Efficacy of Dupilumab for Nummular Eczema
An Investigator-initiated, Multi-center, Randomized, Double-blind, Placebo Controlled Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema
This study is testing if Dupilumab can help people with nummular eczema feel better after 16 weeks of treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Drugs / interventions | Dupilumab |
| Locations | 1 site (München, Bayern) |
| Trial ID | NCT04600362 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Dupilumab, a monoclonal antibody, in treating patients with nummular eczema, a chronic inflammatory skin condition. The primary goal is to assess the change in the Eczema Area and Severity Index (EASI) score after 16 weeks of treatment. Secondary objectives include evaluating improvements in physician assessments, quality of life, and safety measures. The study aims to provide a new therapeutic option for patients who struggle with this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a confirmed diagnosis of nummular eczema and a significant severity score.
Not a fit: Patients with mild nummular eczema or those who have not used topical steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from nummular eczema.
How similar studies have performed: Previous studies have shown promising results using Dupilumab for similar inflammatory skin conditions, suggesting potential success in this application.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
München, Bayern
- Klinikum re. Isar Dermatology — München, Bayern, Germany (Recruiting)
Study contacts
- Principal investigator: Thilo Biedermann, Prof.Dr.med. — Klinikum re. Isar, Technische Universität München, Dermatologie
- Study coordinator: Alexander Böhner, Dr. med.
- Email: alexander.boehner@tum.de
- Phone: +49 (0) 89 4140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.