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New shot could help eczema sufferers who Don't respond to steroids

NCT ID NCT07542483

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Alm Site 1

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

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