Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

Last updated: April 22, 2024
Sponsor: Technical University of Munich
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Rash

Hives (Urticaria)

Treatment

Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Clinical Study ID

NCT04600362
SGZ-2018-12012
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically confirmed diagnosis of NE.
  2. Biopsy-proven, meaning histology consistent with eczema (including PAS-staining).
  3. EASI score ≥ 10.
  4. PGA ≥ 3 on a 5 point scale.
  5. Female patients with reproductive potential must have a negative urine or serumpregnancy test within 7 days prior to start of trial.
  6. Female participants who are not capable of bearing children or who use a method ofcontraception that is medically approved by the health authority of the respectivecountry at screening. Effective contraception (CTFG guideline) for women ofchildbearing potential should be used throughout the study, including during thefollow-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.
  7. History of continuous use of at least mid-potency topical steroids for the last 8weeks.
  8. Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg.
  9. Signed informed consent from patient.

Exclusion

Exclusion Criteria:

  1. Permanent severe diseases, especially those affecting the immune system.
  2. Pregnancy or breast feeding.
  3. Active chronic or acute infection requiring systemic treatment within 2 weeks beforethe baseline visit, independent from of the cuntaneous dysbiosis found in NE.
  4. Treatment with an investigational drug within 8 weeks before the baseline visit.
  5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
  6. Diagnosed active endoparasitic infections or at high risk of these infections.
  7. Evidence of severe renal dysfunction 8.Evidence of significant hepatic disease 9.Patients who are considered potentially unreliable or where it is envisaged thepatient may not consistently attend scheduled study visits. 10.Inability orunwillingness to undergo repeated venipuncture (e.g., because of poor tolerability orlack of access to veins).

11.Inability or unwillingness to undergo repeated punch biopsies. 12.History of allergy toany component of the study medication. 13.Evidence of acute contact dermatitis atscreening. 14.Evidence of Zink deficiency defined as Zink level < 20 µg/dL in serum. 15.History of important side effects of medium potency topical corticosteroids (eg,intolerance to treatment, hypersensitivity reactions*, significant skin atrophy, systemiceffects), as assessed by the investigator or patient's treating physician. 16. ≥30% of the total lesional surface located on areas of thin skin that cannot be safelytreated with medium potency TCS (eg, face, neck, intertriginous areas, genital areas, areasof skin atrophy) at baseline. 17. Planned or anticipated use of any prohibited medications and procedures during studytreatment. 18. Known history of human immunodeficiency virus (HIV) infection. 19. Establisheddiagnosis of Hepatitis B viral infection at the time of screening. 20. Established diagnosis of hepatitis C viral infection at the time of screening. 21. History of past or current tuberculosis or other mycobacterial infection. 22. Presenceof skin comorbidities that may interfere with study assessments. 23. Malignancy within 5years of the screening visit excluding local cutaneous squamous cell 24. Severe concomitantillness(es) 25. Any other medical or psychological condition including relevant laboratoryabnormalities at Screening 26. Planned major surgical procedure during the patient'sparticipation in this study.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Phase: 2
Study Start date:
March 30, 2021
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Klinikum re. Isar Dermatology

    München, Bayern 81675
    Germany

    Active - Recruiting

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