Pregnancy or breast feeding
Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, independent from of the cuntaneous dysbiosis found in NE
Treatment with an investigational drug within 8 weeks before the baseline visit
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Diagnosed active endoparasitic infections or at high risk of these infections
Evidence of severe renal dysfunction 8.Evidence of significant hepatic disease 9.Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits. 10.Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins)
Inability or unwillingness to undergo repeated punch biopsies. 12.History
of allergy to any component of the study medication. 13.Evidence of acute
contact dermatitis at screening. 14.Evidence of Zink deficiency defined as
Zink level < 20 g/dL in serum. 15.History of important side effects of medium
potency topical corticosteroids (eg, intolerance to treatment
hypersensitivity reactions, significant skin atrophy, systemic effects), as
assessed by the investigator or patient's treating physician
\. 30% of the total lesional surface located on areas of thin skin that
cannot be safely treated with medium potency TCS (eg, face, neck
intertriginous areas, genital areas, areas of skin atrophy) at baseline
\. Planned or anticipated use of any prohibited medications and procedures
during study treatment
\. Known history of human immunodeficiency virus (HIV) infection. 19
Established diagnosis of Hepatitis B viral infection at the time of screening
\. Established diagnosis of hepatitis C viral infection at the time of
screening
\. History of past or current tuberculosis or other mycobacterial infection
Presence of skin comorbidities that may interfere with study assessments
History of malignancy at any time before the baseline visit
\. Severe concomitant illness(es) 25. Any other medical or psychological
condition including relevant laboratory abnormalities at Screening 26. Planned
major surgical procedure during the patient's participation in this study
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