Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Lebrikizumab for adults with nummular eczema

Official title: A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema Who Are Not Adequately Controlled With Topical Corticosteroids or When This Treatment is Not Medically Advisable (LUMINE)

Run by Almirall, S.A. · NCT07542483 · Data updated 2026-11-12

This study tests whether lebrikizumab can help adults with nummular eczema who don’t respond well to topical steroids.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment270 (estimated)
SponsorAlmirall, S.A.
Industry-sponsored
Drugs / interventionslebrikizumab, dupilumab, tralokinumab
Locations1 site (Freiburg im Breisgau)
StatusRecruiting
StartedApril 24, 2026
Main results expectedAugust 2028
Study endsFebruary 2029
Registry record updatedAugust 17, 2026
Trial IDNCT07542483 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 and older with a confirmed diagnosis of nummular eczema for at least 6 months and inadequate response to topical corticosteroids.

Probably not a fit

Patients with history of moderate-to-severe atopic dermatitis or other disqualifying conditions may not see benefit and could experience study-related risks.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 interventional trial, adults with clinically diagnosed nummular eczema and moderate-to-severe signs will receive lebrikizumab or placebo to determine its safety and how well it works when topical corticosteroids are not enough or are not advisable. Participants will be evaluated for changes in skin symptoms, tolerability, and overall disease impact over a defined treatment period. The study aims to clarify whether lebrikizumab provides meaningful relief beyond standard care. Recruitment is planned at a site in Freiburg im Breisgau, under Almirall, S.A. sponsorship.

Why it matters

Potential benefit: If successful, participants may experience improvements in skin symptoms and quality of life related to nummular eczema.

How similar studies have gone: Other studies of targeted biologics in similar dermatitis conditions have shown potential benefits, though this exact approach for nummular eczema is being explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants eligible for inclusion in this trial must fulfil all inclusion criteria per protocol, main criteria are listed below:

* Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines.
* Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
* Presence of nummular eczema signs and/or symptoms for at least 6 months prior to Screening.
* Investigator Global Assessment score \>=3 at both Screening and Baseline/Day 1 visits.
* In the judgement of the Investigator, having inadequate response to TCS.

Exclusion Criteria:

Participants fulfilling any of the exclusion criteria per protocol are not eligible for inclusion in this trial main criteria are listed below:

* Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI \>=16).
* Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).
* Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.
* Prior treatment at any time with lebrikizumab, dupilumab, tralokinumab, or oral Janus kinase inhibitor.
* Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, prior to Screening.
* Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
* History of anaphylaxis as defined by the Sampson criteria.
* Uncontrolled chronic disease that might require multiple intermittent uses of systemic corticosteroids, eg, uncontrolled asthma.
* Have had any of the following types of infection within 3 months of Screening or develop any of these infections before Baseline/Day 1:

  1. Serious (requiring hospitalisation and/or intravenous or equivalent oral antibiotic treatment, per the Investigator's opinion)
  2. Opportunistic (as defined by Winthrop 2015) Note: herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
  3. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer), including hepatitis B virus and hepatitis C virus infections
  4. Recurring (including but not limited to herpes zoster, recurring cellulitis, and chronic osteomyelitis) with the exception of uncomplicated herpes simplex infection, which is not considered exclusionary
* Known liver cirrhosis and/or chronic hepatitis of any aetiology.
* Diagnosed active endoparasitic infections or at high risk of these infections.
* Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
* History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
* In the Investigator's opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit.
* History of malignancy, including mycosis fungoides/cutaneous T-cell lymphoma, within 5 years before the Screening visit, except for completely treated in situ carcinoma of the cervix or completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
* Severe concomitant illness(es) that in the Investigator's judgement would adversely affect the participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant because of their participation in this clinical trial, may make participation unreliable, or may interfere with study assessments.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* History of sensitivity and/or allergy to any of the ingredients of the trial medication.

Where it's running

  • Alm Site 1
    Freiburg im Breisgau, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.