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Nummular EczemaPhase 2DUPINUMNCT04600362

Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

A Phase 2 study testing Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] in people with Nummular Eczema, run by Technical University of Munich at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Nummular Eczema
What is being tested?
Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteGermany
Study dates
30 Mar 2021to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically confirmed diagnosis of NE.
  • Biopsy-proven, meaning histology consistent with eczema (including PAS-staining).
  • EASI score ≥ 10.
  • PGA ≥ 3 on a 5 point scale.
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
  • 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.
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  • History of continuous use of at least mid-potency topical steroids for the last 8 weeks.
  • Age 18-85 years of age, body weight ≥ 40 kg and ≤ 160 kg.
  • Signed informed consent from patient.

Who cannot join

  • Permanent severe diseases, especially those affecting the immune system.
  • Pregnancy or breast feeding.
  • Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit, independent from of the cuntaneous dysbiosis found in NE.
  • Treatment with an investigational drug within 8 weeks before the baseline visit.
  • Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
  • Diagnosed active endoparasitic infections or at high risk of these infections.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum re. Isar Dermatology

    München, Bavaria, 81675

Other trials in Germany

About this study

Official title: An Investigator-initiated, Multi-center, Randomized, Double-blind, Placebo Controlled Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema

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.

Read the detailed 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.

Conditions
Nummular Eczema
Being tested
Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Keywords
Nummular Eczema, Dermatitis, Skin Diseases, Dupilumab, Anti-Inflammatory-Sgents
Medical subject headings
Dermatitis, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Subcutaneous

Study groups in NCT04600362
Study groupRoleWhat they receive
DupilumabExperimentalPatients randomized to this arm will receive two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by single 300 mg injection of Dupilumab every 2 weeks (q2w) from week 2 to week 16.
Receives: Drug: Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
PlaceboPlacebo comparatorPatients randomized to this arm will receive identically matching doses of placebo. Two subcutaneous injections of placebo as a loading dose (to mimic the experimental Dupilumab arm) on Day 1 followed by a single injection q2w from Week 2 to Week 16.
Receives: Drug: Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EASI

    The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score.

    Measured: From baseline to week 16.

Secondary outcomes (10)

  1. PGA

    Number of Patients Achieving an Improvement (Decrease) in Physician Global Assessment (PGA) by two or more points

    Measured: at week 16 as compared to week 0

  2. PGA

    Number of Patients achieving an absolute PGA of 0 or 1

    Measured: at Week 16.

  3. EASI

    The proportion of subjects who achieve at least a 50% reduction in the EASI score

    Measured: From baseline to week 16

  4. TEWL

    Restoration of epidermal barrier function assessed by TEWL (Transepidermal Waterloss) will be measured using AquaFlux BIOX.

    Measured: From baseline to week 16

  5. histological improvement

    Assessed by reduction of epidermal thickness > 30% or reduction of inflammatory infiltrate > 50 %

    Measured: From baseline to week 16

  6. Reduction of the Use of Topical Steroids

    Prior to randomization and during the treatment, average application rate of class II topical steroids (standard medication "prednicarbate") per day will be calculated

    Measured: From baseline to week 16

  7. DLQI

    Change from Baseline in the Dermatology Life Quality Index (DLQI)

    Measured: Total Score at Week 16

  8. VAS

    Pruritus Visual Analog Scale

    Measured: Total Score at Week 16

  9. TSQM

    Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication

    Measured: Total Score at Week 16

  10. Adverse Events

    Type, incidence, severity, and relationship of the AEs to study medication

    Measured: From baseline to week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start30 Mar 2021
  3. Primary completion1 Sep 2025
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an investigator-initiated, multi-center, prospective, randomized, double-blind, interventional phase II study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600362
Sponsor's protocol ID
SGZ-2018-12012
Acronym
DUPINUM
Status last verified
Jun 2025
First submitted
19 Oct 2020
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All participant data collected during the clinical trial (pseudonymized)

Publications

  • Bohner A, Jargosch M, Muller NS, Garzorz-Stark N, Pilz C, Lauffer F, Wang R, Roenneberg S, Zink A, Thomas J, Theis FJ, Biedermann T, Eyerich S, Eyerich K. The neglected twin: Nummular eczema is a variant of atopic dermatitis with codominant TH2/TH17 immune response. J Allergy Clin Immunol. 2023 Aug;152(2):408-419. doi: 10.1016/j.jaci.2023.04.009. Epub 2023 Apr 27.

    PubMed 37119871

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] in people with Nummular Eczema, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EASI (time frame: From baseline to week 16.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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