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Clinical Trials in Germany / NCT04600362
Active, not recruiting Phase 2

Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

NCT04600362 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2021-03-30
Last updated
2025-09-23

Condition(s) studied

Nummular Eczema

Investigational drug(s) / intervention(s)

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

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

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 serum pregnancy test within 7 days prior to start of trial. 6. 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. 7. History of continuous use of at least mid-potency topical steroids for the last 8 weeks. 8. Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg. 9. Signed informed consent from patient. 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 before the 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 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). 11.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 µg/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. 16\. ≥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. 17\. Planned or anticipated use of any prohibited medications and procedures during study treatment. 18\. Known history of human immunodeficiency virus (HIV) infection. 19. Established diagnosis 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. Presence of skin comorbidities that may interfere with study assessments. 23. Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell 24. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Klinikum re. Isar Dermatology München Bavaria

More Technical University of Munich trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04600362 on ClinicalTrials.gov ↗ ← All trials in Germany