New shot could help eczema sufferers who Don't respond to steroids
NCT ID NCT07542483
First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This Phase 3 study tests whether lebrikizumab, an injectable drug, can safely and effectively treat nummular eczema in adults who haven't gotten enough relief from topical steroids or can't use them. About 270 participants will receive either lebrikizumab or a placebo injection. The main goal is to see if the drug can clear or nearly clear the eczema patches after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lebrikizumab (injection)
- What this could lead to
- If it works, this could provide a new treatment option for people with nummular eczema who don't get relief from steroid creams.
- What could go wrong
- This is an early-stage Phase 3 trial, so results are not yet known. The drug may not work better than placebo, 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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 years and older
- 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: 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.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alm Site 1
RECRUITINGFreiburg im Breisgau, 79106, Germany
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