Scientists probe whether lebrikizumab rewires diseased skin at the molecular level

NCT ID NCT06906497

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are studying lebrikizumab, an approved injectable drug for atopic dermatitis, to understand how it changes skin biology over time. The trial enrolls 48 people with moderate-to-severe atopic dermatitis who have not done well on topical treatments. Participants receive lebrikizumab injections for up to 60 weeks, and researchers collect blood and skin samples to track molecular changes in the skin. The goal is to learn whether the drug leads to long-term improvement at the level of gene activity and skin barrier function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lebrikizumab, an approved injectable drug for atopic dermatitis
What this could lead to
If it works, this could explain why some people with atopic dermatitis improve on lebrikizumab and others do not, which may help doctors choose treatments.
What could go wrong
The trial is small, with 48 participants, and it studies a drug already approved, so it will not produce a new medicine. Skin biopsy findings may not translate into practical guidance for patients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 48 people

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

Started

Jul 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

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: * Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable. * Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score =3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits. * Subject has an Eczema Area and Severity Index (EASI) score =16 at screening and baseline. * Subject has a pruritus NRS =4. * Subject is biologic naïve. * Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for at least 17 weeks after the last study drug (SD) injection, when this is in line with the preferred and usual lifestyle of the subject, or to use a highly-effective and approved method of contraception throughout the study and for at least 17 weeks after the last study drug injection. * Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements. * Understand and sign an informed consent form (ICF) (and assent form, when applicable) before any investigational procedure(s) are performed. Exclusion Criteria: * Previous treatment with lebrikizumab or participation in a lebrikizumab study. * History of anaphylaxis as defined by the Sampson criteria. * Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit. * Prior treatment with dupilumab or tralokinumab. * Treatment with any of the following agents within 4 weeks prior to the baseline visit: 1. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi), azathioprine, methotrexate). 2. Phototherapy and photochemotherapy (PUVA) for AD. * Treatment with the following prior to the baseline visit: 1. An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer. 2. Cell-depleting biologics, including to rituximab, within 6 months. 3. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. * Use of prescription moisturizers within 7 days of the baseline visit. * Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit. * Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study. * Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma requiring systemic \[oral and/or parenteral\] corticosteroid treatment or hospitalization for \> 24 hours). * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, anti-parasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves. * Evidence of active acute or chronic hepatitis (as defined by the Department of Health \& Human Services Centers for Disease Control and Prevention) or known liver cirrhosis. * Diagnosed active endoparasitic infections or at high risk of these infections. * Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis \[TB\], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment. * History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * In the Investigator's opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history. * Presence of skin comorbidities that may interfere with study assessments. * History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. * Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the patient's 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 patient because of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. 20\. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the 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

  • Lausanne University Hospital

    Lausanne, CH-1011, Switzerland

  • Physioseq USA - CA

    Folsom, California, 95630, United States

  • University of Freiburg

    Freiburg im Breisgau, 79104, Germany

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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