Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Collaborator: University Hospital Munich
• Treatments: Antibodies, Monoclonal

Criteria

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. History of malignancy at any time before the baseline visit.

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.