Could an existing eczema drug help a rare skin condition?
NCT ID NCT04600362
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 2 trial tests dupilumab (Dupixent), an injectable drug already approved for atopic dermatitis, in 70 adults with nummular eczema, a chronic, itchy skin condition. Participants receive either dupilumab or a placebo for several weeks. The study measures changes in eczema severity and quality of life to see if the drug offers a new treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent), a monoclonal antibody injection
- What this could lead to
- If successful, this could provide a new treatment option for nummular eczema, reducing itching and improving skin appearance.
- What could go wrong
- This is an early Phase 2 trial with only 70 people. Dupilumab is already approved for other eczema types, but its effect on nummular eczema specifically is unproven, and side effects like injection reactions or infections are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinikum re. Isar Dermatology
München, Bavaria, 81675, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.