Cure My Disease

Don't miss your cure!

 Log in / Sign up

New biologic drug aims to clear stubborn eczema in just 24 weeks

NCT ID NCT05990725

Disease control Sponsor: Almirall, S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether lebrikizumab, an injectable biologic, can improve skin symptoms in adults and adolescents (aged 12 and older) with moderate-to-severe atopic dermatitis, also known as eczema. Participants receive lebrikizumab for 24 weeks, and doctors measure changes in eczema severity using a standard skin score. The goal is to see if this treatment can reduce redness, thickening, and itching enough to make a real difference in daily life.

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 injectable biologic drug
What this could lead to
If successful, lebrikizumab could offer a new treatment option for people with moderate-to-severe eczema, helping to clear skin and reduce itching.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects from lebrikizumab are possible, and it may not work for everyone.

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

260 people

The number who actually took part.

Started

Nov 2023

Finished

Jun 2025

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

12 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: * Adults and adolescents (aged \>=12 to less than \[\<\] 18 years at the time of informed consent form (ICF)/informed assent form (IAF) signature and weighing \>=40 kg) who are candidates for systemic AD therapy. * Chronic AD that has been present for \>=1 year before the Screening visit. * EASI score \>=12 at the Day 1/Baseline Visit. * IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit. * \>=10% BSA of AD involvement at the Day 1/Baseline visit. * History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. * Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before Day 1/Baseline. * Willing and able to comply with all clinic visits and study-related procedures and questionnaires. * For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 4 weeks or 1 menstrual period after the last dose of lebrikizumab. * Participant must provide signed ICF. Adolescent participants must also provide separate informed assent to enroll in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements). Exclusion Criteria: * Prior treatment at any time with tralokinumab, lebrikizumab, or an oral JAK inhibitor. * Intention to use any concomitant medication or therapy 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 bursts of oral corticosteroids, example, co-morbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score \>=1.5 or a history of \>=2 asthma exacerbations within the last 12 months requiring systemic \[oral and/or parenteral\] corticosteroid treatment or hospitalisation for \>24 hours). * Occurrence of the following types of infection within 3 months of Screening or develop any of these infections before Day 1/Baseline: 1. Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion); 2. Opportunistic 3. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer); 4. Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). * Known current or chronic infection with hepatitis B virus. * Known liver cirrhosis and/or chronic hepatitis of any aetiology. * Known active endoparasitic infections or at high risk of these infections. * Known or suspected history of immunosuppression, including history of invasive opportunistic infections (example, 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. * Any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit that would jeopardise the patient's participation in the study, per the Investigator's judgement. * 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 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 his/her 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atopic dermatitis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

atopic eczema dermatitis Eczema skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis Eczema

Contacts and locations

Locations

  • Site 1

    Kiel, Germany

  • Site 10

    Lübeck, Germany

  • Site 11

    Erlangen, Germany

  • Site 12

    Oberhausen, Germany

  • Site 13

    München, Germany

  • Site 14

    York, United Kingdom

  • Site 15

    Hamburg, Germany

  • Site 17

    München, Germany

  • Site 18

    Tübingen, Germany

  • Site 19

    Langenau, Germany

  • Site 2

    Potsdam, Germany

  • Site 22

    Oldenburg, Germany

  • Site 23

    Heidelberg, Germany

  • Site 26

    Mainz, Germany

  • Site 27

    Dresden, Germany

  • Site 28

    Düsseldorf, Germany

  • Site 29

    Bonn, Germany

  • Site 3

    Hamburg, Germany

  • Site 30

    Regensburg, Germany

  • Site 32

    Freiburg im Breisgau, Germany

  • Site 33

    München, Germany

  • Site 34

    Augsburg, Germany

  • Site 35

    Bergen op Zoom, Netherlands

  • Site 36

    Marburg, Germany

  • Site 37

    Frankfurt, Germany

  • Site 38

    Leeds, United Kingdom

  • Site 4

    Münster, Germany

  • Site 41

    Utrecht, Netherlands

  • Site 5

    Göttingen, Germany

  • Site 6

    Mannheim, Germany

  • Site 7

    Rostock, Germany

  • Site 8

    Hamburg, Germany

  • Site 9

    Berlin, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.